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Showing 20 of 30222 trials
Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension
NCT04032379
Recruiting
Conditions Benign Intracranial Hypertension
Phase Not Applicable
Enrollment 300
Locations 2 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Standard treatment

Primary Outcomes

  • Biomarkers of IIH (diagnostic and prognostic)
  • Visual status at conclusion of study
  • Visual status at conclusion of study
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Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2018-02-14
Completion: 2027-05-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Danish Headache Center
Collaborators: Odense University Hospital
Principal Investigators:
  • Rigmor Jensen, M.D., Dr.Med. (STUDY_DIRECTOR) - The Danish Headache Center, Rigshospitalet-Glostrup
  • Dagmar Beier, M.D., Ph.D. (STUDY_DIRECTOR) - Odense University Hospital
Contact Information
Study Contact:
Johanne Severinsen, M.D.
004538633553
johanne.juhl.severinsen@regionh.dk
Interventions
  • Standard treatment
Study Locations (2 sites)
The Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Copenhagen, Glostrup 2600 Denmark
Odense University Hospital, Department of Neurology, Odense, Region Syddanmark 5000 Denmark
Eligibility Criteria
Inclusion Criteria: 1. Able to and willing to provide informed consent 2. More than 18 years of age 3. Suspicion of IIH (based on clinical evaluation by neurologist or opthalmologist) Exclusion Criteria: 1.) Unable to consent (e.g. language, mental retardation).
Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Patients With DIABETES Mellitus (OPTIMAL-DIABETES)
NCT04040634
Active, positions filled
Conditions Diabetes Mellitus, High Blood Pressure, ...
Phase NA
Enrollment 9476
Locations 32 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Intensive Control of Systolic Blood Pressure (SBP)
  • Standard control of Systolic Blood Pressure (SBP)

Primary Outcomes

  • Time to cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure
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: 2019-08-08
Completion: 2026-05-31
Eligibility
Age: 50 Years
Sex: ALL
Volunteers: false
Enrollment: 9476 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Hospital Israelita Albert Einstein
Collaborators: Ministry of Health, Brazil
Principal Investigators:
  • Otavio Berwanger, MD, PhD (STUDY_DIRECTOR) - Hospital Israelita Albert Einstein
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Intensive Control of Systolic Blood Pressure (SBP)
  • Standard control of Systolic Blood Pressure (SBP)
Study Locations (32 sites)
Centro de Pesquisas Clínicas Dr Marco Mota, Maceió, Alagoas 57051-160 Brazil
Centro de Pesquisas em Diabetes e Doenças Endocrino-Metabólicas, Fortaleza, Ceará 60430-350 Brazil
Instituto de Estudos E Pesquisas Clinicas Do Ceara, Fortaleza, Ceará Brazil
Hospital Universitário Cassiano Antonio de Moraes, Vitória, Espírito Santo 29043-260 Brazil
Hospital Ana Nery, Salvador, Estado de Bahia 40323-010 Brazil
Instituto Hospital de Base, Brasília, Federal District 70330-150 Brazil
Universidade Federal de Goiás, Goiânia, Goiás 74605-020 Brazil
NS Clínica de Diabetes e Endocrinologia Ltda, Goiânia, Goiás 90020-090 Brazil
Hospital das Clinicas da Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais 30130-100 Brazil
Centro de Pesquisa do Hospital Santa Lúcia, Poços de Caldas, Minas Gerais 37710-005 Brazil
Eligibility Criteria
Inclusion Criteria: * Systolic Blood Pressure (SBP) between 130 and 180 mm Hg: * 130 to 150 mm Hg (if on 0-4 medications) * 130 to 160 mm Hg (if on 0-3 medications) * 130 to 170 mm Hg (if on 0-2 medications) * 130 to 180 mm Hg (if on 0-1 medications) * Type 2 diabetes * To be considered as having a high cardiovascular risk, including AT LEAST ONE of the following factors: 1. Established cardiovascular disease (CVD), including: * Coronary artery disease: previous myocardial infarction, previous acute coronary syndrome, previous percutaneous coronary intervention, previous coronary artery bypass graft surgery, or at least 50% stenosis in a main coronary artery associated with typical angina pectoris; or * Cerebrovascular disease: previous stroke (except those events caused by intracranial aneurysm or arteriovenous malformation) or previous transient ischemic attack (TIA), stable for at least 2 weeks preceding inclusion in the study; or * Carotid artery disease: previous carotid endarterectomy, previous percutaneous intervention with carotid stent implantation, or stenosis of at least 50% in a carotid shown by the Doppler ultrasonography, CT angiography or MR angiography; or * Peripheral artery disease: prior surgical or percutaneous revascularization of a peripheral artery, limb amputation due to vascular cause, abdominal aortic aneurysm ≥ 5 cm (with or without prior surgical or percutaneous repair), or stenosis of at least 50% in a peripheral artery associated to intermittent claudication. 2. Subclinical CVD, including: * Coronary calcium score ≥ 300 Agatston units; or * Ankle-brachial index ≤ 0.90 in the last two years; or * Left ventricular hypertrophy on the electrocardiogram, echocardiogram or other cardiac imaging exam in the last two years. 3. Chronic kidney disease (CKD): ▪ Definition of CKD: glomerular filtration rate (GFR) between 20 and 59 ml/min/1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI). 4. Additional cardiovascular risk factors, including: * Active smoking: Defined as regular use of cigarettes or other tobacco products, such as cigars and pipe, in the last six months; * Dyslipidemia: Defined as LDL cholesterol \> 70 mg/dL or non-HDL cholesterol \> 100 mg/dL in patients with previous CVD; or LDL cholesterol \> 100 mg/dL or non-HDL cholesterol \> 130 mg/dL in patients without previous CVD; or Triglycerides \> 200 mg/dL or HDL \< 40 mg/dL regardless of treatment; or use of statins or other lipid lowering medication; or * Age ≥ 75 years Exclusion Criteria: * Refusal to provide written informed consent * Body mass index \> 45 kg/m2 * Known secondary cause of hypertension * Severe renal dysfunction with GFR \< 20 mL/min/1.73m2 calculated by the CKD-EPI equation * Angina at rest Class IV Canadian Cardiovascular Society (CCS) * Acute coronary syndrome in the last six months * Symptomatic heart failure Class IV New York Heart Association (NYHA) or ejection fraction \< 35% on Doppler echocardiography in the last six months * Factors that at the research team´s judgment may limit adherence to the intervention and study protocol, including, but not limited to, the following examples: * Recent history of alcohol and illicit drug abuse * Psychiatric comorbidities (severe depression, schizophrenia, psychosis, etc.) * History of poor medication adherence and attendance to consultations * Any plans to move the city of residence in the next four years * Any plans to leave the city of residence for more than three months in the next few years * Living in the same residence of another patient previously included in this study * Patients currently enrolled in another study for CVD prevention, including those evaluating pharmacological and non-pharmacological interventions * Pregnancy or breastfeeding
Improving Cognition After Cancer
NCT04049695
Active, positions filled
Conditions Breast Cancer Survivors, Cognitive Dysfu...
Phase NA
Enrollment 253
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Exercise
  • Control

Primary Outcomes

  • National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test
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: 2019-09-09
Completion: 2025-02-01
Eligibility
Age: 40 Years
Sex: FEMALE
Volunteers: false
Enrollment: 253 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: University of California, San Diego
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Exercise
  • Control
Study Locations (1 sites)
Moores UCSD Cancer Center, La Jolla, California 92093 United States
Eligibility Criteria
Inclusion Criteria: * breast cancer survivors who have completed active treatment at least 6 months prior to enrollment and are within 5 years of diagnosis of stage 1, 2, or 3 breast cancer * self-report difficulties with cognition since their cancer diagnosis * self-report low levels of moderate to vigorous physical activity * have a Fitbit compatible device with internet * breast cancer was treated with chemotherapy and/or hormonal therapy Exclusion Criteria: * medical condition that could make it potentially unsafe to be in an unsupervised physical activity intervention * currently taking tamoxifen or aromatase inhibitor that will be stopped in the next 6 months * unable to commit to a 12-month study
Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC
NCT04055493
Active, positions filled
Conditions Breast Cancer Female
Phase PHASE3
Enrollment 1684
Locations 86 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Ribociclib 200Mg Oral Tablet

Primary Outcomes

  • invasive disease-free survival (iDFS)
  • distant disease-free survival (dDFS)
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: 2019-07-02
Completion: 2027-07-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 1684 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: West German Study Group
Collaborators: Novartis, Genomic Health®, Inc.
Principal Investigators:
  • Nadia Harbeck, Prof. Dr. (PRINCIPAL_INVESTIGATOR) - Ludwigs-Maximilians-University Munich, Breast Cancer Centre
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Ribociclib 200Mg Oral Tablet
Study Locations (86 sites)
Ost-Alb Klinikum Brustzentrum, Aalen, Baden-Wurttemberg 73430 Germany
Stadtklinik Baden-Baden Brustzentrum, Baden-Baden, Baden-Wurttemberg 76532 Germany
Kreiskliniken Böblingen Klinikum Böblingen Frauenklinik, Böblingen, Baden-Wurttemberg 71032 Germany
Uniklinikum Freiburg Frauenklinik, Freiburg im Breisgau, Baden-Wurttemberg 79106 Germany
Praxis für interdisziplinäre Onkologie & Hämatologie GbR Praxis am Diakonieklinikum, Freiburg im Breisgau, Baden-Wurttemberg 79110 Germany
SLK-Kliniken-Heilbronn Frauenklinik, Heilbronn, Baden-Wurttemberg 74078 Germany
Klinikum Ludwigsburg Klinik für Frauenheilkunde u. Geburtshilfe, Ludwigsburg, Baden-Wurttemberg 71640 Germany
Universitätsklinikum Tübingen Universitäts-Frauenklinik, Tübingen, Baden-Wurttemberg 72016 Germany
Universitätsfrauenklinik Ulm Frauenheilkunde und Geburtshilfe, Ulm, Baden-Wurttemberg 89075 Germany
GRN Klinik Weinheim Gynäkologie, Weinheim, Baden-Wurttemberg 69469 Germany
Eligibility Criteria
Inclusion Criteria: Patients eligible for inclusion in this study have to meet all of the following criteria: A. Prior to REGISTRATION in the study: 1\. Written informed consent prior to any screening procedures. 2. Female. 3. ≥ 18 years of age. 4a. EITHER: (Post)menopausal status at the time of initiation of (neo)adjuvant study medication * patient underwent bilateral oophorectomy, or * age ≥ 60, or * age \< 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and/or FSH and estradiol in the postmenopausal range per local normal range. 4b. OR: Pre-menopausal patients: * confirmed negative serum pregnancy test (β-hCG) before starting study treatment, or * patient has had a hysterectomy. 5. Histologically confirmed diagnosis of primary estrogen-receptor positive and/or progesterone-receptor positive (\> 1%) early breast cancer by local laboratory. 6\. Patient has HER2-negative breast cancer defined as * a negative in-situ hybridization test or an IHC status of 0, 1+, or 2+, * if IHC is 2+, a negative in-situ hybridization (FISH, CISH, or SISH) test is required (based on the most recently analyzed tissue sample and all tested by a local laboratory). 7\. Local therapy of breast cancer (if adjuvant treatment or planned if neoadjuvant treatment) according to current guidelines. Note: This may include radiotherapy of breast cancer. B. Prior to RANDOMIZATION in the study 8. No evidence of distant metastasis (confirmed prior to randomization by, preferentially, CT thorax / abdomen, X-ray chest, ultrasound liver, bone scan, or PET-CT). 9\. Patient has available tumor tissue from diagnostic biopsy. 10. Patient is classified as intermediate risk according to the ADAPT intermediate-risk definition (i) (as follows), or (only in case of missing Oncotype DX or Ki-67 response data), according to the clinical intermediate-risk definition (ii) (as follows). (i). ADAPT intermediate-risk definition: Patient meets one of the following criteria: * c/pN0, RS ≤ 25 with luminal-B-like (Ki-67 ≥20% or G3) or c/pT2-4 without endocrine response (post-endocrine Ki-67 \> 10 %) * c/pN1, RS ≤ 25 without endocrine response (post-endocrine Ki-67 \> 10 %) * c/pN0, RS \> 25 with luminal-B-like (Ki-67 ≥20% or G3) or c/pT2-4 with endocrine response (Ki-67 ≤ 10 %) * c/pN1, RS \> 25 with endocrine response (Ki-67 ≤ 10 %) * c/pN2-3, RS ≤ 25 with endocrine response (Ki-67 ≤ 10 %). Note: Postmenopausal patients with pT1-2/pN0 disease and RS \< 25, as well as premenopausal patients with pT1-2/pN0 disease and RS\<16, are recommended to be treated by endocrine therapy alone and not to be randomized (at investigator´s discretion). (ii). Clinical intermediate-risk definition (ascertained by investigator): Clinical intermediate risk may be ascertained by the investigator prior to randomization if at maximum two of the following three risk factors are present (according to primary diagnosis / 1st sample): 1. cT2-4 2. c/pN positive 3. G3 and / or Ki-67 ≥ 20% Note: Inclusion of a patient according to "clinical intermediate risk" is permitted only in case of missing baseline Oncotype DX® or Ki-67 decrease. In this case, investigators will follow a risk-based, step-wise assessment process. 11\. No contraindication for (neo)-adjuvant ET. 12. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 13. Patient has adequate bone marrow and organ function as defined by the following laboratory values: * absolute neutrophil count ≥ 1.5 × 109/L, * platelets ≥ 100 × 109/L, * hemoglobin ≥ 9.0 g/dL, * estimated glomerular filtration rate (eGFR) ≥ 30 mL/min by a Cockcroft-Gault formula, * INR ≤ 1.5, * serum creatinine \< 1.5 mg/dL, * total bilirubin \< ULN, except for patients with Gilbert's Syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN, * aspartate transaminase (AST) \< 2.5 × ULN, * alanine transaminase (ALT) \< 2.5 × ULN. 14. 2-lead-ECG (CANKADO) with: * QTcF interval at screening \< 450 msec (using Fridericia's correction), * mean resting heart rate 50-90 bpm (determined from the ECG). 15. Ability to swallow ribociclib tablets or to administer other study medication, respectively. 16\. Ability to communicate with the investigator and comply with study procedures. 17\. Willing to remain during therapy at the clinical site, as required by the protocol. Exclusion Criteria: Patients eligible for inclusion in this study must not meet any of the following criteria: 1. Patient with distant metastases of breast cancer beyond regional lymph nodes. 2. Patient has received prior (neo)-adjuvant treatment with chemotherapy, ET, or any CDK4/6 inhibitor for breast cancer. 3. Patient has received tamoxifen, raloxifene, or aromatase inhibitors (AIs) for reduction in risk ("chemoprevention") of breast cancer and/or treatment for osteoporosis within last 2 years prior to screening. 4. Patient has received prior neoadjuvant/adjuvant treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin or 900 mg/m² or more for epirubicin. 5. Patient with a known hypersensitivity to any of the excipients of ribociclib, ET, or standard-of-care chemotherapy. 6. Patient with inflammatory breast cancer at screening. 7. Patient is concurrently using other anti-cancer therapy. 8. Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects. 9. Patient is currently receiving warfarin or other coumarin-derived anti-coagulant for treatment, prophylaxis, or otherwise. 10. Patient has not recovered from clinical and laboratory acute toxicities related to prior anticancer therapies to NCI CTCAE version 5.0 Grade ≤ 1. 11. Patient has a concurrent malignancy, or malignancy within 5 years of randomization, or known history of invasive breast cancer. 12. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small-bowel resection). 13. Patient has a known history of HIV infection. 14. Patient has known active hepatitis-B-virus (HBV) or hepatitis-C-virus (HCV) infection. 15. Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator´s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study, or compromise compliance with the protocol (e.g., chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial, or viral infections, etc.). 16. Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following: * history of myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to study entry, * documented cardiomyopathy, * left ventricular ejection fraction (LVEF) \< 50 % as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO), * long QT syndrome, family history of idiopathic sudden death, congenital long QT syndrome, or any of the following: * risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/ symptomatic bradycardia, * concomitant medications with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued or replaced by safe alternative medication (e.g., within 5 half-lives or 7 days prior to starting study drug), * inability to determine the QTcF interval, * clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left-bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II, and 3rd-degree AV
Educational and Cultural Engagement and Incidence of Health Adverse Events
NCT03987360
Active, positions filled
Conditions Older Adults, Depression, Cognitive Decl...
Phase Not Applicable
Enrollment 30000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Observational

Primary Outcomes

  • Depression
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: 2020-03-31
Completion: 2025-07-31
Eligibility
Age: 50 Years
Sex: ALL
Volunteers: false
Enrollment: 30000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Jewish General Hospital
Principal Investigators:
  • Olivier Beauchet, MD (PRINCIPAL_INVESTIGATOR) - Jewish General Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Observational
Study Locations (1 sites)
Jewish General Hospital, Montreal, Quebec H3T 1E2 Canada
Eligibility Criteria
Inclusion Criteria: * Being 50 years and over * Being enrolled in the Canadian Longitudinal Study on Aging * Actively involved in social and cultural activities Exclusion Criteria: * Never enrolled in the Canadian Longitudinal Study on Aging * Less than 50 years old
Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Dry Powder Inhalation of Treprostinil
NCT03992755
Active, positions filled
Conditions Primary Pulmonary Hypertension
Phase PHASE3
Enrollment 92
Locations 25 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • LIQ861 Inhaled Treprostinil

Primary Outcomes

  • Number of participants with treatment emergent adverse events (AEs).
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: 2019-07-18
Completion: 2025-05-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 92 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Liquidia Technologies, Inc.
Collaborators: Nuventra, Inc.
Principal Investigators:
  • Nicholas S Hill, MD (PRINCIPAL_INVESTIGATOR) - Tufts Medical Center
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • LIQ861 Inhaled Treprostinil
Study Locations (25 sites)
Banner University Medical Center, Phoenix, Arizona 85006 United States
Arizona Pulmonary Specialists, Ltd., Phoenix, Arizona 85012 United States
West Los Angeles VA Healthcare Center, Los Angeles, California 90073 United States
UC Davis Medical Center, Sacramento, California 95817 United States
Los Angeles Biomedical Research Center, Torrance, California 90502 United States
University of Colorado Anschutz Medical Campus, Aurora, Colorado 80045 United States
University of Florida, Gainesville, Florida 32610 United States
Mayo Clinic-Jacksonville, Jacksonville, Florida 32224 United States
AdventHealth, Orlando, Florida 32803 United States
Emory University School of Medicine, Atlanta, Georgia 30322 United States
Eligibility Criteria
Inclusion Criteria: 1. Evidence of a personally signed and dated informed consent document exists indicating that the patient has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures. 2. Patient is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Patient has fulfilled all entry criteria at the time of enrollment in original study with LIQ861. 4. Patient has completed the protocol defined end of study procedures or met a protocol-defined and adjudicated endpoint in the original LIQ861 study in which they were enrolled. 5. Patient, whether male or female, agrees to use a medically acceptable method of contraception throughout the entire study period from informed consent through the termination visit, if the possibility of conception exists. Eligible male and female patients must also agree not to participate in a conception process (e.g., actively attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) during the study and for 30 days after the last dose of LIQ861. Exclusion Criteria: 1. Patient prematurely discontinued LIQ861 due to a drug-related AE/SAE or tolerability issue in the original LIQ861 study in which they were enrolled, or patient did not complete protocol defined study procedures at an end of study visit (not Early Termination visit) in their original LIQ861 study. 2. Patient withdrew consent during participation in another LIQ861 study. 3. Patient is a female who wishes to become pregnant or who has a positive pregnancy test on Day 1 (LTI-302 Study Initiation Visit). 4. Patient has undergone lung or heart/lung transplant or the initiation of parenteral (intravenous \[IV\] infusion or subcutaneous injection) therapy with a prostacyclin during the time since participation in their original LIQ861 study. 5. Any reason exists that, in the opinion of the Investigator or Medical Monitor, precludes the patient from participating in the study, e.g., any previous or intercurrent medical condition that may increase the risk associated with study participation or that would confound study analysis or impair study participation or cooperation.
A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer
NCT03975647
Active, positions filled
Conditions HER2-positive Breast Cancer
Phase PHASE3
Enrollment 466
Locations 490 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • tucatinib
  • placebo
  • T-DM1

Primary Outcomes

  • Progression-Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 Based on Investigator Assessment
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: 2019-10-02
Completion: 2029-03-10
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 466 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Seagen, a wholly owned subsidiary of Pfizer
Principal Investigators:
  • Pfizer CT.gov Call Center (STUDY_DIRECTOR) - Pfizer
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • tucatinib
  • placebo
  • T-DM1
Study Locations (490 sites)
University of South Alabama Health Children's and Women's Hospital, Mobile, Alabama 36604 United States
University of South Alabama Mitchell Cancer Institute, Mobile, Alabama 36604 United States
University of South Alabama Health University Hospital, Mobile, Alabama 36617 United States
Banner Gateway Medical Center, Gilbert, Arizona 85234 United States
Banner MD Anderson Cancer Center, Gilbert, Arizona 85234 United States
Western Regional Medical Center, LLC, Goodyear, Arizona 85338 United States
Arizona Oncology Associates, PC - HOPE., Tucson, Arizona 85704 United States
Arizona Oncology Associates, PC - HOPE, Tucson, Arizona 85704 United States
Arizona Oncology Associates, PC - HOPE, Tucson, Arizona 85711 United States
UCLA Hematology/Oncology - Alhambra, Alhambra, California 91801 United States
Eligibility Criteria
* Inclusion Criteria: * Histologically confirmed HER2+ breast carcinoma as determined by a sponsor-designated central laboratory * History of prior treatment with a taxane and trastuzumab in any setting, separately or in combination * Have progression of unresectable locally advanced/metastatic breast cancer after last systemic therapy, or be intolerant of last systemic therapy * Measurable or non-measurable disease assessable by RECIST v1.1 * ECOG performance status score of 0 or 1 * CNS Inclusion - Based on screening contrast brain magnetic resonance imaging (MRI), participants must have at least one of the following: (a) No evidence of brain metastases (b) Untreated brain metastases not needing immediate local therapy (c) Previously treated brain metastases 1. Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy, provided that there is no clinical indication for immediate re-treatment with local therapy 2. Participants treated with CNS local therapy for newly identified lesions or previously treated and progressing lesions may be eligible to enroll if all of the following criteria are met: (i) Time since SRS is at least 7 days prior to first dose of study treatment, time since WBRT is at least 14 days prior to first dose, or time since surgical resection is at least 28 days. (ii) Other sites of evaluable disease are present 3. Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions * Exclusion Criteria: * Prior treatment with tucatinib, afatinib, trastuzumab deruxtecan (DS-8201a), or any other investigational anti-HER2, anti-EGFR, or HER2 TKI agent. Prior treatment with lapatinib or neratinib within 12 months of starting study treatment (except in cases where they were given for ≤21 days and was discontinued for reasons other than disease progression or severe toxicity). Prior treatment with pyrotinib for recurrent of mBC (except in cases where pyrotinib was given for ≤21 days and was discontinued for reasons other than disease progression or severe toxicity). * CNS Exclusion - Based on screening contrast brain magnetic resonance imaging (MRI), participants must not have any of the following: 1. Any untreated brain lesions \>2 cm in size 2. Ongoing use of corticosteroids for control of symptoms of brain metastases at a total daily dose of \>2 mg of dexamethasone (or equivalent). 3. Any brain lesion thought to require immediate local therapy 4. Known or concurrent leptomeningeal disease as documented by the investigator 5. Poorly controlled generalized or complex partial seizures
A Study of Limited Heart Monitoring During Non-anthracycline Trastuzumab-based Therapy in Breast Cancer Patients
NCT03983382
Active, positions filled
Conditions Breast Cancer
Phase Not Applicable
Enrollment 190
Locations 8 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Left Ventricular Ejection Fraction

Primary Outcomes

  • Frequency of Cardiac Adverse Events, Defined by a Compositive of Clinical Heart Failure (NYHA Class III or IV) or Cardiac Death.
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: 2019-03-22
Completion: 2027-03
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 190 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Memorial Sloan Kettering Cancer Center
Principal Investigators:
  • Anthony Yu, MD (PRINCIPAL_INVESTIGATOR) - Memorial Sloan Kettering Cancer Center
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Left Ventricular Ejection Fraction
Study Locations (8 sites)
Hartford Healthcare Cancer Institute @ Hartford Hospital (Data collection only), Hartford, Connecticut 06102 United States
Memorial Sloan Kettering Cancer Center @ BaskingRidge (Consent and follow-up only), Basking Ridge, New Jersey 07920 United States
Memorial Sloan Kettering Monmouth (Consent and Follow up), Middletown, New Jersey 07748 United States
Memorial Sloan Kettering Bergen (Consent and follow-up only), Montvale, New Jersey 07645 United States
Memorial Sloan Kettering Cancer Center @ Commack (Consent and Follow up), Commack, New York 11725 United States
Memorial Sloan Kettering Westchester (Consent and Follow-up), Harrison, New York 10604 United States
Memorial Sloan Kettering Cancer Center, New York, New York 10065 United States
Memorial Sloan Kettering Nassau (Consent and Follow-up), Rockville Centre, New York 11553 United States
Eligibility Criteria
Inclusion Criteria: * Age \>/= 18 years * Newly diagnosed histologically confirmed primary invasive breast carcinoma (Stage I-IV) * Pathologically confirmed HER2-positive breast cancer * Planned to receive trastuzumab-based therapy for a minimum of 12 months, or started trastuzumab-based therapy within the last weeks with a planned duration of at least 12 months. * Normal LV systolic function (EF greater than or equal to the institutional lower limit of normal) * William and able to comply with the requirements of the protocol Exclusion Criteria: * Planned to receive an anthracycline-based regimen * Prior history of treatment with anthracycline chemotherapy * History of cardiovascular including cardiomyopathy, heart failure, or any other clinically significant cardiovascular disease (as determined by the investigator) * Uncontrolled hypertension, defined as systolic blood pressure \>/= 160 mmHg and/or diastolic blood pressure \>/= 90 mmHg (as determined by the investigator)
Cardiopulmonary Toxicity of Thoracic Radiotherapy
NCT03978377
Recruiting
Conditions Oesophageal Cancer, Non Small Cell Lung ...
Phase Not Applicable
Enrollment 320
Locations 3 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Number of patients with high risk of pulmonary hypertension
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: 2018-09-01
Completion: 2027-04-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 320 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Medical Center Groningen
Contact Information
Study Contact:
CT Muijs, MD PhD
00315036115179
c.t.muijs@umcg.nl
P van Luijk, DR
0031503611739
p.van.luijk@umcg.nl
Interventions
N/A
Study Locations (3 sites)
Universitaire Ziekenhuizen Leuven, Leuven, Belgium
Radboud UMC, Nijmegen, Gelderland 6525 GA Netherlands
NHS Greater Glasgow and Clyde, Glasgow, United Kingdom
Eligibility Criteria
Inclusion Criteria: * Patients with oesophageal cancer in the mid or distal oesophagus and patients with NSCLC stage IIA-III or NSCLC stage IV with limited brain metastases (treatable with surgery or stereotactic radiosurgery) or SCLC limited disease (stage I-IIIB) * Scheduled for external-beam radiotherapy with curative intention. * WHO 0-2. * Age \>= 18 years * Written informed consent. Exclusion Criteria: * No heart failure in the last 2 months * No pulmonary embolism in the last 2 months * COPD gold IV * BMI \>35 * History of thoracic radiotherapy * Noncompliance with any of the inclusion criteria - For MRI part: Contra indications for MRI For MRI part: • contra-indications for MRI
FACILE: FeAsibility of First-line RiboCIclib in OLdEr Patients with Advanced Breast Cancer
NCT03944434
Active, positions filled
Conditions Breast Cancer
Phase PHASE2
Enrollment 116
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

  • Ribociclib
  • Aromatase Inhibitors, non steroideal
  • LHRH agonist

Primary Outcomes

  • Treatment feasibility
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: 2018-12-27
Completion: 2025-11-27
Eligibility
Age: 70 Years
Sex: ALL
Volunteers: false
Enrollment: 116 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Fondazione Sandro Pitigliani
Collaborators: Novartis
Principal Investigators:
  • Laura Biganzoli, MD (PRINCIPAL_INVESTIGATOR) - Hospital of Prato
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Ribociclib
  • Aromatase Inhibitors, non steroideal
  • LHRH agonist
Study Locations (1 sites)
Hospital of Prato, Prato, Italy 59100 Italy
Eligibility Criteria
Inclusion Criteria: 1. Patients male or female, aged 70 years-old or older at the time of informed consent. 2. Patients with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy. 3. Measurable or not measurable but evaluable disease according to RECIST criteria 1.1 4. Patient has a histologically and/or cytologically confirmed diagnosis of estrogen receptor positive and/or progesterone receptor positive breast cancer by local laboratory. 5. Patient has a HER2 negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing. 6. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2. 7. Patient has an estimated life expectancy of \> 24 weeks. 8. Patient has adequate bone marrow and organ function as defined by all of the following laboratory values (as assessed by local laboratory): 1. Absolute neutrophil count ≥1.5 x 109/L 2. Platelets ≥ 100 x 109/L 3. Hemoglobin ≥ 9.0 g/dL 4. Potassium, sodium, calcium corrected for serum albumin and magnesium within normal limits or corrected to within normal limits with supplements before first dose of the study medication 5. INR ≤ 1.5 6. Serum creatinine \<1.5 mg/dl or creatinine clearance ≥50mL/min 7. Total bilirubin \< ULN except for patients with Gilbert's syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN. 8. In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be \< 2.5 × ULN. If the patient has liver metastases, ALT and AST should be \< 5 × ULN. 9. Patient must have a 12-lead ECG values with all of the following parameters at screening: 1. QTcF interval at screening \< 450 msec (using Fridericia's correction) 2. Resting heart rate ≥50 bpm 10. Patient must be able to swallow ribociclib and NSAI tablets 11. Written informed consent must be obtained prior to any screening procedures 12. Patient must be able to communicate with the investigator and comply with the requirements of the study procedures. Exclusion Criteria: * 1\. Patient has received prior treatment with chemotherapy or hormonal therapy (except for neoadjuvant/ adjuvant chemotherapy), or any CDK4/6 inhibitor. NOTE: * Patients who received (neo) adjuvant therapy for breast cancer are eligible. If the prior neo (adjuvant) therapy included letrozole or anastrozole the disease-free interval must be greater than 12 months from the completion of treatment until study entry. * Patients who received ≤ 28 days of letrozole or anastrozole for advanced disease prior to inclusion in this trial are eligible. 2\. Patient has a known hypersensitivity to any of the excipients of ribociclib or NSAI 3. Patient in concurrently using other anti-cancer therapy. 4. Patient who has not had resolution of all acute toxic effects of prior anti-cancer therapy to NCI CTCAE version 5.0 Grade ≤ 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion). 5\. Patient who has received extended-field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to start of treatment, and who has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion). Patient from whom ≥ 25% of the bone marrow has been previously irradiated are also excluded 6. Patient has a concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer. 7\. Patient with central nervous system (CNS) metastases unless they meet all of the following criteria: 1. At least 4 weeks from prior therapy for CNS disease completion (including radiation and/or surgery) to starting the study treatment. 2. Clinically stable CNS lesions at the time of study treatment initiation and not receiving steroids and/or enzyme-inducing anti-epileptic medications for the management of brain metastases for at least 2 weeks. 8\. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection). 9\. Patient has a known history of HIV infection (testing not mandatory). 10. Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgement, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g., chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.) 11. Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following: <!-- --> 1. History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 6 months prior to screening 2. History of documented congestive heart failure (New York Heart Association functional classification III-IV) 3. Documented cardiomyopathy 4. Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g. bifascicular block, Mobitz type II and third-degree AV block) 5. Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: i. Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia ii. Concomitant medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued or replaced by safe alternative medication (within 5 half-lives or 7 days prior to starting study drug) iii. Inability to determine the QTcF interval on screening f. Systolic Blood Pressure (SBP) \>160 or \<90 mmHg 12. Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to starting study drug: 1. Concomitant medications, herbal supplements, and/or fruits (e.g. grapefruit, pummeloes, star fruit, Seville oranges) and their juices that are strong inducers or inhibitors of CYP3A4/5, 2. Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5. 13\. Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment. NOTE: * The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular)
Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer
NCT03971409
Active, positions filled
Conditions Stage III Breast Cancer, Stage IIIA Brea...
Phase PHASE2
Enrollment 145
Locations 12 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

  • Anti-OX40 Antibody PF-04518600
  • Avelumab
  • Binimetinib
  • Utomilumab
  • Liposomal Doxorubicin

Primary Outcomes

  • Best Overall Response Rate (BORR)
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: 2019-07-08
Completion: 2027-01-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 145 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Laura Huppert, MD, BA
Collaborators: Translational Breast Cancer Research Consortium, Hoosier Cancer Research Network, Array BioPharma, Pfizer, Breast Cancer Research Foundation, Johns Hopkins University, Gilead Sciences
Principal Investigators:
  • Laura Huppert, MD (PRINCIPAL_INVESTIGATOR) - University of California, San Francisco
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Anti-OX40 Antibody PF-04518600
  • Avelumab
  • Binimetinib
  • Utomilumab
  • Liposomal Doxorubicin
Study Locations (12 sites)
O'Neal Comprehensive Cancer Center, Birmingham, Alabama 35294 United States
University of California, San Francisco, San Francisco, California 94143 United States
Georgetown University, Washington D.C., District of Columbia 20057 United States
University of Chicago Medicine Comprehensive Cancer Center, Evergreen Park, Illinois 60805 United States
Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland 21218 United States
Dana-Farber Cancer Institute, Boston, Massachusetts 02215 United States
Mayo Clinic, Rochester, Minnesota 55905 United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina 27599 United States
Duke Cancer Institute, Durham, North Carolina 27710 United States
Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania 19104 United States
Eligibility Criteria
Inclusion Criteria: 1. Signed and dated written informed consent 2. Subjects \>= 18 years of age 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 4. Clinical stage IV invasive breast cancer or unresectable locoregional recurrence of invasive breast cancer meeting the following criteria: * Estrogen receptor (ER)/progesterone receptor (PR)-negative (=\< 5% cells) by immunohistochemistry (IHC) and human epidermal grow (HER2) negative (by IHC or fluorescence in situ hybridization (FISH)) * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria and which can be followed by computed tomography (CT) or magnetic resonance imaging (MRI). A measurable lytic bone lesion(s) and/or skin lesion(s) are allowed. Skin lesions must also be followed by photography with measuring tools within the photograph at each tumor evaluation time point. Ultrasound may be used to follow breast lesions not visible by CT following discussion with Study Chair * Amenable to biopsy at the time of study entry * Known tumor/immune cell PD-L1 status by any assay 5. Adequate organ function including: * Cardiac ejection fraction at or above the institutional lower limit of normal, as assessed by either echocardiogram or multigated acquisition (MUGA) scan * Absolute neutrophil count (ANC) \>= 1.0 x 10\^9/L (may have received growth factor) * Platelets \>= 100 x 10\^9/L * Hemoglobin \>= 9 g/dL (may have been transfused) * Total serum bilirubin =\< 1.5 times upper limit of normal (ULN) * Aspartate aminotransferase (AST/serum glutamic oxaloacetic transaminase (SGOT)) and alanine aminotransferase (ALT/serum glutamate pyruvate transaminase (SGPT)) =\< 2.5 x ULN (or =\< 5 x ULN if liver metastases are present) * Serum creatinine =\< 1.5 x ULN or estimated creatinine clearance \>= 50 mL/min as calculated using the Cockcroft-Gault (CG) equation * Prothrombin time (PT)/international normalized ratio (INR) =\< 1.5 x ULN * Amylase =\< 1 x ULN testing is only required in patients with a history of pancreatic disorders (Abnormality not of pancreatic origin is allowed) * Participants with treated and controlled hypo or hyperthyroidism are eligible. 6. Male and female patients of childbearing potential must agree to use at least two methods of acceptable contraception from 15 days prior to first trial treatment administration until at least 30 days after study participant's final dose of study drug(s) \* NOTE: Females of childbearing potential are defined as those who are not surgically sterile or post-menopausal (i.e., patient has not had a bilateral tubal ligation, a bilateral oophorectomy, or a complete hysterectomy; or has not been amenorrhoeic for 12 months without an alternative medical cause). Post-menopausal status in females under 55 years of age should be confirmed with a serum follicle-stimulating hormone (FSH) level within laboratory reference range for postmenopausal women 7. Patients unable to read/write in English are eligible to participate in the overall study but will not participate in the Patient-Reported Outcome questionnaires throughout the trial. 8. Re-enrollment of a subject that has discontinued the study as a pre-randomization screen failure (i.e., a consented patient who was not randomized and did not receive any study treatment) is permitted. If re-enrolled, the subject must be re-consented. Only the screening procedures performed outside of protocol-specified timing must be repeated; if biopsies and correlative blood samples were already obtained, and patient has not received any systemic anti-cancer therapy since they were obtained, they do not need to be repeated. Exclusion Criteria: 1. More than 2 lines of chemotherapy in the metastatic setting 2. More than 1 prior line of checkpoint inhibitor therapy in the metastatic setting 3. Prior treatment with sacituzumab, govitecan 4. Concurrent anticancer therapy. Required washout from prior therapies are as follows: * Chemotherapy: \>= 14 days: antibody drug conjugants administered every 3 weeks require a 3-week washout. * Major surgery: \>=14 days (provided wound healing is adequate) * Radiation: \>= 7 days * Investigational/biologic therapy (half-life =\< 40 hours): \>= 14 days * Investigational/biologic therapy (half-life \> 40 hours): \>= 28 days * Use of corticosteroids or immunosuppressive medication is exclusionary, except the following in the absence of active autoimmune disease: * Subjects are permitted the use of corticosteroids with minimal systemic absorption (e.g. topical, ocular, intra-articular, intranasal, and inhaled) * Systemic corticosteroids at physiologic doses =\< 10 mg/day of prednisone or equivalent are permitted * Adrenal replacement steroid doses including doses \> 10 mg daily prednisone are permitted * A brief (less than 3 weeks) course of corticosteroids for prophylaxis (e.g. CT scan premedication against contrast dye allergy) or for treatment of nonautoimmune conditions (e.g. delayed-type hypersensitivity reaction caused by a contact allergen) is permitted 5. Previous malignant disease other than breast cancer within the last 5 years, with the exception of basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, or low-risk cancers considered curatively treated (i.e. complete remission achieved at least 2 years prior to first dose of study drugs AND additional therapy not required while receiving study treatment) 6. All subjects with central nervous system metastases and/or carcinomatous meningitis, except those meeting the following criteria:: * Brain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to enrollment * No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable) * Subjects must be either off steroids or on a stable or decreasing dose of =\< 10 mg daily prednisone (or equivalent) 7. Receipt of any organ transplantation including allogeneic stem-cell transplantation 8. Significant acute or chronic infections including, among others: * Known history of testing positive for human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS); testing is not required for this protocol. * A history of a positive test for hepatitis B virus (HBV) surface antigen (and/or core antibody) and/or confirmatory hepatitis C virus (HCV) ribonucleic acid (RNA) (if anti-HCV antibody tested positive); testing is not required for this protocol 9. Active autoimmune disease with reasonable possibility of clinically significant deterioration when receiving an immunostimulatory agent, per investigator discretion: * Subjects requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses =\< 10 mg or 10 mg equivalent prednisone per day * Administration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) is acceptable 10. History of interstitial lung disease that is symptomatic or which may interfere with the detection or management of suspected drug-related pulmonary toxicity 11. Uncontrolled asthma (defined as having 3 or more of the following features of partially controlled asthma within 28 days prior to starting study treatment: Daytime symptoms more than twice per week, any limitation of activities, any nocturnal symptoms/awaking, need for reliever/rescue inhaler more than twice per week, or known lung function \[peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1)\] without administration of a bronchodilator that is \< 80% predicted or personal best \[if known\]) 12. Current symptomatic congestive heart failure (New York Heart Association \> class
The Role of Concomitant Diseases in Postoperative Complications Risk Stratification.
NCT03945968
Recruiting
Conditions Coronary Heart Disease, Anemia, Bronchia...
Phase Not Applicable
Enrollment 16000
Locations 38 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • incidence of postoperative complications
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: 2019-07-01
Completion: 2026-02-28
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 16000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Russian Federation of Anesthesiologists and Reanimatologists
Collaborators: Kuban State Medical University
Principal Investigators:
  • Igor Zabolotskikh, MD (PRINCIPAL_INVESTIGATOR) - Russian Federation of Anesthesiologists and Reanimatologists
Contact Information
Study Contact:
Nikita Trembach, PhD
+79528589299
nikitkax@mail.ru
Igor Zabolotskikh, MD
pobeda_zib@mail.ru
Interventions
N/A
Study Locations (38 sites)
The First City Clinical Hospital. n.a. E. E. Volosevich, Arkhangelsk, Russia
Astrakhan State Medical University, Astrakhan, Russia
Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine, Chelyabinsk, Russia
South-Ural State Medical University, Chelyabinsk, Russia
Chita state medical Academy of the Ministry of health of the Russian Federation, Chita, Russia
Kazan State Medical University, Kazan', Russia
Republic Clinical Hospital Ministry of Health care of the Republic of Tatarstan, Kazan', Russia
Research Institute for Complex Issues of Cardiovascular Diseases, Kemerovo, 650002 Russia
Regional clinical hospital №2, Krasnodar, 350012 Russia
Kuban State Medical University, Krasnodar, 350063 Russia
Eligibility Criteria
Inclusion Criteria: * surgical interventions on the abdominal organs, * 1-3 ASA physical status class Exclusion Criteria: * the inability to assess the factors included in the study, * acute massive blood loss, aspiration, * bronchospasm, * anaphylactic reactions, * malignant hyperthermia
High-Resolution Lower Dose Dedicated Breast Computed Tomography (CT)
NCT03954431
Recruiting
Conditions Breast Cancer
Phase NA
Enrollment 600
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

  • Dedicated breast CT(BCT)

Primary Outcomes

  • Diagnostic accuracy
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-08-14
Completion: 2029-12
Eligibility
Age: 40 Years
Sex: FEMALE
Volunteers: true
Enrollment: 600 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Arizona
Collaborators: National Cancer Institute (NCI), National Institutes of Health (NIH)
Principal Investigators:
  • Srinivasan Vedantham, PhD (PRINCIPAL_INVESTIGATOR) - University of Arizona
Contact Information
Study Contact:
Michele Galvan, R.T.R.
520-626-2279
mngalvan@arizona.edu
Interventions
  • Dedicated breast CT(BCT)
Study Locations (1 sites)
University of Arizona, Tucson, Arizona 85724 United States
Eligibility Criteria
Inclusion criteria: All subjects that are eligible to participate in the study will be women who satisfy all of the inclusion criteria stated below: * who are 40 years of age or older (typical screening age range) * who are undergoing or scheduled for screening or diagnostic imaging, or need a biopsy to investigate an abnormality in the breast. Exclusion criteria: Subjects that present with any of the criteria listed below will be excluded: * Males, * women less than 40 years old, * women unable to self-consent, * prisoners, * pregnant, suspected to be pregnant, or lactating women (self-reported) * women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker; * women who are unable to tolerate study constraints, frail, or unable to cooperate; * women who weigh more than 440 lbs (200 Kg), which is the weight limit for the patient support table of the BCT system; * women who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to) treatment for enlarged thymus gland as an infant, irradiation for benign breast conditions, including breast inflammation after giving birth, and treatment for Hodgkin's disease; * women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram; * women who have received large number of diagnostic x-ray examinations for monitoring of disease such as (but not limited to) tuberculosis, and severe scoliosis.
Inflammatory and Immune Profiles During a Severe Exacerbation in Preschool Asthmatic Children (<5 Years)
NCT03960359
Active, positions filled
Conditions Asthma
Phase Not Applicable
Enrollment 150
Locations 0 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Clinical, microbiological and inflammatory phenotype

Primary Outcomes

  • Inflammatory profile at exacerbation
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: 2015-02-24
Completion: 2033-02
Eligibility
Age: 1 Year
Sex: ALL
Volunteers: false
Enrollment: 150 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Hospital, Lille
Collaborators: Région Nord-Pas de Calais, France, Stallergenes Greer
Principal Investigators:
  • Antoine Deschildre, MD (PRINCIPAL_INVESTIGATOR) - University Hospital, Lille
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Clinical, microbiological and inflammatory phenotype
Eligibility Criteria
Inclusion Criteria: * Preschool children aged 1 to \< 5 years * Asthmatic / recurrent wheezers (≥ 3 discrete exacerbations since birth and/or symptoms between exacerbations, according to the definition from the French HAS and GINA guidelines) * Hospitalized (less than 3 days ago) for a severe exacerbation (requiring a course of oral steroids) * In a pediatric ward participating in the study (Hospital centers of Lille, Arras, Bethune, Douai, Lens, Roubaix, Tourcoing, Armentieres, Seclin) * Parental consent Exclusion Criteria: * History of chronic disease (other than asthma) * History of preterm birth (inf 36 weeks of amenorrhea) * Lack of understanding from the parents
Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer or Melanoma
NCT03941756
Recruiting
Conditions Anatomic Stage III Breast Cancer AJCC v8...
Phase NA
Enrollment 252
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

  • Indocyanine Green
  • Lymphangiography
  • Lymphovenous Bypass

Primary Outcomes

  • Volumetric diagnosis of lymphedema
  • Incidence of lymphedema
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2018-08-14
Completion: 2027-12-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 252 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Mark Schaverien (PRINCIPAL_INVESTIGATOR) - M.D. Anderson Cancer Center
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Indocyanine Green
  • Lymphangiography
  • Lymphovenous Bypass
Study Locations (1 sites)
M D Anderson Cancer Center, Houston, Texas 77030 United States
Eligibility Criteria
Inclusion Criteria: * Patients greater than or equal to 18 years of age. * Patients willing to participate. * Patients able to complete informed consent. * Patients will be eligible for inclusion if they fall into one for two groups: * Patients with inflammatory breast cancer, and those with locally advanced non-inflammatory breast cancer that are undergoing ALND and are anticipated to receive radiation therapy * Or: Patients with a diagnosis of melanoma (including unknown primary) that will undergo ALND will also be eligible for inclusion in the study as a comparator group. Exclusion Criteria: * Patients taking anticoagulants within 7 days prior to surgery. * Patients that are known to be pregnant at the time of surgery. * Patients are available for follow-up less than 18 months or do not undergo measurements within the scheduled period. * Patients with body mass index (BMI) greater than 50.0.
KORTUC Phase II - Intra-tumoural Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer
NCT03946202
Recruiting
Conditions Breast Cancer
Phase PHASE2
Enrollment 184
Locations 10 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

  • Hydrogen Peroxide

Primary Outcomes

  • Complete tumour response based on best response assessed by contrast enhanced MRI according to criteria outlined in Section 3.2.1 of the trial protocol, performed up to and including 12 months post radiotherapy
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2020-06-16
Completion: 2028-06-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 184 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Institute of Cancer Research, United Kingdom
Collaborators: Kortuc, Inc.
Principal Investigators:
  • Navita Somaiah (PRINCIPAL_INVESTIGATOR) - The Institute of Cancer Research & The Royal Marsden NHS Foundation Trust
Contact Information
Study Contact:
Lone Gothard
+44(0)2086613460
lone.gothard@icr.ac.uk
Justine Hughes
+44(0)2086613273
justine.hughes@icr.ac.uk
Interventions
  • Hydrogen Peroxide
Study Locations (10 sites)
Regional Cancer Centre (RCC), Trivandrum, Kerala 695011 India
Christian Medical Centre, Vellore, Tamil Nadu 632004 India
Tata Medical Centre, Kolkata, West Bengal 700160 India
Tata Memorial Centre, Mumbai, India
Royal Cornwall Hospitals NHS Trust, Truro, Cornwall TR1 3LJ United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, Scotland G12 0YN United Kingdom
Cambridge University Hospitals NHS Foundation Trust, Cambridge, CB2 0QQ United Kingdom
The Christie NHS Foundation Trust, Manchester, M20 4BX United Kingdom
University Hospitals of North Midlands NHS Trust, Stoke-on-Trent, ST4 6QG United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, SM2 5PT United Kingdom
Eligibility Criteria
Inclusion Criteria: * Patient age 18 years and over * Primary locally advanced breast cancer, or locally recurrent breast cancer with/without metastases (metastases, if present, should be stable or oligometastatic) * Radical/high dose palliative radiotherapy required for lifetime control of local morbidities * Patient physically and mentally fit for radical/high dose palliative radiotherapy * Target tumour accessible for intra-tumoural injection * Patient suitable/compliant with MR protocol * At least one tumour diameter ≥30 mm and ≤150 mm measurable by ultrasound or MR imaging * Patients with predicted life expectancy of 12 months or more * Negative pregnancy test before start of radiotherapy in women of child bearing potential and an ability/willingness to protect against pregnancy from consent and for 3 months post-radiotherapy * Patient offers written informed consent Exclusion Criteria: * Prior radiotherapy to the target area * Maximum diameter of target tumour \<30 mm or \>150mm measurable by ultrasound or MR * Anatomical location and/or extent of disease difficult to access for safe intra-tumoural drug injections, for example by virtue of contiguous major blood vessels and/or brachial plexus * Concomitant chemotherapy or biological therapy except Herceptin, Pertuzumab and Denosumab (all endocrine therapies and bisphosphonates are allowed concomitantly; other cytotoxics and biological therapies apart from those mentioned above should be stopped 3 weeks prior to RT) * Pregnancy or nursing * Hypersensitivity to any of the KORTUC ingredients
Restoration of Microbiota in Neonates
NCT03928431
Recruiting
Conditions Atopic Dermatitis, Atopic Asthma, Immuno...
Phase NA
Enrollment 300
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Maternal microbiota

Primary Outcomes

  • IgE-associated allergic 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: 2019-01-01
Completion: 2028-12-31
Eligibility
Age: 5 Minutes
Sex: ALL
Volunteers: false
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Karolinska Institutet
Collaborators: Uppsala University, Linkoeping University, Umeå University, Örebro University, Sweden, Jonkoping University
Principal Investigators:
  • Susanne Nylén, PhD (STUDY_CHAIR) - Dept Microbiology, Tumour and Cell Biology, Karolinska Institutet, Stockholm
Contact Information
Study Contact:
Lars G Engstrand, MD
+46706780318
lars.engstrand@ki.se
Marica C Hamsten, MSc
+46675555872
marica.hamsten@ki.se
Interventions
  • Maternal microbiota
Study Locations (1 sites)
Karolinska Institutet, Stockholm, Stockholm County 171 65 Sweden
Eligibility Criteria
Inclusion Criteria: * Infants of healthy mothers with uncomplicated pregnancies at term, mothers of any ethnic or social background that can speak, read, and understand Swedish to the extent that they can consent in Swedish. An additional inclusion criterion for mothers in the CS groups is vaginal pH ≤ 4 at the time of birth. Exclusion Criteria: * Infants of mothers with pre-eclampsia or complicated pregnancies, mothers \<18 years or \>40 years of age, genital herpes simplex, genital warts, HIV, Hepatitis B or complications during delivery, infants delivered prior to 37 weeks of gestation. Additional exclusion criteria for mothers in the CS group: Mothers positive to Group B Streptococcus, Group A Streptococcus, bacterial vaginosis, vaginal pH \> 4 at the time of birth. Mothers with fecal samples positive for Salmonella, Shigella, Campylobacter or Yersinia.
Establishment of Molecular Profiling for Individual Clinical Routine Treatment Decision in Early Breast Cancer
NCT03904173
Active, positions filled
Conditions Breast Cancer, Breast Neoplasms, Hormone...
Phase Not Applicable
Enrollment 2300
Locations 5 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Multi-parameter tests

Primary Outcomes

  • Treatment decision differences with or without Prosigna test
  • Distant recurrence-free interval
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: 2018-10-29
Completion: 2043-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 2300 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Oslo University Hospital
Collaborators: Klinbeforsk, Norwegian Cancer Society
Principal Investigators:
  • Bjørn Naume, MD PhD (STUDY_DIRECTOR) - Oslo University Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Multi-parameter tests
Study Locations (5 sites)
Haukeland University Hospital, Bergen, Bergen 5021 Norway
Drammen Hospital - Vestre Viken, Drammen, Buskerud 3004 Norway
Østfold Hospital, Sarpsborg, Kalnes 1714 Norway
Oslo University Hospital, Oslo, Oslo 0424 Norway
Telemark Hospital, Skien, Ulefossveien 55 3710 Norway
Eligibility Criteria
Inclusion Criteria: 1. Written informed consent (informed consent document approved by the Independent Ethics Committee \[IEC\]) obtained prior to any study-specific procedure 2. Female or male age ≥ 18 years 3. Able to comply with the protocol 4. Primary surgery completed or if re-resection needed, a change from pT1 to pT2 categorization is not expected 5. Histologically confirmed adenocarcinoma of the breast ≤ 5.0 cm in size (pT1-2) without metastasis to regional lymph nodes (pN0) or ≤ 20 mm in size (pT1) with lymph node micrometastases only (pN1mi) 6. Primary tumor concluded as hormone receptor positive (ER ≥ 1%), HER2 negative. Exclusion Criteria: 1. Metastasis to regional lymph nodes or distant sites/organs. 2. Previous treatment for localized breast cancer. Previous treatment for DCIS is allowed. 3. HER2 positive 4. ER and PgR negative tumor (\< 1% expression) 5. Other concomitant or earlier carcinoma less than five years prior to the breast cancer diagnosis, except for basal cell carcinoma and in situ cervix cancer 6. Use of or participation in intervention trials testing treatment with any investigational anti-cancer drug. Participation in other types of intervention trials is allowed (such participation needs to be registered). 7. Evidence of any other disease or condition that by the investigator is considered to impede follow-up of the patients.
Long-term Observation of Ophthalmic Changes in Patients With Obstructive Sleep Apnea
NCT03928665
Active, positions filled
Conditions Sleep Apnea, Glaucoma, Ocular Hypertensi...
Phase Not Applicable
Enrollment 150
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Perimetry changes over the years
  • Flicker defined form perimetry changes over the years
  • RareBit perimetry changes over the years
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: 2012-10-01
Completion: 2027-10-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: Not specified
Enrollment: 150 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Wroclaw Medical University
Collaborators: Wrocław University of Science and Technology
Principal Investigators:
  • Marta Misiuk-Hojło, Professor (STUDY_CHAIR) - Wroclaw Medical University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Study Locations (1 sites)
Department of Ophthalmology, Wroclaw, 50-556 Poland
Eligibility Criteria
Inclusion Criteria: * newly diagnosed obstructive sleep apnea indicated for positive airway pressure therapy, * ongoing treatment of sleep apnea with positive airway pressure therapy, * patients older than 18 years, * signed inform consent Exclusion Criteria: * pregnant and breastfeeding persons
Treatment Effects on Development of Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer
NCT03939481
Active, positions filled
Conditions Anatomic Stage I Breast Cancer AJCC v8, ...
Phase Not Applicable
Enrollment 1336
Locations 169 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Chemotherapy
  • Functional Assessment
  • Questionnaire Administration

Primary Outcomes

  • Number of Participants With Development of Peripheral Neuropathy
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: 2019-05-14
Completion: 2026-09-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 1336 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: SWOG Cancer Research Network
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Meghna S Trivedi (PRINCIPAL_INVESTIGATOR) - SWOG Cancer Research Network
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Chemotherapy
  • Functional Assessment
  • Questionnaire Administration
Study Locations (169 sites)
Kaiser Permanente-Deer Valley Medical Center, Antioch, California 94531 United States
Kaiser Permanente Dublin, Dublin, California 94568 United States
Kaiser Permanente-Fremont, Fremont, California 94538 United States
Kaiser Permanente-Fresno, Fresno, California 93720 United States
Kaiser Permanente-Oakland, Oakland, California 94611 United States
Desert Regional Medical Center, Palm Springs, California 92262 United States
Kaiser Permanente-San Francisco, San Francisco, California 94115 United States
Kaiser Permanente-Santa Teresa-San Jose, San Jose, California 95119 United States
Kaiser Permanente San Leandro, San Leandro, California 94577 United States
Kaiser San Rafael-Gallinas, San Rafael, California 94903 United States
Eligibility Criteria
Inclusion Criteria: * Patients must have stage I, II, or III primary non-small cell lung, primary breast, or primary ovarian cancer based on clinical or pathologic evaluation. Patients with Stage IV disease are not eligible. * Patients must be planning to start treatment with a taxane-based chemotherapy as part of one of the study-approved taxane regimens (docetaxel chemotherapy regimens for treatment of breast or ovarian cancer, or paclitaxel chemotherapy regimen for treatment of breast, non-small cell lung, or ovarian cancer) within 14 days after registration. (Note that docetaxel or paclitaxel may be administered with a non-neurotoxic chemotherapy, such as cyclophosphamide, and/or biologic agent, such as trastuzumab, and/or carboplatin. Additionally, nab-paclitaxel may not be substituted for paclitaxel for purposes of this study.) * Patients who will receive treatment in the setting of any other clinical trial are eligible as long as it is one of the study-approved regimens. Patients may receive additional treatments (i.e., experimental therapy, immunotherapy, biologics, etc.) as part of another clinical trial in addition to any regimen approved in this study. * Patients must not have received a taxane (paclitaxel, docetaxel, or protein-bound paclitaxel), platinum (cisplatin, carboplatin, or oxaliplatin), vinca alkaloid (vinblastine, vincristine, or vinorelbine), or bortezomib-based chemotherapy regimen prior to registration. (Note that while patients must not have received carboplatin in the past, patients may receive a carboplatin-containing regimen after registration as part of the docetaxel or paclitaxel regimen.) * Patients who can complete Patient-Reported Outcome (PRO) instruments in English or Spanish must: * Agree to complete PROs at all scheduled assessments * Complete the baseline PRO forms prior to registration * Patients with pre-existing neuropathy are eligible, including those with diabetes and neurological conditions such as multiple sclerosis or Parkinson?s disease. * Patients must agree to submit required specimens for defined translational medicine. * Patients must be offered the opportunity to submit additional optional specimens for future, unspecified translational medicine and banking. With patient?s consent, specimens must be submitted. * Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. * As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.