Multi Parametric Test Predicting the Risk of Colorectal Neoplasia Recurrence

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.

Study Overview

• Status: Unknown
• Conditions: Colon Cancer
• Intervention / Treatment: Genetic: Multi-targeted next generation sequencing

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 16902
    • Recruiting
    • Military University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• Recent diagnostic, follow-up or preventive colonoscopy (FOBT-positive colonoscopy, screening colonoscopy) in ≤ 3 years
• Colonoscopy contraindication
• Severe acute inflammatory bowel disease
• Severe comorbidities; likely non-compliance of the patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of genetic markers for local recurence after resection of colorectal neoplasia	Measurement of gene mutations associated with local recurrence of advanced colorectal neoplasia after endoscopic resection.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of polyp recurrence	Measurement of the number of local recurrences after resection of advanced colorectal neoplasia	3 years
Topographic heterogenity of polyps	Measurement of topographical characteristics of colorectal neoplasia (such as demography, histology, tumour genetic heterogeneity and presence of frequently mutated genes) associated with local recurrence.	3 years

Collaborators and Investigators

• Sponsor: Military University Hospital, Prague
• Investigators: Study Director: Stepan Suchanek, MD., Ph.D., Military University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: February 14, 2018
• First Posted (Actual): February 15, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2018
• Last Update Submitted That Met QC Criteria: February 14, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: follow-up; colonoscopy; recurrence; adenoma; colorectal neoplasia; gene mutation; multiparametric test
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Neoplasms; Recurrence
• Other Study ID Numbers: 17-31909A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No