Colon Cancer Clinical Trial
Official title:
Development of a New Generation Multi Parametric Test for Prediction of Colorectal Neoplasia Recurrence
This project is dedicated to identify the patients with possible higher risk of adenoma recurrence who should have follow-up colonoscopy in yearly interval. As a result, it can lead to optimizing the of follow-up colonoscopies intervals in real-world practice.
In this project, 200 individuals (aged 18 - 75 years) with removed colorectal polyps larger
than 10 mm during colonoscopy performed based on all indication (including symptoms and
screening procedures) will be included. All procedures will be done with high quality
endoscopes (high definition, HD).
In all polyps, the advanced imaging techniques (such as chromoendoscopy and NBI) will be used
to determine parts of the polyp suspicious from high-grade dysplasia or cancer. The
therapeutic method will be decided by the size and macroscopic appearance of the polyp. In
case of flat, sessile polyps and LST lesions (laterally spreading tumors) EMR or ESD will be
performed. Pedunculated polyp will be removed by EPE. The goal is to achieve the en-bloc
resection. Pathologists (with presence of the endoscopist) will do the first step of
histopathology evaluation (cutting the polyp tissue). The aim is to perform the first cut in
the most advanced part of the polyp and high density cutting in this area. Standard
histopathology evaluation will proceed and will be followed by initial basic molecular
testing.
Subsequently, all patients will be observed by colonoscopy in one-year intervals with focus
on polyp recurrence. The group of high-risk patients will be selected with at least one of
these criteria: 1/ high grade dysplasia adenoma at index colonoscopy; 2/ high score of polyp
heterogenity at index colonoscopy; 3/ polyps recurrence at follow-up colonoscopy.
In a high-risk patients group the extensive somatic mutations profiling will be carried out
according to multitarget sequencing by NGS technologies (next generation sequencing). Same
testing will be done in randomly selected patients not included in the high-risk group, which
will be used as a control group for statistical evaluation.
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