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Showing 20 of 30222 trials
Examining and Comparing the Temporal Changes and Results of Cosmetic, Quality of Life and Patient Satisfaction Achieved With Immediate and Delayed-immediate Implant-based Breast Reconstruction Procedures and Contralateral Symmetrization Techniques
NCT04356235
Recruiting
Conditions Mastectomy; Lymphedema, Breast Cancer, Q...
Phase Not Applicable
Enrollment 528
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • A: expander-silicone implant exchange and contralateral symmetrization with mastopexy and if needed with volume reduction
  • B: expander-silicone implant exchange with contralateral symmetrization with mastopexy and Ultrapro sling
  • C: expander-silicone implant exchange and contralateral symmetrization with mastopexy and silicone implant augmentation
  • D: expander-silicone implant exchange and contralateral symmetrization with mastopexy and Utrapro sling and silicone implant augmentation
  • E: unilateral simple mastectomy

Primary Outcomes

  • Quality of life: BREAST-Q validated questionnaire
  • Patient satisfaction: BREAST-Q validated questionnaire
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2020-04-27
Completion: 2027-04-10
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 528 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: National Institute of Oncology, Hungary
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • A: expander-silicone implant exchange and contralateral symmetrization with mastopexy and if needed with volume reduction
  • B: expander-silicone implant exchange with contralateral symmetrization with mastopexy and Ultrapro sling
  • C: expander-silicone implant exchange and contralateral symmetrization with mastopexy and silicone implant augmentation
  • D: expander-silicone implant exchange and contralateral symmetrization with mastopexy and Utrapro sling and silicone implant augmentation
  • E: unilateral simple mastectomy
Study Locations (1 sites)
National Institute of Oncology, Budapest, 1122 Hungary
Eligibility Criteria
Inclusion Criteria: * Under the age of 65 with uni- or bilateral primary breast cancer ( clinical Stage 0-III), needing modern skin sparing mastectomy, nipple sparing mastectomy or areola sparing mastectomy independently of the axillary surgery, having immediate or delayed-immediate implant based reconstrucion on the ipsilateral side and symmetrisation on the contralateral side ( mastopexy and/or implant based reconstruction and/or breast sling with ultrapro mesh) * Control group: patients under 65 years with unilateral simplex mastectomy without breast reconstruction Exclusion Criteria: * In case the patient does not volunteer for the examination or the follow-ups * Age above 65 years or poor general health condition, where the estimated life expectancies would be less than 2 years even without the tumorous disease * Malignant invasive tumor in the past history (except for non-melanoma skin tumors) * Mastectomyand reconstruction performed due pregnancy associated breast cancer * Prior breast surgery (e.g. aesthetic surgery, mastopexy) and/or radiotherapy on the breast or in the axilla * Malignant tumor is not removed completely with pathological examination * Severe non-surgical (e.g. radiotherapy) complication, which could influence the aesthetic and functional results * Autoimmune diseases * Mastitis carcinomatosa * Lymphangitis carcinomatosa * Open wound therapy due SSI * Long-term steroid usage, which changed the skin's quality and structure * Patient under foster care, or psychically non-cooperative patient * If breast correction performed during the 5 years follow up
Pembrolizumab, IRX-2, and Chemotherapy in Triple Negative Breast Cancer
NCT04373031
Active, positions filled
Conditions Breast Cancer, Breast Neoplasms
Phase PHASE2
Enrollment 12
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Pembrolizumab
  • IRX 2

Primary Outcomes

  • Pathological Complete Response (pCR) Rate (ypT0/Tis ypN0)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2020-12-30
Completion: 2026-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 12 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Providence Health & Services
Collaborators: Merck Sharp & Dohme LLC, Brooklyn ImmunoTherapeutics, LLC
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Pembrolizumab
  • IRX 2
Study Locations (1 sites)
Providence Portland Medical Center, Portland, Oregon 97213 United States
Eligibility Criteria
Inclusion Criteria: 1. Be willing and able to provide written informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research. 2. Be a male or female subject greater than or equal to 18 years of age on day of signing informed consent. 3. Have locally confirmed TNBC, as defined by the most recent ASCO/CAP guidelines. 4. Have previously untreated locally advanced non-metastatic (M0) TNBC defined as the following combined primary tumor (T) and regional lymph node (N) staging per the current AJCC Version 8 staging criteria for breast cancer staging criteria as assessed by the investigator based on radiological and/or clinical assessment: * T1c, N1-N2 * T2, N0-N2 * T3, N0-N2 * T4a-d, N0-N2 Note: bilateral tumors (i.e., synchronous cancers in both breasts) and/or multi-focal (i.e., 2, separate lesions in the same quadrant)/multi-centric (i.e., 2 separate lesions in different quadrants) tumors are allowed, as well as inflammatory breast cancer, and the tumor with the most advanced T stage should be used to assess the eligibility. 5. Provide a core needle biopsy consisting of at least 1 separate tumor-bearing cores from the primary tumor at screening for translational research (archival is acceptable if sufficient tumor is available; slides are acceptable if at least 15 are available) 6. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 14 days of treatment initiation. 7. Demonstrate adequate organ function. All screening labs should be performed within 14 days of treatment initiation. 8. Have left ventricular ejection fraction (LVEF) of ≥50% or ≥ institution lower limit of normal (LLN) as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed at screening. 9. Males and female subjects of childbearing potential (Section 5.7.2 - Contraception) must be willing to use an adequate method of contraception as outlined in Section 5.7.2 - Contraception, for the course of the study through 12 months after the last dose of study medication for subjects who have received cyclophosphamide, and 6 months after the last dose of study medication for subjects who did not. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. 10. (Female subject of childbearing potential) Have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or borderline a serum pregnancy test will be required. Exclusion Criteria: 1. Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. 2. Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months. 3. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) or has previously participated in MK-3475 clinical trials. 4. Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 4 weeks of the first dose of treatment in this current trial. Note: subject should be excluded if he/she received an investigational agent with anti-cancer or anti-proliferative intent within the last 12 months. 5. Has received a live vaccine within 30 days of the first dose of study treatment. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines, and are not allowed. 6. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. 7. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. 8. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). 9. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected). 10. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. 11. Has an active infection requiring systemic therapy. 12. Has significant cardiovascular disease, such as: * History of myocardial infarction, acute coronary syndrome or coronary angioplasty/stenting/bypass grafting within the last 6 months * Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA class III or IV 13. Has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject's participation for the full duration of the trial in the opinion of the Investigator. 14. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial in the opinion of the Investigator. 15. Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 12 months after the last dose of trial treatment for subjects who have received cyclophosphamide, and for 6 months after the last dose of study medication for subjects who have not. 16. Has a known hypersensitivity to the components of the study therapy or its analogs. 17. Has a known history of active TB (Bacillus Tuberculosis). 18. Allergy to ciprofloxacin (or other quinolones).
CONFIRM: Magnetic Resonance Guided Radiation Therapy
NCT04368702
Recruiting
Conditions Gastric Cancer, Invasive Breast Cancer, ...
Phase NA
Enrollment 70
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Viewray MRIdian® Linac

Primary Outcomes

  • Number of Patients and delivering MR-image guided radiation-Phase I
  • Tumor Assessment with MR Guidance-Phase I
  • Patient reported outcomes (PROMs) -Phase II
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2021-05-01
Completion: 2029-06-18
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 70 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Brigham and Women's Hospital
Principal Investigators:
  • Raymond Mak, MD (PRINCIPAL_INVESTIGATOR) - Dana-Farber Cancer Institute
Contact Information
Study Contact:
Raymond Mak, MD
6177328651
rmak@partners.org
Interventions
  • Viewray MRIdian® Linac
Study Locations (2 sites)
Brigham & Women's Hospital, Boston, Massachusetts 02115 United States
Dana Farber Cancer Institute, Boston, Massachusetts 02115 United States
Eligibility Criteria
Inclusion Criteria: * Participants must have histologically or cytologically confirmed malignancy requiring radiation * Age 18 years of older * ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A) * Ability to understand and the willingness to sign a written informed consent document. * Any further criteria listed in the specific disease site cohort Exclusion Criteria * History of allergic reactions attributed to gadolinium-based IV contrast \-- Note: If patient will not receive contrast, this is not applicable and kidney function will not affect eligibility * Severe claustrophobia or anxiety * Participants who cannot undergo an MRI * Any other exclusion criteria listed in the specific disease site cohort
Study of RP2 Monotherapy and RP2 in Combination With Nivolumab in Patients With Solid Tumors
NCT04336241
Active, positions filled
Conditions Cancer
Phase PHASE1
Enrollment 36
Locations 6 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • RP2
  • nivolumab

Primary Outcomes

  • Percentage of adverse events (AEs)
  • Percentage of serious adverse events (SAEs)
  • Percentage of dose limiting toxicities (DLTs)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Active, positions filled
Start Date: 2019-10-17
Completion: 2026-10-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 36 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Replimune, Inc.
Principal Investigators:
  • Gary Vanasse, MD (STUDY_DIRECTOR) - Replimune, Inc.
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • RP2
  • nivolumab
Study Locations (6 sites)
Hospital Universitario d'Hebron, Barcelona, 119 08035 Spain
Hospital Universitario HM Sanchinarro, Madrid, 10 28050 Spain
Hospital Clinico de Valencia, Valencia, 46010 Spain
The Clatterbridge Cancer Centre NHS Foundation Trust, Bebington, Merseyside CH63 4JY United Kingdom
The Royal Marsden NHS Foundation Trust, London, SW3 6JJ United Kingdom
Churchill Hospital, Oxford, OX3 9DU United Kingdom
Eligibility Criteria
Inclusion Criteria: * Willing and able to participate and comply with all trial requirements and able to provide signed and dated informed consent prior to initiation of any trial procedures * Male or Female ≥ 18 years of age * Patients with advanced or metastatic non-neurological solid tumors, who have progressed on standard therapy or cannot tolerate standard therapy, or for which there is no standard therapy preferred to enrolment in a clinical trial * Consent to provide archival tumour biopsy samples within 6 months, or a fresh tumour biopsy is needed. Patients must also consent to provide on-treatment biopsies as per protocol * At least one measurable and injectable tumor of ≥ 1 cm in longest diameter (or shorter diameter for lymph nodes). * Women of child-bearing potential (WOCBP) must have a negative urine pregnancy test at screening and a negative urine pregnancy test prior to administration of each dose of RP2 or nivolumab * WOCBP must agree to use adequate birth control throughout their participation and for 3 months after RP2 alone and 5 months after nivolumab last study treatment * Males with partners of child-bearing potential must agree to use adequate birth control throughout their participation and for 3 months for RP2 alone and 7 months after nivolumab last study treatment * Have laboratory values (obtained ≤ 28 days prior to first infusion day) in accordance with the study protocol * Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 Cohort 2a only: * Baseline ECG that does not show abnormalities according to the protocol * Baseline troponin \< 0.06 ng/mL * Baseline oxygen saturation levels that do not show abnormalities according to the protocol Cohort 2b and Part 3 only: * Patients in Cohort 2b should have histologically or cytologically confirmed diagnosis of advanced or metastatic uveal melanoma, lung cancer, breast cancer, or gastrointestinal cancers (including but not limited to colorectal cancer \[CRC\] \[microsatellite stable\], gastric cancer, gastroesophageal junction cancer, and oesophageal cancer) (n=30) * Patients with HCC and a diagnosis of hepatitis B must be off antiviral therapy for at least 4 weeks prior to enrollment. * Patients with acute or chronic hepatitis B or C must be expected to not require antiviral therapy during the RP2 treatment period. * Patients with HCC who have evidence of acute or chronic hepatitis C infection must have completed treatment for hepatitis C at least 1 month prior to study enrollment * Patients in Part 3 should have solid tumours (excluding skin cancers) that the investigator deems suitable for RP2 monotherapy, including at least 10 patients with liver metastases from prevalent tumour types (e.g. lung, breast \[including recurrent chest wall\], and gastrointestinal cancers \[colorectal, gastric, and oesophageal cancers\]) (n=15) * Patient has progressed during or after one to three prior systemic anticancer therapies for advanced or metastatic disease or during or within six months of receiving adjuvant therapy. Patients who, in the opinion of the investigator, are deemed not appropriate candidates for standard-of-care systemic anticancer therapy for advanced or metastatic disease, or who, after documented consultation with their treating physician, refuse standard-of-care systemic anticancer therapy may be eligible after discussion with the medical monitor Exclusion Criteria: * Prior treatment with an oncolytic virus therapy * History of viral infections according to the protocol * Systemic infection requiring IV antibiotics within 14 days prior to dosing * Prior complications with herpes infections * Chronic use of anti-virals * Systemic therapies for cancer within five half-lives or 4 weeks of first dose; whichever is shorter * Conditions that require certain doses of steroids (some doses and types will be permitted) * Known active brain metastases - previously treated brain metastases may be permitted * Major surgery ≤ 2 weeks prior to starting study drug * Prior malignancy active with the previous 3 years; except for locally curable cancers that have apparently been cured * Female who has a positive urine pregnancy test or is breast-feeding or planning to become pregnant during study treatment and 90 days for RP2 alone or 5 months for RP2 and nivolumab after the last dose of treatment * Participation in another clinical study within 4 weeks prior to the first dose * History of myocarditis or congestive heart failure (as defined by the New York Heart Association Functional Classification III or IV), or unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction within 6 months of randomization * History of allergy or sensitivity to study drug components * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study Part 2 patients only: * Participants with history of life-threatening toxicity related to prior immune therapy except those that are likely to re-occur with standard countermeasures * Treatment with botanical preparations within 2 weeks prior to treatment * Certain autoimmune diseases, some types will be permitted * History of interstitial lung disease * Severe hypersensitivity to another monoclonal antibody * Has received radiotherapy within 2 weeks of start of study treatment * Has received a live vaccine within 28 days prior to first dose of study drug * History of non-infectious pneumonitis * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study * Other serious or uncontrolled medical disorders Cohort 2b and Part 3 (only for the subset of patients with liver metastases suitable and intended for injection) * Presence of liver metastases that are estimated to invade more than one-third of the liver * Macroscopic intravascular invasion into the main portal vein, hepatic vein or vena cava * Significant bleeding event within the last 12 months that places the patient at risk for intrahepatic intratumoral injection procedure based on investigator assessment * Prior chemoembolization, radioembolization, or other locoregional liver-directed procedures to the lesion selected for intratumoral injection
Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications
NCT04354545
Recruiting
Conditions Glaucoma, Ocular Surface Disease
Phase Not Applicable
Enrollment 75
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Xiidra (Lifitegrast ophthalmic solution) 5%

Primary Outcomes

  • Change from baseline to week 12 in corneal fluorescein staining score
  • Change from baseline to week 12 in eye dryness score (EDS)
  • Change from baseline to week 12 in ocular surface disease index (OSDI) questionnaire score
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2021-04-01
Completion: 2026-12-01
Eligibility
Age: No restriction
Sex: ALL
Volunteers: true
Enrollment: 75 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of California, Los Angeles
Collaborators: Bausch & Lomb Incorporated
Contact Information
Study Contact:
Benjamin B Bert, MD
626-817-4701
BBert@mednet.ucla.edu
Mayra Raygoza
16268174747
Mraygoza@mednet.ucla.edu
Interventions
  • Xiidra (Lifitegrast ophthalmic solution) 5%
Study Locations (1 sites)
Doheny Eye Center UCLA, Fountain Valley, California 92708 United States
Eligibility Criteria
Inclusion Criteria: * Currently using one or more topical glaucoma antihypertensives * Self-described symptoms of ocular surface discomfort * Xiidra is being prescribed as part of the subject's standard care Exclusion Criteria: * History of glaucoma filtration surgery, history of ocular surface surgery (pterygium, conjunctivoplasty, etc.), * current use of topical cyclosporine * current use of topical steroids * incisional ocular surgery within 6 months
Physiological-based Cord Clamping in Congenital Diaphragmatic Hernia
NCT04373902
Active, positions filled
Conditions Hernias, Diaphragmatic, Congenital, Hern...
Phase NA
Enrollment 140
Locations 9 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Physiological-based cord clamping

Primary Outcomes

  • Number of participants with pulmonary hypertension diagnosed in the first 24 hours after birth.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2020-05-11
Completion: 2026-07-01
Eligibility
Age: 35 Weeks
Sex: ALL
Volunteers: false
Enrollment: 140 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Erasmus Medical Center
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Physiological-based cord clamping
Study Locations (9 sites)
Monash University, Melbourne, Australia
Medical University Graz, Graz, Austria
University Hospitals leuven, Leuven, Belgium
Universitätskrankenhaus Bonn, Bonn, Germany
Universitätsklinik Mannheim, Mannheim, Germany
Ospedale Pediatrico Bambino Gesu, Rome, Italy
Radboudumc University Medical Center, Nijmegen, Netherlands
Erasmus MC University Medical Center - Sophia Children's Hospital, Rotterdam, Netherlands
Karolinska University Hospital, Stockholm, Sweden
Eligibility Criteria
Inclusion Criteria: * Left-sided CDH * Isolated CDH: no associated structural or genetic abnormalities that are diagnosed before birth * Gestational age at delivery ≥35.0 weeks * Parental written informed consent Exclusion Criteria: * Right-sided or bilateral CDH * Gestational age at delivery \<35.0 weeks * Maternal contraindications: anterior placenta praevia, placental abruption * High urgency caesarean section, with intended interval to delivery \<15 min * Cases that have been treated during pregnancy with experimental drug therapy aiming to decrease the occurrence of pulmonary hypertension * Twin pregnancies in which the infant diagnosed with a CDH is born first * Multiple birth \>2 (triplets or higher order)
Blended Care Versus Face-to-Face Therapy for Depression
NCT04337242
Active, positions filled
Conditions Major Depressive Disorder
Phase NA
Enrollment 504
Locations 6 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • B-DIT
  • B-CBT
  • DIT
  • Cognitive Behavioral Therapy

Primary Outcomes

  • Changes in depressive symptoms assessed by the Beck Depression Inventory (BDI-II) at 6-month follow-up (12 months after the start of treatment)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2019-03-29
Completion: 2026-09-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 504 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Universitaire Ziekenhuizen KU Leuven
Collaborators: Belgium Health Care Knowledge Centre, Erasmus University Rotterdam
Principal Investigators:
  • Patrick Luyten, PhD (PRINCIPAL_INVESTIGATOR) - Universitaire Ziekenhuizen KU Leuven
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • B-DIT
  • B-CBT
  • DIT
  • Cognitive Behavioral Therapy
Study Locations (6 sites)
CGG Andante, Berchem, 2600 Belgium
CGG Vagga, Berchem, 2600 Belgium
CGG Mandel & Leie, Kortrijk, 8500 Belgium
CGG VBO, Leuven, 3000 Belgium
CGG De Pont, Mechelen, 2800 Belgium
CGG Kempen, Turnhout, 2300 Belgium
Eligibility Criteria
Inclusion Criteria: * Age 18-65 * Current diagnosis of major depressive disorder with or without dysthymic disorder according to DSM 5 criteria. * PHQ score ≥ 10. Note: Use of pharmacotherapy for depression and other psychiatric disorders during the intervention is allowed (with the exception of antipsychotic medication for psychotic disorder), as this reflects routine clinical care. Of note, in routine clinical care, it is not uncommon that antipsychotic medication is prescribed for symptoms in the depressive-anxious cluster rather than for primary psychotic symptoms. Exclusion Criteria: * Current psychotic symptoms or bipolar disorder. * Current use of antipsychotic medication specifically for the treatment of primary psychotic disorder. * Severe Personality Disorder (e.g., borderline personality disorder). * Historic or current self-injury/parasuicide of such extent and/or severity that may substantially interfere with the ability to engage in brief psychotherapy. * Current excessive use of drugs/alcohol. * Not fluent in Dutch. * Clinical contra-indication to brief psychotherapy (e.g., attachment history - multiple separations, serious ongoing trauma in childhood, multiple caregivers - suggesting the need for longer-term psychotherapy). * Evidence of pervasive use of help. * Highly unstable or insecure life arrangements. * No access to computer/internet or computer illiteracy. * Participation in another depression clinical trial within the last year where the participant has received CBT or PDT.
Circulating Tumor DNA (ctDNA) for Early Treatment Response Assessment of Solid Tumors
NCT04354064
Recruiting
Conditions Healthy Volunteer, Prostate Cancer, Head...
Phase Not Applicable
Enrollment 100
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Freedom from progression
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2019-05-29
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Washington University School of Medicine
Collaborators: Roche Sequencing Solutions, The Foundation for Barnes-Jewish Hospital, National Center for Advancing Translational Sciences (NCATS), Radiological Society of North America, Skandalaris, The V Foundation for Cancer Research, National Institute of General Medical Sciences (NIGMS)
Principal Investigators:
  • Melissa Reimers, M.D. (PRINCIPAL_INVESTIGATOR) - Washington University School of Medicine
Contact Information
Study Contact:
Melissa Reimers, M.D.
314-362-7249
cbumb@wustl.edu
Interventions
N/A
Study Locations (1 sites)
Washington University School of Medicine, St Louis, Missouri 63110 United States
Eligibility Criteria
Inclusion Criteria: * Eligible healthy donors will be at least 18 years of age. Exclusion Criteria: * Healthy donors younger than 18 years of age
Additional Support Program Via Text Messaging and Telephone-Based Counseling for Breast Cancer Patients Receiving Hormonal Therapy
NCT04379570
Active, positions filled
Conditions Anatomic Stage I Breast Cancer AJCC v8, ...
Phase PHASE3
Enrollment 1167
Locations 526 sites
Compensation paid available
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Educational Intervention
  • Text Message-based Navigation Intervention
  • Motivational Interviewing
  • Best Practice
  • Questionnaire Administration

Primary Outcomes

  • Endocrine therapy (ET) adherence at 12 months post-randomization
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Active, positions filled
Start Date: 2021-02-15
Completion: 2026-08-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 1167 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Katherine E. Reeder-Hayes, MD (STUDY_CHAIR) - University of North Carolina, Chapel Hill
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Educational Intervention
  • Text Message-based Navigation Intervention
  • Motivational Interviewing
  • Best Practice
  • Questionnaire Administration
Study Locations (526 sites)
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama 35233 United States
Fairbanks Memorial Hospital, Fairbanks, Alaska 99701 United States
Arizona Center for Cancer Care - Gilbert, Gilbert, Arizona 85297 United States
Arizona Center for Cancer Care-Peoria, Peoria, Arizona 85381 United States
Cancer Center at Saint Joseph's, Phoenix, Arizona 85004 United States
Arizona Center for Cancer Care - Phoenix, Phoenix, Arizona 85027 United States
Arizona Center for Cancer Care - Osborn, Scottsdale, Arizona 85251 United States
Arizona Center for Cancer Care - Scottsdale, Scottsdale, Arizona 85258 United States
Arizona Center for Cancer Care-Surprise, Surprise, Arizona 85374 United States
Mercy Hospital Fort Smith, Fort Smith, Arkansas 72903 United States
Eligibility Criteria
* Women with an initial pathologically confirmed diagnosis of stage I-III, hormone receptor positive, HER2-neu negative, invasive breast cancer within 18 months prior to enrollment * Women who have undergone neo-adjuvant chemotherapy who have no residual invasive disease post-surgery are eligible based on an initial pathologically confirmed diagnosis * Hormone receptor positive is defined as estrogen receptor (ER) and/or progesterone receptor (PR) of \> 1% * HER2-neu negative is defined as 0-1+ by immunohistochemical (IHC) analysis, or non-amplified by fluorescence in situ hybridization (FISH) analysis * Patients must have received cancer-directed surgery, and/or completed all other adjuvant therapy, except reconstruction * Patients must have initiated an endocrine therapy drug within the 6 months prior to registration, OR have received a prescription with stated intent to initiate within 6 weeks after registration * No history of previous cancer as follows: * Invasive or non-invasive breast cancer at any time * Non-breast cancer, within the past 5 years, excluding non-melanoma skin cancer * Patients must be willing to use a smart phone for study activities * Patient is NOT to be deemed ineligible during the recruitment process if they do not have a smart phone * If a participant does not own a smart phone or has limited data or texting capabilities or their smart phone cannot support the Alliance electronic patient reported outcomes (ePRO) survey application (app), a smart phone and service can be provided to the participant at no cost through the Ohio State University (OSU) partnership with Verizon Wireless for the duration of the study activities * The CRP is ONLY to discuss this option with those patients who self-identify a phone-related barrier to participation, including: lack of a smart phone, insufficient phone plan (minutes/text/data), or a smart phone incompatible with the Alliance ePRO app * For OSU -provided phones, charges will be paid by the grant through the intervention period. At the end of the 12-month intervention period, patients will be responsible for paying monthly fees, if continued service is desired. The physical phones will belong to the patients at the end of their study activities * Patients must be willing to use a Pillsy medication event monitoring system for the duration of study participation * In order to complete the mandatory patient-completed measures, participants must be able to speak and read English
CARdiomyopathy in Type 2 DIAbetes Mellitus
NCT04303364
Active, positions filled
Conditions Cardiomyopathy, Diabetic
Phase Not Applicable
Enrollment 1256
Locations 17 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Assess the uniqueness of diabetic cardiomyopathy (DCM) relative to other forms of cardiomyopathy
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2020-10-02
Completion: 2028-04-01
Eligibility
Age: 40 Years
Sex: ALL
Volunteers: true
Enrollment: 1256 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Collaborators: Consorcio Centro de Investigación Biomédica en Red (CIBER)
Principal Investigators:
  • Geneviève DERUMEAUX, MD, PhD (PRINCIPAL_INVESTIGATOR) - Henri Mondor University Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Study Locations (17 sites)
Hopital Louis Pradel, Bron, 69677 France
Cardiology Outpatient Department at Hôpital Henri Mondor., Créteil, France
Centre Hospitalier Universitaire Grenoble Alpes, Grenoble, 38043 France
department of diabetology and nutrition, APHM, Marseille, France
Hôpital CHU- Nantes, Nantes, 44093 France
Diabetology department, Cochin Institute, Paris, 75015 France
Diabetology departement, Lariboisière Hospital, Paris, 75475 France
University Hospital Aachen, Aachen, 52074 Germany
University Hospital Heidelberg, Heidelberg, Germany
Amsterdam UMC, Amsterdam, 1100 DD Netherlands
Eligibility Criteria
Inclusion criteria * Female or male, aged between ≥ 40 and ≤80 years * Normal LVEF AND absence of akinetic segment assessed by echocardiography (i.e. LVEF≥50%) * Patients diagnosed according to the specific diagnostic criteria of each disease (Cf. table below (definition criteria)). For each group, the diagnosis will be based on current accepted criteria: * HFpEF: left ventricular ejection fraction (LVEF) LVEF≥50% AND presence/or history of symptoms (e.g. breathlessness, ankle swelling and fatigue) or signs (e.g. elevated jugular venous pressure, pulmonary crackles and peripheral oedema) of heart failure AND significant diastolic dysfunction (left atrial volume index \>34 mL/m2 or a LVMI ≥115 g/m2 for males and ≥95 g/m2 for female, E/e' ≥13 and e' \<9 cm/s) OR NT-proBNP \>125 pg/Ml * No HFpEF: LVEF≥50% AND absence of symptoms (e.g. breathlessness, ankle swelling and fatigue) or signs (e.g. elevated jugular venous pressure, pulmonary crackles and peripheral oedema) of heart failure * T2DM: HbA1c ≥ 6.5% (≥ 48 mmol/L) AND Fasting Plasma Glucose ≥7.0 mmol/L (≥126 mg/dL) or anti-diabetic treatment * Non T2DM: HbA1c \< 6.5% AND Fasting Plasma Glucose \<7.0 mmol/L without any anti-diabetic treatment including normoglycemic subjects * HCM: patients with non-obstructive HCM of sarcomeric cause (proven with common genetic cause) and with LV wall thickness ≥ 15 mm in one or more myocardial segments in the absence of abnormal afterload conditions. * Suitable echocardiographic window * Absence of history of coronary artery disease including history of myocardial ischaemia, myocardial infarction or percutaneous coronary intervention * Absence of significant coronary artery disease (CAD) defined as: * the absence of coronary artery stenosis ≥50% on a cardiac computed tomography (CT) OR a coronary angiography OR normal Fractional Flow Reserve (FFR \>0.80) OR * Coronary Artery Calcium score (CAC) \<100 performed within the 48 months before inclusion * Patient covered by a health insurance Non-inclusion criteria: * Diabetes mellitus other than type 2 (type 1, LADA, MODY, NODAT, etc.) * Suboptimal echocardiographic window * Significant valvular heart disease defined as severe aortic regurgitation or severe primary mitral regurgitation or aortic stenosis with a peak transvalvular velocity ≥3m/s or mitral stenosis with a mitral valve area \< 1.5cm² * Chronic atrial fibrillation or any significant arrhythmia at inclusion * Renal insufficiency defined as eGFR\<30 mL/min/1.73m² * History of and candidate to bariatric surgery * Obstructive hypertrophic cardiomyopathy (definition: maximal gradient at rest \<30 mmHg) * Hypertrophic cardiomyopathy due to a non-sarcomeric etiology, i.e. known infiltrative or storage disorder mimicking HCM such as Fabry disease or amyloidosis * Life threatening comorbidities (i.e. history of or active cancer treated with chemotherapy or radiotherapy, end-stage heart failure, severe lung disease, cirrhosis) * Pregnancy/Lactating mother * Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the study or which would jeopardize compliance with the protocol * Inability to understand the local language * Individuals deprived of liberty * Protected persons (under guardianship or curatorship) * Contra-indication to CMR (please see CMR-SOP): * Known hypersensitivity to gadolinium based product (including gadoteric acid and meglumine) * Known COVID-19 symptomatic infection requiring hospitalization
Effects of Sitagliptin in Individuals With Genetically Decreased DPP4
NCT04323189
Active, positions filled
Conditions Genetics Disease, Type2 Diabetes, Heart ...
Phase PHASE4
Enrollment 20
Locations 1 sites
Compensation Phase 4: Typically $100-$500
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Sitagliptin 100mg
  • Placebo Oral Tablet

Primary Outcomes

  • Dipeptidyl peptidase 4 (DPP4)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Active, positions filled
Start Date: 2020-08-26
Completion: 2026-02-28
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 20 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Pennsylvania
Principal Investigators:
  • Jessica R Wilson, MD, MS (PRINCIPAL_INVESTIGATOR) - University of Pennsylvania
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Sitagliptin 100mg
  • Placebo Oral Tablet
Study Locations (1 sites)
University of Pennsylvania, Philadelphia, Pennsylvania 19104 United States
Eligibility Criteria
Inclusion Criteria: * Participant of the Penn Medicine Biobank who is willing to be recontacted to participate in future research. * Cases are defined as adults 18-70 years with likely decreased DPP4. * Controls are defined as adults who are matched to cases by: age, gender, race, BMI, hypertension status, diabetes status, renal function, and medication use that may affect outcomes of interest. Exclusion Criteria: * The study will exclude volunteers with any significant medical conditions that may interfere with study participation, data interpretation, or pose safety risk(s) to the subject. * Recent hospitalization or acute illness such as infection within the past two weeks * Pregnancy * Use of insulin * Use of a GLP-1 agonist or DPP4 inhibitor medication * Use of oral diabetes agents other than metformin unless matched with controls * Type 1 diabetes * Chronic steroid use or use within the last 30 days * Significant liver disease including liver enzymes \>3 x upper limit of normal range * Renal dysfunction defined as eGFR\< 50mL/min/1.73m2 * Significant cardiac disease such as heart transplantation * Significant gastrointestinal conditions that may interfere with drug absorption or GLP-1 release including bariatric surgery * Significant hematologic disease such as hematocrit \<35% * Use of chronic anticoagulation * Severe pulmonary disease * Severe neurologic or psychiatric disease * Inability to comprehend study procedures
A Phase II Study of Triple-negative Breast Cancer Brain Metastases.
NCT04303988
Recruiting
Conditions Breast Cancer
Phase PHASE2
Enrollment 35
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • SHR-1316
  • Bevacizumab
  • Cisplatin/Carboplatin

Primary Outcomes

  • Overall Response Rate in the CNS
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2020-03-30
Completion: 2025-05-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 35 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Fudan University
Principal Investigators:
  • Jian Zhang, MD (PRINCIPAL_INVESTIGATOR) - Fudan University
Contact Information
Study Contact:
Jian Zhang, MD
13918273761
syner2000@163.com
Ting Li, MD
13917792964
Interventions
  • SHR-1316
  • Bevacizumab
  • Cisplatin/Carboplatin
Study Locations (1 sites)
Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality 200032 China
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years old, and ≤ 70 years old, both genders; 2. ECOG performance status 0-2; 3. Pathological tests confirm HR-negative / HER2-negative breast cancer; there is evidence of local recurrence or metastasis;not suitable with curative surgery or radiation therapy;HR negative is defined as: ER-negative and PR-negative, the proportion of positively stained tumor cells in all tumor cells is \<1%;HER2- negative is defined as: histologically confirmed to be HER2 IHC (0) or HER2 IHC(1+) or HER2 IHC (2+) and FISH(-); 4. It is required that no platinum drugs have been used before, or platinum drugs have been used (cisplatin/carboplatin only one regimen) and platinum sensitive: no progression during at least 4 cycles of treatment, more than 3 months period between last platinum regimen and the progression of disease; 5. MRI confirmed brain metastases, at least one intracranial parenchymal metastatic lesion with a longest diameter ≥ 1.0 cm without prior radiotherapy; 6. Mannitol or steroid hormone therapy is allowed before enrollment, but the dose of steroid hormone should be stable for at least one week; 7. Adequate function of major organs meets the following requirements: (1)Blood routine ANC≥1.5×109/L; PLT≥75×109/L; Hb≥90 g/L(Allows blood transfusion or the use of medication to ensure that the content of hemoglobin) (2)Coagulation: INR≤1.5,APTT≤1.5×ULN, PT does not exceed the upper limit of normal (3)Blood biochemistry TBIL≤1.5 × ULN; ALT and AST≤3 × ULN (liver metastasis≤5.0 × ULN); Urea nitrogen ≤ 1.5 × ULN; Cr≤1.5 × ULN or creatinine clearance ≥50 mL / min (Cockcroft-Gault formula) (4)Cardiac ultrasound: LVEF≥50%; (5)12-lead ECG: females QTcF interval \<470msec and males \<450ms; 8.Willing to join the study, sign informed consent, have good compliance and cooperate with follow-up. Exclusion Criteria: 1. Leptomeningeal or cystic metastases confirmed by MRI or lumbar puncture. 2. Presence of third interstitial fluid that cannot be controlled by drainage or other methods (e.g., a large amount of pleural effusion and ascites); 3. Whole brain radiotherapy, chemotherapy or surgery within 14 days prior to enrollment. Has received prior therapy with Targeted therapy or Endocrine therapy within the previous week; 4. Subjects with HR-/HER2- who has received prior therapy with bevacizumab or PD-1/PD-L1; 5. Participation in any other clinical trials within 2 weeks of enrollment; 6. Concurrent use of any other Anti-cancer drugs; 7. Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma; 8. History of heart disease: (1) Arrhythmias requiring medical treatment or clinical significance, (2) Myocardial infarction, (3) Heart failure, (4)Any heart diseases that investigator believes not suitable for this study; 9. History of allergy or hypersensitivity to any of the study drugs or study drug components; 10. History of immunodeficiency including HIV-positive, active hepatitis B/C, other acquired, congenital immunodeficiency disease or history of organ transplantation; 11. A clear history of neurological or mental disorders, including epilepsy or dementia; 12. Pregnant or breastfeeding women. Women of childbearing potential who have a positive pregnancy test or unwilling to use adequate contraception prior to enrollment and for the duration of study participation; 13. According to the investigator's judgment, there is a concomitant disease that seriously endangers the safety of subjects or affects the completion of the study (including but not limited to severe hypertension, severe diabetes, active infection, thyroid disease that cannot be controlled by drugs); 14. Any condition which in the investigator's opinion makes the subjects unsuitable for the study participation.
Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer
NCT04290793
Active, positions filled
Conditions Breast Cancer
Phase PHASE2, PHASE3
Enrollment 113
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Pyrotinib
  • Epirubicin
  • Cyclophosphamide
  • Taxanes
  • Trastuzumab

Primary Outcomes

  • tpCR
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2, PHASE3
Status: Active, positions filled
Start Date: 2020-03-01
Completion: 2026-12-10
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 113 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Hebei Medical University Fourth Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Pyrotinib
  • Epirubicin
  • Cyclophosphamide
  • Taxanes
  • Trastuzumab
Study Locations (1 sites)
The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei China
Eligibility Criteria
Inclusion Criteria: 1. Female breast cancer patients at the age of \>= 18 years and \<= 70 years who received first treatment; 2. Pathologically confirmed HER2-positive invasive breast cancer(which is defined as the immunohistochemistry score of \> 10% immunoreactive cells being 3+ or in situ hybridization results showing HER2 gene amplification),regardless of hormone receptor status (ER and PR); 3. According to the 2019 CSCO BC guidelines: When HER-2 positive is used as the standard for preoperative neoadjuvant therapy for breast cancer, the tumor is larger than 2 cm; 4. The Eastern Tumor Collaborative Group (ECOG) has a physical status score of ≤1; 5. The functional level of the main organs must meet the following requirements : 1) blood routine test: hemoglobin (Hb) ≥ 90g/L;Neutrophils (ANC) ≥ 1.5 × 10\^9/L; platelet count (PLT) ≥ 90 × 10\^9/L; 2) Blood biochemistry: Total bilirubin (TBIL) ≤ 1.5 upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; Urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) Heart color ultrasound: Left ventricular ejection fraction (LVEF) ≥ 55%; 6. Women of childbearing age, tested negative for serum pregnancy test 7 days before randomization,and willing to use appropriate methods during the trial and within 8 weeks after the last administration of the test drug; 7. A volunteer to participate in the study; provision of written informed consent; good compliance and willing to cooperate during the follow-up. Exclusion Criteria: 1. Known history of hypersensitivity to pyrotinib or any of it components; 2. Patients have previously received antitumor treatment or radiation therapy for any malignant tumor (except for cervical carcinoma in situ and basal cell carcinoma that have been cured); 3. Patients underwent major breast cancer-free surgery within 4 weeks and have not fully recovered; 4. Subjects that are unable to swallow tablets,intestinal obstruction or dysfunction of gastrointestinal absorption; 5. Patients with severe heart disease or discomfort who cannot be treated; 6. The patient suffers from mental illness or psychotropic substance abuse and cannot cooperate; 7. Pregnant or lactating women; 8. Less than 4 weeks from the last clinical trial; 9. Patients participating in other clinical trials at the same time 10. The researchers think inappropriate.
The DBCG Proton Trial: Photon Versus Proton Radiation Therapy for Early Breast Cancer
NCT04291378
Recruiting
Conditions Early Breast Cancer, Radiation Associate...
Phase NA
Enrollment 1502
Locations 8 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Proton versus photon radiation therapy

Primary Outcomes

  • Radiation associated ischaemic and valvular heart disease
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2020-06-01
Completion: 2037-06-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 1502 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Danish Breast Cancer Cooperative Group
Principal Investigators:
  • Birgitte V Offersen, phd (PRINCIPAL_INVESTIGATOR) - Danish Breast cancer Cooperation Group (DBCG)
Contact Information
Study Contact:
Birgitte V Offersen, phd
+45 28838012
birgoffe@rm.dk
Morten Høyer, phd
+45 23282823
morthoey@rm.dk
Interventions
  • Proton versus photon radiation therapy
Study Locations (8 sites)
Aalborg University Hospital, Aalborg, Denmark
Aarhus University Hospital, Aarhus, Denmark
The Danish Breast Cancer Cooperative Group, Copenhagen, DK-2100 Ø Denmark
Rigshospitalet, Copenhagen, Denmark
Herlev Hospital, Herlev, Denmark
Naestved Hospital, Næstved, Denmark
Odense University Hospital, Odense, Denmark
Vejle Hospital, Vejle, Denmark
Eligibility Criteria
Inclusion Criteria: * Patient operated for early breast cancer with indication for radiation therapy, where standard planning shows a mean heart dose 4 Gy or more and/or a V20 lung of 37% or more. * Boost (breast, chest wall and nodal), breast reconstruction (any type, except implants with metal), connective tissue disease, post-operative surgical complications, any breast size and seromas are allowed * Patient with previous non-breast malignancy is accepted if the patient has been without disease minimum 5 years, and the treating oncologist estimates a low risk of recurrence. * Life expectancy minimum 10 years Exclusion Criteria: * previous breast cancer/ductal carcinoma in situ, * Previous RT to the chest region * Pregnant or lactating * Conditions indicating that the patient cannot go through the RT or follow up * Patients with Pacemaker or defibrillator are excluded until a guideline for handling them has been developed at the DCPT * Unknown non-tissue implants upstream of the target volume. NB. all such non-tissue, non-metal objects must be delivered to the DCPT for stopping power determination and evaluation at least a week prior to radiation start. * Metal implants in the radiation area, including metal in implants.
Postmastecomy Internal Mammary Nodal Irradiation for High-risk Breast Cancer Patients
NCT04320979
Active, positions filled
Conditions Breast Cancer
Phase PHASE3
Enrollment 2400
Locations 1 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • internal mammary nodal irradiation
  • no internal mammary nodal irradiation

Primary Outcomes

  • disease-free survival
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Active, positions filled
Start Date: 2020-05-08
Completion: 2030-05
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 2400 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborators: Hebei Medical University Fourth Hospital, Shanghai Zhongshan Hospital, Zhejiang Cancer Hospital, Beijing Hospital, Liaoning Cancer Hospital & Institute, Jilin Provincial Tumor Hospital, Tangshan People's Hospital, The First Hospital of Jilin University, West China Hospital, Peking Union Medical College Hospital, Henan Cancer Hospital, Zhongnan Hospital, Peking University Cancer Hospital & Institute, Fudan University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Air Force Military Medical University, China, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Chinese Academy of Medical Sciences, Fuwai Hospital, Lanzhou University First Hospital, Jiangsu Province Hospital of Traditional Chinese Medicine, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Principal Investigators:
  • Shu-lian Wang, M.D (PRINCIPAL_INVESTIGATOR) - Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Ye-xiong Li, M.D (STUDY_CHAIR) - Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • internal mammary nodal irradiation
  • no internal mammary nodal irradiation
Study Locations (1 sites)
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, 100021 China
Eligibility Criteria
Inclusion Criteria: * Eastern Cooperative Oncology Group Performance Status Scale 0-2 * Histologically confirmed invasive breast cancer * Underwent total mastectomy/breast-conserving surgery and axillary dissection(10 or more axillary lymph nodes detected) and negative margins * Patients who had ≥4 positive axillary lymph nodes; or 1-3positive axillary lymph nodes and T3-4; or 1-3positive axillary lymph nodes and T1-2, and score≥3 based on the following high risk factors: age≤40 years(score 1), primary tumor in the inner quadrant (score 1), 2-3 positive axillary lymph nodes (score 1), positive vascular invasion (score 1), re-staged based on eighth Cancer Staging System staging system(IB-IIA score 1, IIB-IIIA score 2); or ypN+ after neoadjuvant chemotherapy * No supraclavicular or internal mammary nodes metastases based on images before system therapy * No distant metastases * Could tolerate radiotherapy * Treated with chemotherapy (anthracycline and/or taxane-based combined chemotherapy, ≥6 cycles) * Anticipated to receive endocrine therapy for 5 years if indicated * Anticipated to receive anti-HER2 therapy for 1 years if indicated * LVEF≥50% based on echocardiogram * Willing to follow up * Written,informed consent Exclusion Criteria: * Simultaneous bilateral breast cancer * Sentinel lymph node biopsy only without axillary dissection * Had received internal mammary node dissection * No imaging assessment of the internal mammary nodal before system therapy * One-stage breast reconstruction * Severe cardiac insufficiency; myocardial infarction or uncorrected unstable arrhythmia or uncorrected unstable angina in the last 3 months; pericardial disease * Had history of chest wall or supraclavicular radiotherapy * Had simultaneous or previous secondary malignancies, except for non-malignant melanoma skin cancer, papillary thyroid / follicular carcinoma, cervical carcinoma in situ, contralateral non-invasive breast cancer
PATH 2 Purpose: Primary Care and Community-Based Prevention of Mental Disorders in Adolescents
NCT04290754
Active, positions filled
Conditions Depression
Phase NA
Enrollment 636
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • CATCH-IT
  • TEAMS

Primary Outcomes

  • Time
  • Cultural acceptability adolescent and family
  • Cost
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2020-01-01
Completion: 2026-10-01
Eligibility
Age: 13 Years
Sex: ALL
Volunteers: true
Enrollment: 636 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: University of Illinois at Chicago
Collaborators: University of Illinois College of Medicine Rockford, Wake Forest University Health Sciences, Katherine Shaw Bethea Hospital, University of Louisville, Patient-Centered Outcomes Research Institute, Brown University, Mile Square Health Center
Principal Investigators:
  • Benjamin W Van Voorhees, MD, MPH (PRINCIPAL_INVESTIGATOR) - University of Illinois at Chicago, School of Medicine
  • Tracy RG Gladstone, PhD (PRINCIPAL_INVESTIGATOR) - Wellesley College, Wellesley Centers for Women
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • CATCH-IT
  • TEAMS
Study Locations (1 sites)
UI Health, Chicago, Illinois 60612 United States
Eligibility Criteria
Inclusion Criteria: * Adolescents ages 13 through 19 years, and * Adolescent must be experiencing an elevated level of depressive symptoms (Patient Health Questionnaire-9 Score = 5-18), and * Adolescent will be included if they have a past, but not current history of depression. Exclusion Criteria: * Outside age range * A current diagnosis of Major Depression * Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) diagnosis of: schizophrenia, bipolar affective disorder, extreme current drug or alcohol abuse. * Currently using medication therapy for depression, anxiety, or other internalizing disorders for less than 3 months. * Currently engaged in individual treatment for a mood disorder * Currently engaged in a cognitive-behavioral group or therapy * Any past psychiatric hospitalizations * Any past self-harm attempt with moderate or greater lethality * Current suicidal thoughts * Not willing to comply with the study protocol * Not willing to participate in the TEAMS groups * Not willing to be audio recorded during TEAMS groups (only for TEAMS clinics) * Unable to complete the PHQ-9 screening due to cognitive or intellectual impairment * Did not complete phone assessment with MINI Kid * Parent/guardian has a cognitive or intellectual impairment. * Participant Declined/Changed Mind/Uninterested in participating
Circulating Tumor DNA and Immunophenotyping as Potential Biomarkers With Regional Nodal Irradiation for Breast Cancer
NCT04308720
Active, positions filled
Conditions Breast Cancer
Phase Not Applicable
Enrollment 217
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Changes in the ctDNA detection
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2019-10-01
Completion: 2028-10-20
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 217 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Mayo Clinic
Principal Investigators:
  • Robert W. Mutter, M.D. (PRINCIPAL_INVESTIGATOR) - Mayo Clinic Radiation Oncology
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Study Locations (1 sites)
Mayo Clinic in Rochester, Rochester, Minnesota 55905 United States
Eligibility Criteria
Inclusion Criteria: * 18 years of age or older * Histologically confirmed primary or recurrent non-metastatic invasive breast cancer with plans for adjuvant post-lumpectomy or post-mastectomy radiation therapy at the Mayo Clinic and indications for regional nodal irradiation. * Or patients undergoing curative intent irradiation for oligometastatic breast cancer (=\< 3 sites of metastases) is permitted * Willingness to provide informed consent and expresses understanding of this protocol and its requirements, risks, and discomforts * Patients with non-metastatic breast cancer must have completed their final breast surgery including re-excision of margins for invasive cancer and ductal carcinoma in situ (DCIS) or chemotherapy within 90 days prior to registration but no sooner than 21 days prior to the initiation of radiation therapy (RT). * Bilateral breast cancer is permitted * Positive or close margins is allowed Exclusion Criteria: * Other active malignancy =\< 2 years prior to registration (exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix) * Pregnancy or lactation * Inability on the part of the patient to understand the informed consent to be compliant with the protocol
National Cancer Institute "Cancer Moonshot Biobank"
NCT04314401
Active, positions filled
Conditions Acute Myeloid Leukemia, Anatomic Stage I...
Phase Not Applicable
Enrollment 1600
Locations 150 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Biospecimen Collection
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Medical Chart Review
  • Paracentesis

Primary Outcomes

  • Procure, store and distribute longitudinal biospecimens and associated clinical data
  • Percentage of enrolled patients by cancer type and treatment regimen overall
  • Percentage of minority and underserved study participants accrued
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2020-11-11
Completion: 2027-04-30
Eligibility
Age: 13 Years
Sex: ALL
Volunteers: false
Enrollment: 1600 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: National Cancer Institute (NCI)
Principal Investigators:
  • Lyndsay N Harris (PRINCIPAL_INVESTIGATOR) - National Cancer Institute (NCI)
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Biospecimen Collection
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Medical Chart Review
  • Paracentesis
Study Locations (150 sites)
Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis, Daphne, Alabama 36526 United States
Thomas Hospital, Fairhope, Alabama 36532 United States
Mobile Infirmary Medical Center, Mobile, Alabama 36607 United States
Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland, Saraland, Alabama 36571 United States
Kingman Regional Medical Center, Kingman, Arizona 86401 United States
Mercy Hospital Fort Smith, Fort Smith, Arkansas 72903 United States
PCR Oncology, Arroyo Grande, California 93420 United States
AIS Cancer Center at San Joaquin Community Hospital, Bakersfield, California 93301 United States
Veterans Affairs Loma Linda Healthcare System, Loma Linda, California 92357 United States
Salinas Valley Memorial, Salinas, California 93901 United States
Eligibility Criteria
Inclusion Criteria: * Is consistent with OR has been diagnosed with one of the following: * Colorectal cancer: stage IV * Non-small cell or small cell lung cancer: stage III/IV * Prostate cancer: metastatic prostate cancer * Gastric cancer, not otherwise specified (NOS): stage IV * Esophageal cancer, NOS: stage IV * Adenocarcinoma of gastroesophageal junction: stage IV * High grade serous ovarian cancer: stage III/IV * Invasive breast carcinoma: stage III/IV * Melanoma: stage III/IV * Acute myeloid leukemia * Multiple myeloma * For the purposes of this study, * Re-staging is allowed * Having more than one primary cancer is allowed, if the patient is being treated solely for one of the eligible cancers listed above * Patient should fit in one of the following four clinical scenarios (a-d) * Undergoing diagnostic workup for one of the diseases listed for which treatment will likely include a new regimen of standard of care therapy OR * Scheduled to begin treatment with a new regimen of standard of care therapy OR * Currently progressing on a regimen of standard of care therapy OR * Currently being treated with a regimen standard of care therapy, without evidence of progression * Requirements for fresh tissue biospecimen collections at enrollment: * For clinical scenarios a, b, and c above, freshly collected tumor tissue or bone marrow (BM) aspirate must be submitted at enrollment * For clinical scenarios a and b, the fresh tissue collection must be prior to starting therapy * For clinical scenario a, the biospecimen collection must be part of a standard of care medical procedure * For clinical scenarios b or c, the biospecimen collection may be part of a standard of care medical procedure OR * The biospecimen collection may be part of a study-specific procedure ("research only biopsy"), when the patient has a tumor amenable to image guided or direct vision biopsy and is willing and able to undergo a tumor biopsy for molecular profiling * Note: For research-only biopsies, the biopsy must not be associated with a significant risk of severe or major complications or death; the procedure cannot be a mediastinal, laparoscopic, open or endoscopic biopsy; nor can the procedure be a brain biopsy; nor can the patient be under the age of majority as determined by each U.S. state * Requirements for archival tissue: * For clinical scenarios a and b above, archival tissue as outlined below must be submitted IF AVAILABLE * For clinical scenarios c and d above, archival tissue as outlined below is REQUIRED * Pre-existing archival material (formalin-fixed, paraffin-embedded \[FFPE\] block, BM aspirate, or unstained slides) that: * Contains the cancer type for which the participant is enrolled, and * Was collected no more than 5 years prior to initiation of therapy, and * Contains at least a surface area of 5 mm\^2 and optimal surface area of 25 mm\^2 or 3-5 mL cryopreserved bone marrow aspirate to yield 200 million bone marrow mononuclear cells, and * Contains at least 10% tumor content. 70% tumor content is optimal, and * No more than 1 line of standard of care systemic therapy was administered from the date of archival material collection to the date of initiation of therapy * Requirements for blood collection: ALL scenarios require fresh blood collection at enrollment * Blood collection for clinical scenarios a, b, and c must take place within 1 week of fresh tumor specimen collection * Blood collection for clinical scenario d must take place within 4 weeks of enrollment, and while patient is on treatment * Age 13 or older * Any sex * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 * Ability to understand and willingness to sign an informed consent document. Consent may be provided by a Legally Authorized Representative (LAR) in accordance with 45 CFR 46.102(i) * NCI PDMR INCLUSION CRITERIA: Patients with CRC with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) status * NCI PDMR INCLUSION CRITERIA: Patients with CRC who are 40 years old or younger at time of collection irrespective of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) status * NCI PDMR INCLUSION CRITERIA: Patients with BRCA that are either * Any race/ethnicity with hormone receptor positive (ER+PR+, ER+PR-, or ER-PR+) * African American with triple negative (ER-PR-HER2-) * NCI PDMR INCLUSION CRITERIA: Patients with lung cancer (LCA), prostate cancer (PCA), gastroesophageal cancer (GEC), ovarian cancer (OV), acute myeloid leukemia (AML), multiple myeloma (MML) Exclusion Criteria: * Treated with or has already begun treatment with a non-standard of care therapeutic agent (investigational) in an interventional clinical trial * For the purposes of this study, past enrollment in clinical trials whereby the patient was randomized and treated with standard-of-care anti-cancer treatment (chemotherapy regimen, surgery and radiation therapy) is allowed * Uncontrolled intercurrent illness that in the physician's assessment would pose undue risk for biopsy * Use of full dose coumarin-derivative anticoagulants such as warfarin are prohibited. Patients may be switched to low molecular weight (LMW) heparin at physician discretion * Low molecular weight (LMW) heparin is permitted for prophylactic or therapeutic use * Factor X inhibitors are permitted * Use of anti-platelet drugs are permitted * Stopping the anticoagulation treatment for biopsy, bone marrow aspirate, or resection should be per site standard operating procedure (SOP) * NCI PDMR EXCLUSION CRITERIA: Patients with complete response * NCI PDMR EXCLUSION CRITERIA: Patients with invasive fungal infections * NCI PDMR EXCLUSION CRITERIA: Patients with active and/or uncontrolled infections or who are still recovering from an infection * Actively febrile patients with uncertain etiology of febrile episode * All antibiotics for non-prophylactic treatment of infection should be completed at least 1 week (7 days) prior to collection * No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics * NCI PDMR EXCLUSION CRITERIA: Patients with human immunodeficiency virus (HIV), active or chronic hepatitis (i.e. quantifiable hepatitis B virus \[HBV\]-deoxyribonucleic acid \[DNA\] and/or positive hepatitis B surface antigen \[HbsAg\], quantifiable hepatitis C virus \[HCV\]-ribonucleic acid \[RNA\]) or known history of HBV/HCV without documented resolution
GammaPod Dose Escalation Radiation for Early Stage Breast Cancer
NCT04234386
Recruiting
Conditions Breast Cancer
Phase NA
Enrollment 50
Locations 4 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • GammaPod Radiation

Primary Outcomes

  • Establish the single-fraction radiation dose (MTD)
  • Incidence of Dose-Limiting Toxicities (DLTs)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2021-09-15
Completion: 2030-12
Eligibility
Age: 45 Years
Sex: FEMALE
Volunteers: false
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Maryland, Baltimore
Principal Investigators:
  • Elizabeth Nichols, MD (PRINCIPAL_INVESTIGATOR) - University of Maryland, Baltimore
Contact Information
Study Contact:
Elizabeth Nichols, MD
410-328-6080
enichols1@umm.edu
Caitlin Eggleston
410-328-7586
caitlineggleston@umm.edu
Interventions
  • GammaPod Radiation
Study Locations (4 sites)
UMMC, Baltimore, Maryland 21201 United States
Upper Chesapeake Health, Bel Air, Maryland 21014 United States
Central Maryland Oncology Center, Columbia, Maryland 21044 United States
Baltimore Washington Medical Center, Glen Burnie, Maryland 21061 United States
Eligibility Criteria
Inclusion Criteria: * Patients must sign consent for study participation. * Patients must be female with a diagnosis of invasive ductal carcinoma. Lobular histologies will not be included, because of difficulty in defining the extent of disease with imaging. * Patients must be deemed appropriate candidates for breast-conserving therapy (i.e., not pregnant, never had RT to the treated breast, breast size would allow adequate cosmesis after volume loss from partial mastectomy). * Tumor must not involve the overlying skin or underlying chest wall, based on imaging evaluation and/or clinical exam. * Greatest tumor dimension is \<3 cm based on US. MR imaging measurements can be included only if performed BEFORE the biopsy (postbiopsy measurements can be larger as a result of hematoma formation or increased edema). * Tumor must be unifocal. * Patients must be \> 45 years old. * The tumor must be visible on a CT scan. * Patients must undergo MR imaging for work-up to aid in tumor delineation and to rule out additional foci of disease. If additional foci of disease are found to be present, then these must be biopsied with negative results to proceed with treatment. * The tumor must be clinically and radiographically N0 (node negative). If a suspicious node is visualized, it must be biopsied with negative results. * Patients must be estrogen-receptor positive. * Patients must be HER2neu negative. * Patients must weigh \<150 kg (330 lb), which is the limit of the imaging loader. * Patients must be \<6'6" in height, again because of instrumentation limitations. * Patients must be able to lie prone for treatment. * Patients must have no lymphovascular invasion on biopsy. * Patients may be taking hormonal therapy prior to initiation of treatment. This will be documented. Exclusion Criteria: * Multicentric disease. * Prior RT to the involved breast. * Inability to fit into the immobilization breast cup because of breast size or other anatomic reasons. * Inability to obtain an adequate seal when using the immobilization breast cup. * Male sex. * Breast implants. * Patient cannot comfortably lie in the prone position (i.e., physical disability). * Patients who are planned to be treated surgically with a mastectomy. * Tumor \<5 mm from the skin surface or chest wall on clinical exam and/or radiographic imaging. * Tumor size \>3 cm. * Patients with psychiatric or addictive disorders that would preclude obtaining informed consent or study completion. * Patients who are pregnant or lactating (because of potential RT exposure to the fetus and unknown effects of RT in lactating women). * Patient unable to undergo MR imaging (e.g., because of known contrast reaction or concerns about contrast and existing health status). * Lymphovascular invasion on original biopsy. * Tumor histologies other than invasive ductal carcinoma (including invasive lobular carcinoma). * ER-negative tumors. * HER2neu-positive tumors. * Pure ductal carcinoma in situ (no invasive component). * Weight \>330 lb * Prior ipsilateral breast cancer. * Diffuse calcifications on mammogram (BIRADS 3, 4, 5).
Creative Arts Program to Reduce Burnout in Healthcare Professionals
NCT04276922
Recruiting
Conditions Burn-Out Syndrome, Post-Traumatic Stress...
Phase NA
Enrollment 195
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Visual Arts
  • Music
  • Dance/Movement
  • Writing/Poetry
  • Control

Primary Outcomes

  • Acceptability/Satisfaction of Intervention as assessed by Client Satisfaction Questionnaire (CSQ-8) scores to yield a homogeneous estimate of general satisfaction.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2020-03-01
Completion: 2025-04-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 195 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Colorado, Denver
Collaborators: National Endowment for the Arts, United States
Principal Investigators:
  • Marc Moss, MD (PRINCIPAL_INVESTIGATOR) - University of Colorado, Denver
Contact Information
Study Contact:
Rafaela Mantelli, BS
303-724-6377
rafaela.mantelli@cuanschutz.edu
Jeffrey McKeehan, MSN
303-724-6080
jeffrey.mckeehan@cuanschutz.edu
Interventions
  • Visual Arts
  • Music
  • Dance/Movement
  • Writing/Poetry
  • Control
Study Locations (1 sites)
University of Colorado - Anschutz Medical Campus, Aurora, Colorado 80045 United States
Eligibility Criteria
Inclusion Criteria: * Employed as a healthcare provider, practicing primarily in a hospital setting for at least 20 hours per week. * Positive symptoms of burnout measured via the Maslach Burnout Inventory (MBI): * emotional exhaustion score of \>17, or * depersonalization score of \>7, or * personal accomplishment score of \< 31. Exclusion Criteria: • Unwillingness to participate in any of the four creative arts interventions.