Dublin

Researchers are evaluating a blood-based test called Episwitch CiRT4 to see if it can predict how patients with stage III or IV cancer will respond to immune checkpoint inhibitor ICI treatments, specifically PD-L-1 inhibitors. This observational study aims to compare test predictions with actual patient responses across different types of cancer. The study also explores how social factors might relate to treatment responses and outcomes. Patients who are candidates for or currently receiving ICI therapy will undergo the Episwitch CiRT4 test before starting or during treatment. If the test indicates a high likelihood of response, repeat testing will occur every three months. Participants will be followed for six months to collect data on treatment administered, disease progression, survival, and patient-reported outcomes, along with social determinants of health. Throughout the study, researchers will gather clinical information, including physician questionnaires and patient feedback, to assess outcomes such as disease-free survival and time to recurrence. The study will also analyze health economics related to the tests potential to reduce unnecessary ICI treatments. Monitoring will continue for 24 weeks, with comprehensive data collection to evaluate the correlation between test results, social factors, and patient outcomes.

Researchers are studying the Caris Biorepository, a project designed to collect and store high-quality biological specimens and related clinical data to support research aimed at advancing precision medicine and improving patient care. This observational study focuses on gathering samples and information from various sources, including healthy individuals and cancer patients, to help understand disease treatments and clinical outcomes. The biorepository includes samples from different donor groups, such as those with no disease, treatment-nave patients with new solid tumors, individuals at higher risk for cancer, patients with advanced cancer, and those with a history of cancer but no active disease. The project aims to maintain molecular integrity and clinical relevance of these specimens while providing access to researchers and collaborators for drug development, clinical trials, and healthcare policy enhancements. Participants provide informed consent and contribute biological samples and clinical data that are securely stored and shared for research purposes. The study measures include ensuring specimen quality and relevance over 35 years and facilitating specimen release for testing. Laboratory testing will be conducted throughout the study duration. The project supports long-term research collaboration and aims to impact patient outcomes and treatment practices over time.

Researchers are evaluating whether combining medications for alcohol use disorder MAUD with a smartphone app called Stand Down SD-App can improve drinking outcomes for Veterans diagnosed with alcohol use disorder AUD compared to medications alone. This study addresses barriers Veterans face in accessing psychosocial treatments, such as stigma and distance from clinics, by offering an app-based intervention alongside medication in primary care settings. The trial aims to inform how to spread this app across VA facilities nationally. Participants will be randomly assigned to receive either standard MAUD care or MAUD plus access to the Stand Down app. MAUD includes medications like naltrexone, disulfiram, acamprosate, and topiramate, prescribed by VA clinical providers as usual care. The Stand Down app helps users manage alcohol use through personalized strategies, self-monitoring, and support tools, delivered via their smartphones. The study will enroll 330 Veterans across 15 VA sites and follow them for up to 12 months. Throughout the study, participants will complete assessments at baseline, 3, 6, and 12 months, including self-reports and medical record reviews to measure heavy drinking days, alcohol-related problems, risk levels, mental health symptoms, and treatment adherence. Researchers will also conduct interviews with Veterans and VA staff to explore factors affecting the apps adoption and use. The total study participation may last up to one year with ongoing monitoring of drinking behaviors and health outcomes.

Researchers are evaluating the performance of two blood-based diagnostic tests designed to help detect cancer in individuals aged 45 and older who show symptoms, signs, or findings that suggest cancer. The study aims to assess these tests in people suspected of having cancer or those recently diagnosed but not yet treated. This observational study is sponsored by Harbinger Health and focuses on cancers originating from specific sites outlined in the study protocol. Participants will provide a blood sample of up to 40 mL collected in special tubes for analysis by the investigational diagnostic tests. Those with suspected cancer will undergo a standard diagnostic work-up to confirm if cancer is present, while those already diagnosed must be treatment-nave. The results of the diagnostic tests will not be shared with patients or doctors and will not influence clinical decisions. All testing and analyses are conducted in a blinded manner. During the study, participants will complete a blood draw and follow the usual diagnostic procedures as needed. Researchers will track clinical outcomes, diagnostic test performance, and cancer incidence over 18 months. The main measure is how well the two diagnostic tests identify cancer among participants showing relevant symptoms or signs. Safety and adherence will be monitored, but the study does not involve treatment. Total participation duration may vary depending on diagnostic and follow-up processes.