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

NCT05929365 | Recruiting DMC

• 1 other identifier: NU22-08-00424
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Predictive Cancer Model

Keywords

phenotype; surveillance; colonoscopy; colorectal neoplasia; genetic mutation; metachronous lesions

Outcome Measures

Primary Outcomes (1)

• 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

  To identify patients with high risk of metachronous colorectal lesions and try to design and optimal intervals of surveillance colonoscopies, especially in the high-risk group of patients, using mutation and clinical-pathologic phenotype.

  5 years

Secondary Outcomes (2)

• Determination of the mutation profile colorectal lesions

  5 years

• Mutational profil of colorectal lesions

  5 years

Other Outcomes (3)

• Mutational phenotype of patient.

  5 years

• Metachronous lesions

  5 years

• Similarity of the mutation profile of lesions found in the same area

  5 years

Interventions

colonoscopy PROCEDURE

determine the mutation profile of resected colorectal neoplasia

Also known as: endoscopic resection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with colorectal neoplasia detected in diagnostic colonoscopy.

You may qualify if:

• Colorectal polyp larger than 10mm removed by colonoscopy therapeutic method (EPE, EMR, ESD)
• Signed informed consent with the study and with colonoscopy

You may not qualify if:

• FAP, HNPCC and other hereditary CRC syndromes probands
• Colonoscopy contraindication
• Severe acute inflammatory bowel disease
• Severe comorbidities; likely non-compliance of the patient

Sponsors & Collaborators

• Military University Hospital, Prague: lead

Study Sites (1)

Military University Hospital

Prague, 16902, Czechia

RECRUITING

Related Publications (1)

• 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.

  PMID: 39789214 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

colorectal lesions (polyps)

MeSH Terms

Interventions

Colonoscopy; Endoscopic Mucosal Resection

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Stepan Suchanek, assoc. prof.

  Military University Hospital, Prague

  PRINCIPAL INVESTIGATOR

• Ondrej Ngo, Mgr.

  Institute of Biostatistics and Analyses Brno

  STUDY DIRECTOR

• Lucie Benesova, RNDr.

  Genomac Research Institute Prague

  STUDY DIRECTOR

• Ondrej Majek, RNDr.

  Institute of Biostatistics and Analyses Brno

  STUDY CHAIR

• Tereza Halkova, Mgr.

  Genomac Research Institute Prague

  STUDY CHAIR

Central Study Contacts

Stepan Suchanek, assoc. prof.

CONTACT

973208367; stepan.suchanek@uvn.cz

Tomas Grega, MD, Ph.D.

CONTACT

973203076; tomas.grega@uvn.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2023
• First Posted: July 3, 2023
• Study Start: May 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

CZ (1)