Dublin

Researchers are evaluating a blood-based test called the Episwitch CiRT4, which maps 3D genome conformation, to predict how patients with stage III and IV cancer will respond to PD-(L)-1 immune checkpoint inhibitors. This test provides a binary likelihood of response (high vs. low probability) and aims to compare these predictions with actual treatment outcomes across multiple cancer types. The study also explores the relationship between social factors and test results or patient outcomes. Patients eligible for immune checkpoint inhibitor therapy will be offered the Episwitch CiRT4 test before starting treatment or while already receiving it. Those predicted to have a high probability of response will have repeat testing every three months. Participants will be followed for up to six months, during which treatment details and clinical outcomes such as disease-free survival, overall survival, stable disease, progressive disease, complete response, and time to recurrence will be collected. Throughout the study, researchers will gather comprehensive data on social determinants of health to analyze any connections to response likelihood or resistance. They will also collect physician questionnaires and patient-reported outcomes. The main outcomes include correlating the test's low probability predictions with actual responses, evaluating potential cost savings from avoiding ineffective therapies based on test results, and examining social factors influencing outcomes, all tracked from enrollment through the 24-week follow-up.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of two different dose levels of solrikitug compared to placebo in people with Chronic Obstructive Pulmonary Disease (COPD). This Phase 2 study includes participants who have had COPD for at least 12 months and have elevated blood eosinophil levels. The trial aims to understand how solrikitug affects blood eosinophil counts and other health measures related to COPD. Participants will be randomly assigned to receive either low-dose solrikitug, high-dose solrikitug, or a placebo. These treatments are given by subcutaneous injection at the study site over a 12-week period. After treatment, there is a 16-week follow-up period to monitor participants for any lasting effects or safety concerns. During the study, participants will have regular assessments including lung function tests, blood tests to measure eosinophil counts, and evaluations of COPD symptoms. Researchers will monitor safety and tolerability closely throughout the treatment and follow-up periods. The total time commitment for participants covers the 12 weeks of treatment plus the 16 weeks of follow-up, totaling 28 weeks.

Researchers are establishing the Caris Biorepository to collect and store high-quality biological specimens along with clinical and demographic data. This resource aims to support research studies focused on advancing precision medicine and improving patient care, especially in areas related to cancer, early detection of cancer, and minimal residual disease. The biorepository is designed to securely share valuable biospecimen information and clinical outcomes to help develop targeted treatments and improve healthcare. The Caris Biorepository will gather specimens prospectively from multiple sources and maintain molecular integrity and clinical relevance of these samples. It will provide access to this information for researchers both within Caris Life Sciences and external collaborators such as government agencies, academic institutions, and industry partners. The project supports drug development, clinical research trials, publications, and healthcare policy development by bridging the gap between human specimens and associated clinical data. Participants in this research will provide biospecimens and clinical data, with the biorepository managing access and use of these materials over time. The study focuses on developing a high-quality collection of human samples and associated data for up to 35 years, supporting various research purposes. Outcomes include ensuring specimen integrity and releasing specimens for testing while maintaining detailed clinical information to facilitate future medical discoveries and improvements in patient outcomes.

Researchers are studying Veterans with alcohol use disorder (AUD), a condition affecting 1 in 10 Veterans, to find better ways to help them reduce heavy drinking. The study compares the effects of medications approved for AUD with or without the addition of a smartphone app called Stand Down (SD-App) designed to help manage drinking. The goal is to see if combining the app with medications in primary care improves drinking outcomes, mental health, and treatment adherence compared to medications alone, and to understand how to implement this approach across VA healthcare. Participants will be randomly assigned to receive either medication-assisted treatment for AUD (MAUD) plus access to the SD-App, or MAUD alone. The SD-App uses motivational and cognitive-behavioral strategies organized into modules to raise awareness of drinking, set goals, manage cravings, and connect to support. Medications prescribed include naltrexone, disulfiram, acamprosate, or topiramate, as decided by the clinical prescriber. The study will enroll 330 Veterans ages 18 to 80 who are starting MAUD and have a smartphone. Veterans will be assessed at the start of the study, and again at 3, 6, and 12 months, through questionnaires and medical record reviews to measure changes in heavy drinking days and other alcohol-related outcomes. Qualitative interviews will also gather feedback from Veterans, pharmacists, and clinical leaders about using the SD-App with medications in primary care. The total participation time spans one year, with the main effectiveness outcomes measured at 6 months post-baseline.

Researchers are evaluating the performance of two new blood-based tests designed to help detect cancer in adults aged 45 and older who show symptoms or signs that suggest cancer might be present. These tests focus on multiple cancers, including those in the gastrointestinal system, to improve early diagnosis and guide further medical evaluation. Participants will have up to 40 mL of blood collected for analysis with the investigational diagnostic tests. For those suspected of having cancer, standard diagnostic procedures will be followed to confirm the diagnosis, while participants already diagnosed with cancer must not have started treatment prior to enrollment. The results of the investigational tests will be kept confidential and will not influence clinical care decisions, ensuring unbiased evaluation. During the 18 months following enrollment, researchers will assess the accuracy and performance of these diagnostic tests by comparing their results with clinical diagnoses confirmed through standard care. Participants may undergo routine clinical evaluations, imaging, and pathology reviews as part of their care. The study team will monitor outcomes and maintain blinding to test results to ensure objective assessment throughout the study period.