North Barrington

Researchers are evaluating the addition of Saruparib AZD5305 to standard radiation therapy RT and androgen deprivation therapy ADT for men with high-risk or very high-risk localized or locally advanced prostate cancer who have a BRCA1 or BRCA2 mutation. The study aims to determine if Saruparib improves metastases-free survival compared to placebo when added to these treatments. This phase 3 trial involves approximately 700 adult male participants. Participants are randomly assigned to receive either Saruparib or a matching placebo alongside physicians choice of ADT, with or without abiraterone and prednisoneprednisolone, depending on their cohort. Cohort A includes those receiving RT and continuous ADT, while Cohort B includes participants receiving RT, ADT, and abiraterone. Saruparib and placebo are administered orally. Treatment continues with close monitoring throughout the study. Participants will undergo scans including CT or MRI, bone scans, and PSMA-PET after their planned RT to confirm eligibility and monitor disease status. They will be followed for survival and disease progression for up to approximately 11 years. Researchers will assess metastasis-free survival, overall survival, prostate cancer-specific survival, biochemical recurrence, physical function, and urinary symptoms. Safety and drug levels will also be monitored. An independent committee will review safety and efficacy regularly throughout the trial.

Researchers are evaluating the use of Vedolizumab in adults with moderate to severely active Ulcerative Colitis UC or Crohns Disease CD, which are chronic gut conditions causing symptoms such as diarrhea, inflammation, bleeding, and abdominal pain. The study aims to measure how many participants achieve remission, meaning their symptoms disappear, after 14 weeks of treatment. This is a Phase 4 treatment study sponsored by Takeda, focusing on the effectiveness of Vedolizumab administered in a community setting. Participants with either UC or CD will receive Vedolizumab intravenously IV during the first 6 weeks, with doses given at Weeks 0 and 2, and possibly an additional IV dose at Week 6. After this initial period, participants may switch to subcutaneous under the skin injections of Vedolizumab every two weeks from Week 6 until Week 50. If the treatment does not appear effective by Week 14, participants may stop Vedolizumab and switch to another therapy. Additional required visits occur at 26 weeks and 52 weeks, with a final check 18 weeks after the last Vedolizumab dose. Throughout the study, participants will visit the clinic multiple times for treatment and monitoring. Assessments include patient-reported symptom measures at Weeks 6, 14, and 52, clinical response evaluations, and endoscopic examinations to observe mucosal healing. Blood and stool tests will measure inflammation markers like C-reactive protein and fecal calprotectin. Safety monitoring will track serious infections up to 72 weeks. Overall, participants are involved for about one year of treatment plus follow-up to evaluate the long-term effects of Vedolizumab.

Researchers are conducting an observational study to evaluate and optimize a blood test that detects colorectal cancer CRC by analyzing circulating free DNA cfDNA markers. This test focuses on detecting advanced precancerous lesions and early CRC in the United States population. The study aims to improve the performance of this blood-based assay for early CRC detection by collecting blood samples and clinical data from different participant groups. Participants include newly diagnosed CRC patients scheduled for surgery but not yet treated, patients confirmed with CRC by colonoscopy but not scheduled for surgery, and individuals at average risk undergoing routine colonoscopy screening. Blood samples and clinical information will be collected prospectively from these groups to support assay development and machine learning model training. During the study, participants will provide blood samples and clinical data before any cancer treatment. Researchers will analyze these samples to develop and validate the blood test. The study includes baseline assessment for assay development and ongoing machine learning training extending up to 24 months after the last participants involvement. Participants may be monitored for clinical data and sample collection over this period to support assay evaluation and optimization.

This research aims to evaluate the safety and performance of the Enhanced Lithotripsy System ELS for treating urinary stones in adults. The study focuses on patients aged 21 or older who have a single urinary stone in the ureter. The purpose is to assess how well the ELS can break stones into small fragments that can pass more easily, potentially reducing discomfort. Participants will receive the ELS procedure, which uses low pressure ultrasound combined with microbubbles to pit and fragment the urinary stones. All participants undergo this experimental procedure, and no placebo or comparison group is involved. The study includes follow-up evaluations at 30 days and, if necessary, at 60 days to check for remaining stone fragments via CT scans. During the study, participants will be monitored for stone presence using CT imaging and assessed for changes in pain levels, quality of life, and return to normal daily activities and work. Safety and effectiveness will be evaluated up to 30 days after treatment, with an additional assessment at 60 days if stones remain. The total study duration extends from the procedure through these follow-up periods.

Researchers are evaluating the safety and effectiveness of the CapsoCam4 Colon CV-3 endoscope system in detecting colonic polyps. This study aims to determine whether the AI-based computer-aided detection CADe feature improves the accuracy and efficiency of reading capsule videos. Colonoscopy results will be used as the reference standard to compare findings from the capsule system. Participants will prepare for and swallow the study capsule, which includes a new second-generation design. After the capsule procedure, participants will undergo a colonoscopy either the following day or between 3 to 6 weeks later. This allows researchers to compare the capsule findings with the colonoscopy results. During the study, participants will be monitored from the time of the capsule swallow up to the colonoscopy within 6 weeks. The main outcomes measured include the positive and negative percentage agreement between the capsule system and the colonoscopy in detecting polyps. Participants will complete required preparation and procedures, and safety and effectiveness data will be collected throughout the study period.

Researchers are studying the safety and effectiveness of TARA-002, a biological preparation containing Streptococcus pyogenes cells, for adults aged 18 and older with high-grade non-muscle invasive bladder cancer NMIBC, including carcinoma in situ CIS with or without TaT1 tumors. This Phase 2 open-label trial further evaluates TARA-002 at a dose established in an earlier Phase 1a study. Participants include those with active disease confirmed within 3 months before enrollment, divided into two groups based on prior treatment with BCG therapy. Participants receive TARA-002 directly into the bladder through instillation. The treatment involves an initial period of six weekly doses, followed by a possible second period of six additional weekly doses or three weekly maintenance doses for those with a complete response. Maintenance doses continue at specified months up to 24 months. After treatment, participants enter a follow-up period lasting from month 27 to month 60 to monitor long-term outcomes. Throughout the study, participants undergo regular assessments including evaluations of tumor response, progression-free survival, overall survival, and quality of life using specific questionnaires. Researchers monitor urinary biomarkers and track adverse events from the first day of treatment through the entire follow-up period. The studys main outcome is the rate of high-grade complete response measured from 3 to 60 months after treatment. Total participation may last up to 5 years.

This research aims to evaluate the Shield blood tests performance for colorectal cancer CRC screening in people aged 45 to 81 who are at average risk for CRC. The study focuses on assessing the test during a second round of screening, using colonoscopy as the reference standard. CRC is a common and serious disease, especially affecting older adults and certain minority groups, with early detection being key to improving outcomes. Participants will undergo the Shield blood test as part of their routine standard care, and their results will be compared to colonoscopy findings. This study is observational and collects real-world evidence over a period of 33 to 42 months after enrollment to assess how well the Shield test performs in detecting CRC or its precursors during the second screening interval. Participants will be involved in scheduled study procedures and standard care assessments, with data collected on the tests accuracy and effectiveness over time. The main outcome measured is the performance of the Shield test during the second testing period. The study will continue until December 2030, monitoring participants to gather long-term information about CRC screening efficacy in an average-risk population.

Researchers are evaluating ORIC-944, a selective small molecule inhibitor targeting PRC2, in patients with metastatic prostate cancer. This open-label, phase 11b study aims to establish the safety and preliminary antitumor activity of ORIC-944 both alone and combined with androgen receptor pathway inhibitors ARPIs. The study involves patients who have progressed after prior ARPI therapies and explores dose escalation and optimization across different patient groups. Participants receive ORIC-944 orally once daily in 28-day continuous cycles either alone or combined with ARPIs such as abiraterone, apalutamide, darolutamide, or enzalutamide. The study has three parts Part I tests ORIC-944 alone Part II tests combinations with ARPIs Part III optimizes dosing of ORIC-944 with ARPIs in separate cohorts. Future combinations with abiraterone or enzalutamide may also be explored. During the study, participants undergo assessments including skin and tumor biopsies and monitoring of organ function and performance status. Researchers measure drug concentrations in the blood, antitumor responses, progression-free survival, and PSA levels. Safety and activity are evaluated over months, with follow-up for up to 36 months. The trial is sponsored by ORIC Pharmaceuticals and runs from 2022 to 2028.