Innovative Approach to Detect Recurrent Colorectal Lesions With Surveillance Via Mutation Analysis & Clinical Phenotype

NCT ID: NCT05929365

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2026-12-31

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.

Detailed Description

The aim of this prospective study is to identify patients with recurrent colorectal lesions risk and try to design an optimal intervals of surveillance colonoscopies, especially in the high-risk group of patients, using mutation and clinical-pathologic phenotype. The partial goals are: 1. Determination of the mutation profile and mutation burden in 200 patients based on examination of all their index and synchronous lesions found during index colonoscopy using an established PCR/DCE-based heteroduplex method. 2. Clinical and histopathological evaluation and mutational profiling of all metachronous lesions found during five-year surveillance period. 3. Correlation of clinical and histopathological parameters with mutational phenotype of patient. 4. Correlation of patient's mutational phenotype with an occurrence of metachronous lesion/s during surveillance period. 5. Comparison of the mutation profile of lesions from the index period withthe mutation profile of metachronous lesions. 6. Analysis of the similarity of the mutation profile of lesions found in the same / close areas of the colorectum.

Conditions

Predictive Cancer Model

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

colonoscopy

determine the mutation profile of resected colorectal neoplasia

Intervention Type: PROCEDURE

Other Intervention Names

endoscopic resection

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Military University Hospital, Prague

OTHER

Sponsor Role: lead

Responsible Party

Stepan Suchanek, MD., Ph.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stepan Suchanek, assoc. prof.

Role: PRINCIPAL_INVESTIGATOR

Military University Hospital, Prague

Ondrej Ngo, Mgr.

Role: STUDY_DIRECTOR

Institute of Biostatistics and Analyses Brno

Lucie Benesova, RNDr.

Role: STUDY_DIRECTOR

Genomac Research Institute Prague

Ondrej Majek, RNDr.

Role: STUDY_CHAIR

Institute of Biostatistics and Analyses Brno

Tereza Halkova, Mgr.

Role: STUDY_CHAIR

Genomac Research Institute Prague

Locations

Military University Hospital

Prague, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Stepan Suchanek, assoc. prof.

Role: CONTACT

stepan.suchanek@uvn.cz

973208367 ext. 00420

Tomas Grega, MD, Ph.D.

Role: CONTACT

tomas.grega@uvn.cz

973203076 ext. 00420

Facility Contacts

Stepan Suchanek, MD., Ph.D.

Role: primary

stepan.suchanek@uvn.cz

973208367 ext. 00420

References

Grega T, Kmochova K, Hejcmanova K, Ngo O, Brodyuk N, Majek O, Bures J, Urbanek P, Zavoral M, Suchanek S. Impact of narrow band imaging in prediction of histology of advanced colorectal neoplasia. Sci Rep. 2025 Jan 9;15(1):1414. doi: 10.1038/s41598-025-85669-w.

Reference Type: DERIVED

PMID: 39789214 (View on PubMed)

Other Identifiers

NU22-08-00424

Identifier Type: -

Identifier Source: org_study_id