North Barrington

Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term gut conditions that cause symptoms like diarrhea, inflammation, bleeding, and belly pain. This research aims to see how many participants with UC or CD achieve remission, meaning their signs and symptoms disappear, after 14 weeks of treatment with Vedolizumab. This is a Phase 4 study evaluating the use of Vedolizumab in a community setting for moderate to severely active UC or CD. Participants will receive Vedolizumab treatment for about one year. During the first 6 weeks, the medication will be given through an intravenous infusion. After this period, treatment will continue with subcutaneous injections of Vedolizumab for the remaining weeks. If a participant's condition does not improve after 14 weeks, they will stop this treatment and may switch to another therapy. Additional visits are scheduled at 26 weeks and 52 weeks, with a follow-up assessment 18 weeks after the last dose. Throughout the study, participants will visit the clinic multiple times for monitoring. Researchers will assess remission using patient-reported outcome measures at week 14. Other evaluations include clinical checks and safety monitoring during treatment and after finishing the medication. The total study involvement can last over a year, including treatment and follow-up periods.

Researchers are evaluating a blood test based on circulating free-DNA (cfDNA) markers to improve early detection of colorectal cancer (CRC) and advanced precancerous lesions in the United States population. This study aims to optimize and finalize a panel of cfDNA markers by collecting blood samples and clinical data from different groups of participants related to colorectal cancer. The groups include newly diagnosed CRC patients scheduled for surgery but not yet treated, patients confirmed with CRC by colonoscopy who are not scheduled for surgery and are pre-treatment, and individuals at average risk for CRC undergoing routine colonoscopy screening. Participants will be enrolled into different arms based on their CRC status or screening plan. The study involves collecting blood samples and clinical data from these participants to evaluate the performance of the cfDNA assay. There are no investigational drugs or specific treatments administered during the study. The focus is on sample collection and marker assessment to finalize the blood-based test for use in the US population. Participants will undergo blood draws and provide clinical information related to their colorectal cancer diagnosis or screening status. The study monitors the development of the cfDNA assay and its baseline performance in detecting colorectal cancer markers. The total participation duration and follow-up details are not specified. Researchers will analyze the collected samples and data to optimize the marker panel for early CRC detection.

Researchers are evaluating the safety and performance of the Enhanced Lithotripsy System (ELS) to treat urinary stones. The study focuses on adults aged 21 and older who have a single urinary stone located in the ureter. The ELS aims to break urinary stones into small fragments that can pass with less or no discomfort, improving patient comfort compared to standard treatments. Participants will receive the ELS procedure, which uses low-pressure ultrasound combined with special microbubbles administered into the urine to fragment the stones. After the treatment, patients will be monitored for 30 days to check for the presence of stone fragments using a CT scan. If stones remain at Day 30, participants will have a follow-up evaluation at Day 60 to assess outcomes. During the study, researchers will track changes in pain, quality of life, and the time it takes for patients to return to normal daily activities or work. The total participant involvement includes the initial procedure and follow-up assessments over 30 to 60 days. This monitoring will help determine the treatment's safety and effectiveness in breaking down urinary stones.

This research aims to assess the safety and accuracy of the CapsoCam4 Colon (CV-3) endoscope system in detecting colonic polyps. It also evaluates how using artificial intelligence-based computer-aided detection (AI-based CADe) can improve the accuracy and speed of reading capsule videos. Colonoscopy results will be used as the standard for comparison. Participants will first prepare for and swallow the study capsule containing the investigational device. They will then prepare for and undergo a colonoscopy either the next day or within 3 to 6 weeks afterward. The study uses an open-label, prospective design to compare polyp detection between the capsule system and colonoscopy. During the study, participants will be monitored from capsule ingestion until colonoscopy results are available, up to 6 weeks. Researchers will measure how well the capsule detects polyps by comparing positive and negative percentage agreement with colonoscopy findings. Participants' safety and tolerance of the procedures will also be assessed throughout the study period.

Researchers are evaluating the safety and effectiveness of TARA-002, given directly into the bladder, in adults aged 18 years or older with high-grade non-muscle invasive bladder cancer, including carcinoma in situ (CIS) with or without Ta/T1. This Phase 2, open-label study focuses on participants who have active disease confirmed at their last tumor evaluation, enrolling them into two groups based on their prior exposure to BCG treatment. All participants receive six weekly doses of TARA-002 at a dose established in a previous Phase 1 study during the first treatment period. Those eligible for reinduction receive six more weekly doses in the second treatment period. Participants who achieve a complete response after the first treatment receive three additional weekly doses as maintenance during the second period. A third treatment period provides all eligible participants with three weekly doses at months 6, 9, 12, 15, and 18. Following treatment, participants enter a follow-up phase lasting from month 21 to month 60. During the study, researchers assess the occurrence of a high-grade complete response at any time from month 3 to month 60, including subgroup analyses for certain cohorts. Participants undergo pathology reviews to confirm response. The study monitors safety and efficacy throughout treatment and long-term follow-up, with evaluations designed to capture the duration and quality of the treatment response over several years.

Researchers are investigating the effectiveness of Saruparib (AZD5305) combined with a physician's choice of new hormonal agents (NHA) compared to a placebo plus NHA in men with metastatic castration-sensitive prostate cancer (mCSPC). This phase III study aims to demonstrate whether Saruparib plus NHA can improve radiographic progression-free survival (rPFS) in two groups of participants: those with homologous recombination repair mutations (HRRm) and those without (non-HRRm). About 1800 adult male participants with mCSPC will be divided into two cohorts based on their HRRm status. Each cohort will be randomized equally to receive either Saruparib orally with their chosen NHA or a placebo orally with the chosen NHA. The new hormonal agents may include abiraterone acetate, darolutamide, or enzalutamide. Participants will continue their assigned treatment and undergo regular tumor evaluation scans until their disease progresses or treatment is stopped for other reasons. Throughout the study, participants will have tumor tissue and blood samples collected to confirm HRRm status and monitor disease. They will be followed for survival until the study ends. An independent data monitoring committee will review safety and tolerability of Saruparib plus NHA. The main outcome measured is radiographic progression-free survival, tracked for up to approximately 50 months, to evaluate how well the treatments control cancer progression.

Researchers are evaluating the Shield blood test as a screening tool for colorectal cancer (CRC) in people aged 45 to 81 who are at average risk for CRC. This study aims to assess how well the Shield test performs during a second round of testing, using colonoscopy as the standard comparison. Colorectal cancer is a common and serious disease, especially in older adults, and early detection through screening can reduce mortality by catching cancer at earlier, more treatable stages. Participants will undergo the Shield blood test as part of their standard care. The study focuses on average-risk individuals who do not have symptoms or high-risk factors for CRC. The performance of the Shield test will be monitored over a period of 33 to 42 months after enrollment to evaluate its effectiveness compared to colonoscopy results. During the study, participants will follow study procedures and standard care assessments. Researchers will measure the performance of the Shield test in detecting colorectal cancer and its precursors during the second testing interval. This includes ongoing monitoring and data collection to understand the test's accuracy and reliability in a real-world setting, with a total follow-up period extending beyond two and a half years.

Researchers are evaluating the safety and initial antitumor effects of ORIC-944, an oral, selective small molecule inhibitor targeting the PRC2 complex, in patients with metastatic prostate cancer. The study is a first-in-human, open-label, multicenter phase 1/1b trial investigating ORIC-944 alone and combined with androgen receptor pathway inhibitors (ARPIs). The trial aims to establish safe dosing and explore preliminary effectiveness in this patient group. The study has three parts: Part I tests ORIC-944 alone through dose escalation; Part II combines ORIC-944 with ARPIs (such as abiraterone, apalutamide, darolutamide, or enzalutamide) to identify safe doses; Part III optimizes dosing for the combinations in two patient populations. Treatments are given orally and continuously, with different ARPI dosages depending on the drug used. The study evaluates two dose levels in combination with ARPIs to select the recommended phase 2 dose. Participants will undergo assessments including skin and tumor biopsies and regular monitoring of safety and drug levels. Researchers will measure pharmacokinetic outcomes like maximum plasma concentration and half-life, as well as clinical responses. The study includes follow-up to evaluate safety and preliminary antitumor activity over 12 months, with ongoing evaluation of drug exposure and effects.