Multi Parametric Test Predicting the Risk of Colorectal Neoplasia Recurrence
Primary Purpose
Colon Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Multi-targeted next generation sequencing
Sponsored by
About this trial
This is an interventional diagnostic trial for Colon Cancer focused on measuring colorectal neoplasia, adenoma, colonoscopy, gene mutation, follow-up, recurrence, multiparametric test
Eligibility 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
- 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
Sites / Locations
- Military University HospitalRecruiting
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Risk of polyp recurrence
Measurement of the number of local recurrences after resection of advanced colorectal neoplasia
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.
Full Information
NCT ID
NCT03434925
First Posted
January 31, 2018
Last Updated
February 14, 2018
Sponsor
Military University Hospital, Prague
1. Study Identification
Unique Protocol Identification Number
NCT03434925
Brief Title
Multi Parametric Test Predicting the Risk of Colorectal Neoplasia Recurrence
Official Title
Development of a New Generation Multi Parametric Test for Prediction of Colorectal Neoplasia Recurrence
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Military University Hospital, Prague
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
colorectal neoplasia, adenoma, colonoscopy, gene mutation, follow-up, recurrence, multiparametric test
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
Multi-targeted next generation sequencing
Intervention Description
Study directed at finding molecular predictors of recurrent colorectal adenomas also taking into account the intrinsic level of heterogenity imprinted in the internal differences in molecular profiles
Primary Outcome Measure Information:
Title
Presence of genetic markers for local recurence after resection of colorectal neoplasia
Description
Measurement of gene mutations associated with local recurrence of advanced colorectal neoplasia after endoscopic resection.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Risk of polyp recurrence
Description
Measurement of the number of local recurrences after resection of advanced colorectal neoplasia
Time Frame
3 years
Title
Topographic heterogenity of polyps
Description
Measurement of topographical characteristics of colorectal neoplasia (such as demography, histology, tumour genetic heterogeneity and presence of frequently mutated genes) associated with local recurrence.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stepan Suchanek, MD., Ph.D.
Phone
973208367
Ext
00420
Email
stepan.suchanek@uvn.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Michal Voska, MD.
Phone
973203050
Ext
00420
Email
michal.voska@uvn.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stepan Suchanek, MD., Ph.D.
Organizational Affiliation
Military University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Military University Hospital
City
Prague
ZIP/Postal Code
16902
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stepan Suchanek, MD., Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Multi Parametric Test Predicting the Risk of Colorectal Neoplasia Recurrence
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