NCT05929365 Innovative Approach to Detect Recurrent Colorectal Lesions With Surveillance Via Mutation Analysis & Clinical Phenotype
| NCT ID | NCT05929365 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Military University Hospital, Prague |
| Condition | Predictive Cancer Model |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-05-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2022-05-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
It is known that the development of colorectal adenoma is dependent on the appearance of somatic mutations in protooncogenes and tumor suppressor genes. Based on our previous mutation analyses of 120 patients with high-risk adenoma removed by enbloc resection with subsequent colonoscopy after 1 year, there is a correlation between mutation in exon 7 of the TP53 gene and risk of early metachronous lesions development. The results also indicate that mutation phenotype (mutation profile and burden) of all lesions detected on index colonoscopy can determine risk of metachronous lesions. As not all synchronous lesions were analyzed and the surveillance colonoscopy interval was less than 3 years, this assumption could not be confirmed. In this study it is planned to perform mutation analysis of all synchronous lesions in 200 patients and correlate the data with appearance of metachronous lesions after 1, 3 and 5 years. Moreover, the mutation profile of all metachronous lesions developed during the 5 years of surveillance will be determinated and compared with mutation profile of index lesions from the same localization to verify their common biological origin. This all could help personalize the surveillance program in terms of reduction of the burden on the patient and endoscopic workplaces and risk of developing colorectal cancer in a particular patient.
Eligibility 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
Contact & Investigator
Stepan Suchanek, assoc. prof.
PRINCIPAL INVESTIGATOR
Military University Hospital, Prague
Frequently Asked Questions
Who can join the NCT05929365 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Predictive Cancer Model. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05929365 currently recruiting?
Yes, NCT05929365 is actively recruiting participants. Contact the research team at stepan.suchanek@uvn.cz for enrollment information.
Where is the NCT05929365 trial being conducted?
This trial is being conducted at Prague, Czechia.
Who is sponsoring the NCT05929365 clinical trial?
NCT05929365 is sponsored by Military University Hospital, Prague. The principal investigator is Stepan Suchanek, assoc. prof. at Military University Hospital, Prague. The trial plans to enroll 200 participants.
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