NCT05929365Recruiting
Innovative Approach to Detect Recurrent Colorectal Lesions With Surveillance Via Mutation Analysis & 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
Source: ClinicalTrials.gov · Last updated 3 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 25 Jun 2023
- Start date
- 1 May 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Military University Hospital, Prague
- NCT number
- NCT05929365
What you commit to
- Study type: Observational
- Planned participants: 200
- From 1 May 2022 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- FAP, HNPCC and other hereditary CRC syndromes probands
- Severe acute inflammatory bowel disease
Other
- Colonoscopy contraindication
- Severe comorbidities; likely non-compliance of the patient
Who the study is looking for
- Colorectal polyp larger than 10mm removed by colonoscopy therapeutic method (EPE, EMR, ESD)
- Signed informed consent with the study and with colonoscopy
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Military University Hospital Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.