Detecting recurrent colorectal lesions using mutation analysis and clinical phenotype
Official title: 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
Run by Military University Hospital, Prague · NCT05929365 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Military University Hospital, Prague Academic / other |
| Locations | 1 site (Prague) |
| Status | Recruiting |
| Started | May 1, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 3, 2023 |
| Trial ID | NCT05929365 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients who have had colorectal polyps larger than 10mm removed and are willing to participate in the study.
✕Probably not a fit
Patients with hereditary colorectal cancer syndromes or severe comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While similar approaches have been explored, this study's specific focus on mutation analysis for surveillance intervals is relatively novel.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.