Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-09-17
Completion: 2027-01-01
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The purpose of the study is to determine the effectiveness of wild blueberries on cardiovascular health, cognitive function, and gut microbiota composition in non-Hispanic Black and White adults with elevated blood pressure.
The study will primarily evaluate safety of the KNP-1000 apheresis system for pregnant women and their fetuses diagnosed with preeclampsia with severe features between 23- and 32-weeks' gestation (very preterm).
The objective of this study is to assess two novel positron emission tomography (PET) radiotracers, \[64Cu\]CM500 and \[68Ga\]CM500, for Positron Emission Tomography-Magnetic Resonance Imaging (PET-MR) and Positron Emission Tomography / Computed Tomography (PET-CT) imaging of solid tumors. These tracers have the potential to detect solid tumors throughout the body and may enable doctors to identify smaller tumors than conventional imaging techniques.
The PRIMROSE CSF Study aims to study cerebrospinal fluid (CSF) in patients with breast cancer that has spread to the brain (brain metastasis) or the lining surrounding the brain (leptomeningeal disease). Research into breast cancer that has spread to the brain or the lining of the brain is limited due to difficulty in obtaining brain tissue containing cancer cells. Such tissue is typically only available when tumours are removed, which does not occur in all patients. Evidence indicates an increasing number of patients with breast cancer are developing disease that spreads to the brain or the lining of the brain as treatments improve. The PRIMROSE CSF Study aims to improve understanding of breast cancers that spread to the brain or brain lining by collecting and analysing the fluid that circulates around the brain and comparing these samples with other cancer and blood samples. Cancer cells that have spread to the brain or its lining shed genetic material into the surrounding fluid. Collection of this fluid enables purification of genetic material released by breast cancer cells. This approach allows examination of the genetic profile of breast cancer cells affecting the brain or its lining without the need for surgery. Differences between the original cancer and metastatic disease in the brain can then be analysed. This research will support improved understanding of why certain breast cancers spread to the brain and contribute to the development of new treatments for breast cancer that has spread to the brain or the lining of the brain.
The primary goal is to conduct a pilot evaluation of the Amma device, to determine whether it is feasible to offer as an option for patients within oncology suites within the PH\&S system.
The overall objective of this COBRE pilot project is to enhance the design of a 3-arm cluster randomized trial that will test the efficacy and mechanism of effect of the MyMammogram DA with or without a provider communication intervention. This will be accomplished through two aims: (1) Refine, with community partner input, a clinical trial protocol to optimize engagement among patients and primary care providers (PCPs) practicing in rural settings. In consultation with patients, PCPs, and informatics experts, the study team will refine site selection, randomization, patient and PCP recruitment, and data collection protocols to meet the needs of the rural health care delivery system and participants. The result of this aim will be a modified protocol and intervention strategy that is acceptable to partners. (2) Adapt and test trial and intervention implementation features to achieve protocol acceptance and adherence. The investigators will pilot the adapted three-arm randomized trial protocol in rural primary care settings that compares the MyMammogram DA with or without a risk summary provided to the PCP pre-visit, relative to usual care. Implementing the trial in two phases (n=15 each) will systematically identify barriers and facilitators to trial participation to refine protocols. Participants will receive acceptability surveys and investigators will conduct qualitative interviews with patients and PCPs to understand experiences with trial implementation from multiple perspectives.
Prospective, multi-center, randomized, open label comparative Phase III study in patients with intermediate to high-risk (as defined in the SURVIVE trial) HER2-positive or HER2-low early breast cancer, who participate in the SURVIVE trial and experience a molecular relapse, as assessed based on a positive circulating tumor DNA (ctDNA) result, with 2:1 allocation to: * Arm A: Trastuzumab-Deruxtecan (i.v. 5,4 mg/kg, q3w) + endocrine therapy (if hormonal-receptor-positive) for 16 cycles or until relapse, if earlier * Arm B: Continuous treatment of physician's choice (may include endocrine treatment, CDK4/6-Inhibition, T-DM1, Olaparib, Trastuzumab, Pertuzumab, Capecitabine or Neratinib)
This is a phase I clinical trial to determine the maximum tolerated dose (MTD) of KK-LC-1 TCR-T cells for the treatment of metastatic cancers that express KK-LC-1. Participants will receive a conditioning regimen, KK-LC-1 TCR-T cells, and aldesleukin. The safety profile and clinical response to treatment will be determined.
The main purpose of the project is to validate patient reported outcomes measures (PROMs) in reconstructive breast surgery. BREAST-Q will be evaluated for Swedish and Sweden.Hospital Anxiety and Depression Scale (HADS), EuroQol 5D (EQ5D), and SF-36 will be validated for reconstructive breast surgery. In addition, the complication classification system according to Clavien-Dindo will be validated for reconstructive breast surgery.
This is a randomized, controlled study to assess the effect of Sidekick Health's digital program on self-efficacy and medication adherence in breast cancer patients prescribed adjuvant anti-hormonal treatment. Participants will be treated with the digital program in addition to standard of care (SoC), or SoC only.
The goal of this real-world study (RWS) is to evaluate the effectiveness of Trop-2 ADC (sacituzumab govitecan) in treating breast cancer patients with brain metastases, and to understand the safety profile of this drug in real clinical practice across multiple centers. The main questions it aims to answer are: Does Trop-2 ADC (sacituzumab govitecan) improve intracranial outcomes in breast cancer patients with brain metastases (e.g., intracranial objective response rate, intracranial progression-free survival)? What types and rates of adverse events do breast cancer patients with brain metastases experience when receiving Trop-2 ADC (sacituzumab govitecan)? This is a multicenter real-world study, which will collect and analyze data from breast cancer patients with brain metastases who have received Trop-2 ADC (sacituzumab govitecan) in routine clinical care (no randomization or placebo control, consistent with real-world clinical scenarios). Participants (breast cancer patients with brain metastases who received Trop-2 ADC) will have their data collected from: Electronic health records (EHRs) across multiple medical centers Regular clinical follow-up visits (e.g., once every 4-8 weeks) for imaging assessments (to evaluate brain metastasis changes) and safety monitoring Medical records documenting treatment responses, disease progression, and any adverse events during treatment and follow-up
Primary Objective: 1\) To examine the impact of Circulating tumor DNA (ctDNA) (expressed as mean tumor molecules per ml) on treatment decision making in patients with early stage breast cancer after neoadjuvant therapy and surgery Secondary Objectives: 1. Understand ctNDA kinetics in the neoadjuvant and adjuvant setting 2. To identify any associations between clinical staging and measurable ctDNA
This Phase 1, multi-center, open-label, dose escalation and dose optimization study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and preliminary clinical activity of MOMA-313 administered orally as a single agent or combination therapy in patients with homologous recombinant deficient solid tumors.
This study evaluates the efficacy and safety of camrelizumab, apatinib, and eribulin versus physician's choice chemotherapy in advanced TNBC.Primary Objectives: Assess improvements in progression-free survival (PFS) and overall survival (OS).Secondary Objectives: Compare objective response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR), duration of response (DoR), time to response (TTR), two-year OS rate, biomarker analysis, and quality of life (QoL).Safety: Assess and compare adverse event incidence and severity.
This clinical trial studies the effect of standard verbal counseling with or without a pictorial educational tool for the reduction of psychological morbidity in patients with stage 0-IIIA breast cancer receiving radiation therapy. Beginning radiation therapy for breast cancer can be stressful. Education about what to expect often reduces the stress, anxiety, and depression experienced by these patients. This study is being done to see how effective photos are in reducing stress, anxiety, and depression associated with radiation therapy for patients with breast cancer.
Breast Cancer (BC) is the primary oncological diagnosis in women, with the annual incidence expected to exceed 3 million new cases by 2040 due to population growth and aging. During the COVID-19 pandemic, novel methods were adopted worldwide to provide continuous patient care, including telehealth, fast-track protocols such as awake surgery in breast cancer. These innovative techniques allowed for improved access to care, and additionally reduced emissions with environmental impact, better resource utilization, and improved continuity of care, but their impact post-pandemic era has not been investigated. A current issue is the environmental impact of hospitals, particularly operating rooms, as it has been analysed that 25-30% of hospital waste comes from these areas. A Breast Green Surgery protocol (BuGS protocol) has been designed to reduce Breast Surgery Impact of care, evaluating for the synergistic effect of different procedure for the first time on classic Clincal Outcome, Patients' Reported Outcome Measure (PROM), and Environment Related Outcome Measure (EROM) in breast cancer surgery. Main hypothesis is that BuGs protocol will provide a significant reduction in carbon footprint of care (EROM) without impacting clinical outcome and PROMs.
This is a prospective, multi-center, open-label, exploratory diagnostic phase II imaging trial for patients with metastatic breast cancer with at least one line of systemic therapy. The overarching aim of the HER2-Ex PET trial is to study the role of precision imaging utilizing positron emission tomography (PET) with the HER2-specific tracer \[68Ga\]Ga-ABY-025 (hereafter referred to as HER2-PET) in enhancing treatment planning for patients with metastatic HER2-expressing breast cancer Patients will be allocated based on HER2-status on PET and biopsy. Patients with HER2-expressing lesions in a fresh or archived tumour biopsy will be treated with T-DXd. The study hypothesis is that PET/CT precision imaging with a contemporary HER2-radiotracer (\[68Ga\]Ga-ABY-025) can be used and can lead to a potentially better identification of patients who benefit from T-DXd treatment, thereby achieving improved treatment responses as well as fewer side effects. This study's diagnostic approach provides a more individualized treatment strategy. Additionally, this study can potentially give us a better biological understanding of HER2-expressing mBC.
Based on the high expression of specific receptors on the surface of diseased tissues and neovascularization, noninvasive targeted molecular imaging can be used to visualize lesions in vitro by combining specific ligands labeled with short half-life isotopes. In this study, a novel dual-target imaging agent 68Ga-RM26-RGD was used for clinical study of tumor PET/CT imaging to further verify its clinical application value.
The aim of this study is to establish organoid cultures, which are three-dimensional in vitro tumor models capable of supporting the long-term ex vivo growth of tumor cells derived from patients with breast carcinoma. These organoids will be used for the isolation of extracellular vesicles (EVs), which are naturally released by cells and have the ability to selectively recognize tumor tissue. Due to these properties, EVs represent promising vectors for the targeted delivery of diagnostic agents, with potential applications in fluorescence-guided surgery.
The JAZMINE study is a multicenter, open-label, non-comparative, phase Ib/II clinical trial to evaluate safety and preliminary efficacy of zanidatamab in combination with tucatinib and chemotherapy (capecitabine or eribulin mesylate) in HER2-positive advanced breast cancer.