Colorectal Cancer Clinical Trials

This is a two-part, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and anti- tumor activity of ETX-19477, a novel reversible small molecule inhibitor of PARG. Read Less

The purpose of this research is to determine whether a 16 week, home-based, aerobic and resistance exercise intervention will increase physical activity levels in Black and Hispanic breast, colorectal, or prostate cancer patients. The names of the study interventions involved in this study are: * Supervised aerobic and resistance exercise (SUP) - virtually supervised 16- week aerobic and resistance exercise performed at home via Zoom. * Unsupervised aerobic and resistance exercise (UNSUP) - home-based 16- week aerobic and resistance exercise. * Attention control (AC) - 16-week home-based stretching. Read Less

The purpose of this study is to evaluate the safety and clinical activity of cemiplimab and the combination of cemiplimab/fianlimab in microsatellite unstable localized or locally advanced colorectal cancer diagnosed in patients age 70 or greater. Read Less

This is a Phase 2 study to evaluate the efficacy of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous TIL and high-dose aldesleukin in patients with locally advanced, recurrent, or metastatic cancer associated with one of the following cancer types: 1.) gastric/esophagogastric, 2.) colorectal, 3.) pancreatic, 4.) sarcoma, 5.) mesothelioma, 6.) neuroendocrine, 7.) squamous cell cancer, 8.) Merkle cell, 9.) mismatch repair deficient and/or microsatellite unstable cancers, and 10.) patients who have exhausted conventional systemic therapy options by using the objective response rate (ORR). Read Less

This study aims to develop a highly sensitive, specific, and cost-effective blood assay for early detection of colorectal adenomas and cancer, using advanced machine learning and state-of-the-art biological analyses. Read Less

The primary objective of this study, DELFI-L101, is to train and test classifiers for lung cancer detection using the DELFI assay and other biomarker and clinical features. Read Less

The overall goal of this study is to develop a comprehensive, culturally tailored community-based colorectal cancer (CRC) prevention model with a dual emphasis on reducing CRC risk along with its CVD risk factors. The study intervention has two components: Screening, Brief Intervention, and Referral to Treatment (SBIRT) to address CRC screening and a web-based lifestyle program called "Alive!" to address CVD risk factors linked to CRC. The C.H.U.R.C.H. Trial (Community Health workers (CHW) United to Reduce Colorectal cancer and cardiovascular disease among people at Higher risk) has four specific aims: (1) to compare the effect of a CHW-Led SBIRT (Intervention) to Referral As Usual (RAU) (Usual Care) on guideline-concordant CRC screening uptake; (2) to evaluate the effect of a Culturally Adapted CHW-linked Alive! (CACA) program incorporated into the intervention arm on dietary inflammatory score (DIS); (3) to evaluate the effect of CACA on changes in Life Simple-7 (LS7) scores; and (4) to examine the multi-level contextual mechanisms and factors influencing CHW effectiveness, reach, and implementation of CRC screening uptake and CACA activities through a mixed-methods process evaluation. Given the broad reach and influence of Black churches, results from this study can be used to inform future scale up of this multi-pronged intervention. Read Less

Early detection by screening significantly reduces mortality from colorectal cancer (CRC). However, CRC screening rates have plateaued, with a considerable segment of the population remaining unscreened. Not being up to date with screening was associated with an approximate 3-fold risk for CRC-related mortality. There are different well-established CRC screening modalities, including invasive and non-invasive, which detect both polyps and cancer or cancer alone. Colonoscopy remains the dominant screening modality in the U.S.; however, colonoscopy uptake is low due to the invasiveness, perception of discomfort and embarrassment, logistical challenges, cost, and potential risks. Increasing patient compliance and adherence to screening is critical to improving CRC outcomes. A key to enhancing screening participation is patient acceptance of the testing method. A blood-based screening test presents an opportunity to overcome some challenging barriers. Blood-based tests are non-invasive compared to colonoscopy and can easily be part of a standard medical office appointment for a wellness check or scheduled visits to manage chronic illnesses and be completed at the point of care. This study will examine patient preference to use a blood-based screening test and compliance with CRC screening recommendations after failing to complete the FIT (Fecal Immunochemical Test)/FOBT (Fecal Occult Blood Test) or colonoscopy order in six months. Compliance with CRC screening is particularly poor among medically underserved populations, and most of these vulnerable individuals use federally qualified health centers (FQHCs) to obtain care. Implementing a blood-based screening test at FQHCs has the potential to improve CRC screening uptake and adherence and improve health disparities in medically underserved populations. This study seeks to answer the following four questions: 1) What is the acceptability of a blood-based screening as an alternative for patients who failed to complete a prior order using traditional screening methods? 2) Are patients who failed to comply with traditional screening methods more likely to comply with a blood-based screening test? 3) What is the effect of offering a blood-based screening test for patients who are non-compliance with traditional screening methods on overall CRC screening rates? 4) What are the facilitators and barriers to implementing the blood-based screening test in clinical settings? Read Less

skeletal muscle mass and function, is prevalent in up to 60% of colorectal cancer patients. This condition arises from a combination of factors such as aging, inactivity, treatment side effects, malnutrition, tumor burden, and inflammation. Given this complexity, singular interventions may not be sufficient to address sarcopenia in this group. Creatine monohydrate, a compound vital for energy during exercise, has been extensively researched and proven safe and effective across various demographics, including older adults and clinical populations. Studies show that creatine enhances benefits from resistance training, indicating potential to counter muscle mass and function decline post-cancer treatment. This study aims to assess the feasibilty of combining creatine supplementation with resistance training versus resistance training alone in sarcopenic colorectal cancer survivors. A randomized controlled pilot trial will compare a 10-week program of resistance exercise plus creatine (EXSUPP) with resistance exercise alone (EXPLA), each with 20 participants. Read Less

A Decentralized, Double-blinded, Randomized, 18 month, Parallel-group, Superiority Study to evaluate the impact of Complement Theory's Live 1:1 Exercise Coaching and Personalized Digital Application on Cancer Survivors' Cost of Care Read Less

This proposed Phase I clinical trial of SON-DP is an FIH, open-label, Phase Ia/Ib dose escalation and expansion study to evaluate the safety, tolerability, PK, and PD of SON-DP in participants with relapsed/refractory/intolerant to standard of care therapies, for advanced/ metastatic solid tumors. Read Less

ARGONAUT is a longitudinal, prospective, observational study that will enroll up to 5,000 advanced-stage cancer patients of diverse racial backgrounds to collect data used to develop precision microbiome medicines and for the identification of clinically actionable cancer-specific biomarkers to guide therapeutic decisions. Four types of solid tumor cancers will be profiled including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), colorectal cancer (CRC) and pancreatic cancer. Healthy control subjects without a cancer diagnosis will also be studied, comprised of individuals at high risk for CRC and healthy individuals at low risk for CRC. Risk assessment will be based on family history or past neoplastic findings during CRC screening. Data collected from this study will be used to develop the most effective new therapies, via microbiome optimization, all to the benefit of patients and the physicians treating them. Stool and blood samples will be collected longitudinally and analyzed to determine the impact of gut microbiome composition and function on the immune system and efficacy of the treatment. Currently enrolling the CRC, high risk, and low risk cohorts. Subjects who meet the entry criteria will provide up to 5 samples each of blood and stool over a 2-year period. Approximately 10%-20% of the subjects will provide colon tissue samples, either from research biopsies during Standard of Care (SOC) screening colonoscopy or retained surgical tissue from colectomy. Electronic health records will be obtained at various times for up to 8 years, to collect tumor imaging results and any other updated medical data, with no additional samples collected. In select cases, stool and blood samples will be collected beyond 2 years. Read Less