Detecting recurrent colorectal lesions using mutation analysis and clinical phenotype
Development and Clinical Utility of a New Method to Identify Patients With Risk of Recurrent Colorectal Lesions and Personalization of Their Surveillance Based on Mutation Burden and Clinical-pathological Phenotype
This study is testing if looking at genetic changes in colorectal polyps can help doctors better predict and monitor the risk of new lesions in patients who have had high-risk adenomas removed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Military University Hospital, Prague Academic / other |
| Locations | 1 site (Prague) |
| Trial ID | NCT05929365 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify the risk of recurrent colorectal lesions in patients by analyzing somatic mutations in their colorectal polyps. It will involve mutation analysis of all synchronous lesions in 200 patients who have had high-risk adenomas removed, followed by surveillance colonoscopies at 1, 3, and 5 years to monitor for metachronous lesions. The study will correlate mutation profiles with clinical and histopathological parameters to optimize surveillance intervals for high-risk patients.
Who should consider this trial
Good fit: Ideal candidates are patients who have had colorectal polyps larger than 10mm removed and are willing to participate in the study.
Not a fit: Patients with hereditary colorectal cancer syndromes or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective surveillance strategies for patients at high risk of colorectal cancer.
How similar studies have performed: While similar approaches have been explored, this study's specific focus on mutation analysis for surveillance intervals is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Colorectal polyp larger than 10mm removed by colonoscopy therapeutic method (EPE, EMR, ESD) * Signed informed consent with the study and with colonoscopy Exclusion Criteria: * FAP, HNPCC and other hereditary CRC syndromes probands * Colonoscopy contraindication * Severe acute inflammatory bowel disease * Severe comorbidities; likely non-compliance of the patient
Where this trial is running
Prague
- Military University Hospital — Prague, Czechia (Recruiting)
Study contacts
- Principal investigator: Stepan Suchanek, assoc. prof. — Military University Hospital, Prague
- Study coordinator: Stepan Suchanek, assoc. prof.
- Email: stepan.suchanek@uvn.cz
- Phone: 973208367
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.