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Trial Title:
Innovative Approach to Detect Recurrent Colorectal Lesions With Surveillance Via Mutation Analysis & Clinical Phenotype
NCT ID:
NCT05929365
Condition:
Predictive Cancer Model
Conditions: Keywords:
phenotype
surveillance
colonoscopy
colorectal neoplasia
genetic mutation
metachronous lesions
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
colonoscopy
Description:
determine the mutation profile of resected colorectal neoplasia
Other name:
endoscopic resection
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.
Criteria for eligibility:
Study pop:
Patients with colorectal neoplasia detected in diagnostic colonoscopy.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Military University Hospital
Address:
City:
Prague
Zip:
16902
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Stepan Suchanek, MD., Ph.D.
Phone:
973208367
Phone ext:
00420
Email:
stepan.suchanek@uvn.cz
Start date:
May 1, 2022
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Military University Hospital, Prague
Agency class:
Other
Source:
Military University Hospital, Prague
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05929365
