Innovative Approach to Detect Recurrent Colorectal Lesions With Surveillance Via Mutation Analysis & Clinical Phenotype - Trial NCT05929365

Timeline & Enrollment

Primary Outcome

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

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.

ICD-10 Classifications