Clinical Research Directory

Pathways, Risk Factors, and mOleculeS to Prevent Early-onset Colorectal Tumors

This research study is an open-label Phase 1 Exploratory/Pilot clinical trial to measure the effects of the incretin mimetic, tirzepatide, on tissue, urine, blood, and microbiome biomarkers associated with colorectal cancer risk and to understand the feasibility of this precision prevention trial approach for a future larger study.

BILe Acid-gut Microbiome Axis MODification Through Diet Education for Colorectal Cancer Prevention

This research study is a prospective, single-arm clinical trial to assess the effect of a dietary intervention for more plant-based and less animal-based food intake on secondary bile acid production, gut microbiota, circulating biomarkers and gene expression associated with colonic bile acid receptor activation and colorectal cancer.

Study Comparing the Quality of Colon Cleanliness With Prepackaged LRD (Low-residue Diet) vs. Guided (POG).

Low-residue diet (LRD) in patient improves the quality of the colon cleanliness and thus the adenoma detection rate (ADR). This is a key criterion in colonoscopy screening for colorectal cancer (CRC). The benefit of an LRD lasting more than 24 hours before colonoscopy has not been demonstrated compared to a 24-hour LRD. Few studies have evaluated the benefit of a prepackaged 24-hour LRD compared to simply receiving oral and written LRD instructions during a consultation. The aim of the study is to evaluate the usefulness of a prepackaged LRD (Colobox®) compared to simple LRD instructions on colon cleanliness (Boston score) in patients examined by endoscopy.

Colorectal Cancer Prevention Research Study: Eat Right, Screen Right

The Eat Right, Screen Right Extension program aims to help adult learners manage nutrition risks and screening options for colorectal cancer prevention. Participants navigate through 6 tailored lessons covering user-identified, evidence-based information relevant to reducing colorectal cancer risk. First, participants receive an overview of colorectal cancer screening guidelines (e.g., age, modalities), personalized nutrition risk factors (e.g., how their intake of red meat, processed meat, and alcohol aligns with nutrition guidelines for colorectal cancer prevention), and additional optional colorectal cancer prevention topics via a branched conversational pathway selected by the participant. Subsequently, participants also have the opportunity to access five additional modules, providing more in-depth information. Self-reported outcomes include changes in cancer information overload, dietary intentions, and cancer screening intentions. This is an extension of previously funded pilot study and aims to enhance reach by leveraging the UF/IFAS Extension infrastructure allowing participants to achieve the following goals: (1) demonstrate accurate understanding of the modifiable dietary behavior that decrease colorectal cancer risk, (2) demonstrate understanding of screening guidelines and several ways to screen for colorectal cancer (e.g., home stool tests, colonoscopy, others), (3) develop confidence to obtain colorectal cancer screening and stay up to date with screening based on guidelines, (4) apply behavior change strategies to support cancer prevention behaviors.

ULTRA-high-risk Surveillance to Avoid Future Events: the ULTRA-SAFE Trial

The ULTRA-SAFE clinical trial is a prospective, randomized study designed to address the limitations of current "one-size-fits-all" colorectal cancer surveillance guidelines. While international standards recommend a three-year follow-up colonoscopy for all high-risk patients, data suggests that those with multiple advanced adenomas face a significantly higher recurrence risk (20%) compared to those with only low-risk adenomas (9%). To provide more personalized care, the trial compares a Standard Arm (colonoscopy at year three) against a FIT Arm, where participants undergo annual fecal immunochemical testing in years one and two. A positive FIT triggers an earlier colonoscopy, with the goal of reducing the 3-year prevalence of metachronous advanced colorectal neoplasms (meta-ACRN) from 20% to approximately 12.7%. The study has enrolled roughly 940 participants to statistically validate whether this early screening intervention can effectively prevent future malignant events in ultra-high-risk populations.

Prophylactic Properties of Carrot Juice in Patients With High-Risk Colorectal Polyps

The goal of this prospective randomized double-blinded bi-national study is to test the prophylactic effect of polyacetylenes from carrots on the population of patients who had a resection of high-risk adenomas of the large bowel. The main question it aims to answer is: Will carrot juice rich in polyacetylenes inhibit neoplastic transformation and growth in high-risk humans? Participants will have to drink 100 ml of juice daily after the adenoma resection for 1 year and keep a simple diary/calendar. Researchers will compare the group with ingestion of Falcarinol (FaOH) / Falcarindiol (FaDOH) rich carrot juice versus the group consuming placebo juice, to see if the polyacetylenes significantly reduces neoplastic transformation and growth in high-risk patients.

The Beans to Enrich the Gut Microbiome vs. Obesity's Negative Effects (BE GONE) Trial

You are being asked to take part in this study because either you are a survivor who has a previous history of colorectal cancer or an MD Anderson patient who had a precancerous colorectal polyp or you have a previous history of colorectal cancer, and you have a current adult body mass index (BMI) score of 25 or higher. The BMI score is used as an indicator of the level of body fat, based on height and weight. The goal of this clinical research study is to learn if eating canned, pre-cooked beans can help improve the levels of healthy bacteria in the digestive system and reduce the effects of obesity on cancer risk. This is an investigational study. Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.

The Food Environment, Microbial Cysteine Metabolism, and Cancer Disparities

The goal of this clinical trial is to learn if changing cysteine levels in the diet can influence how the body processes cysteine in Black and White individuals aged 45-75 with a history of non-cancerous polyps. The main questions it aims to answer are: * At the beginning of the study, do Black participants have higher levels of cortisol (a stress hormone) and compounds made from cysteine in their blood when compared to White participants? * Does eating less cysteine lower the body's natural cysteine activity and lead to less gut bacteria that break down cysteine? * Does eating less cysteine lead to less inflammation in the gut and lower levels of markers of inflammation in the blood? Research will compare a high cysteine diet and a low cysteine diet, and each participant will eat both diets. Participants will be in the study for 11 weeks and 2 days. Over the course of the study, participants will: * Eat a high cysteine diet for 3 weeks, and a low cysteine diet for 3 weeks * Eat a moderate cysteine diet for 1 week before each study diet * Complete surveys * Provide blood, stool, and saliva samples * Maintain food logs

Lifestyle Intervention Among Participants of the French Colorectal Cancer Screening Program (LIFE-SCREEN)

The investigators propose a randomized controlled trial to develop and evaluate the impact of promoting advice on diet and lifestyle recommendations for cancer prevention at colorectal cancer screening among individuals who may be at higher risk for colorectal cancer (CRC). The specific objectives of this study are to 1) develop a lifestyle intervention based on evidenced-based diet and lifestyle recommendations (i.e. those proposed by the World Cancer Research Fund (WCRF) and the French National Cancer Institute); 2) evaluate the effect of the intervention on the adherence to the target diet and lifestyle recommendations as well as other subjective health measures, including quality of life; 3) evaluate the effect of the intervention on anthropometrics.