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Multi Parametric Test Predicting the Risk of Colorectal Neoplasia Recurrence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03434925
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Stepan Suchanek, MD., Ph.D., Military University Hospital, Prague

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.

Condition or disease Intervention/treatment Phase
Colon Cancer Genetic: Multi-targeted next generation sequencing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Development of a New Generation Multi Parametric Test for Prediction of Colorectal Neoplasia Recurrence
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : December 31, 2020

Intervention Details:
  • Genetic: Multi-targeted next generation sequencing
    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 Measures :
  1. Presence of genetic markers for local recurence after resection of colorectal neoplasia [ Time Frame: 3 years ]
    Measurement of gene mutations associated with local recurrence of advanced colorectal neoplasia after endoscopic resection.


Secondary Outcome Measures :
  1. Risk of polyp recurrence [ Time Frame: 3 years ]
    Measurement of the number of local recurrences after resection of advanced colorectal neoplasia

  2. Topographic heterogenity of polyps [ Time Frame: 3 years ]
    Measurement of topographical characteristics of colorectal neoplasia (such as demography, histology, tumour genetic heterogeneity and presence of frequently mutated genes) associated with local recurrence.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434925


Contacts
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Contact: Stepan Suchanek, MD., Ph.D. 973208367 ext 00420 stepan.suchanek@uvn.cz
Contact: Michal Voska, MD. 973203050 ext 00420 michal.voska@uvn.cz

Locations
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Czechia
Military University Hospital Recruiting
Prague, Czechia, 16902
Contact: Stepan Suchanek, MD., Ph.D.         
Sponsors and Collaborators
Military University Hospital, Prague
Investigators
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Study Director: Stepan Suchanek, MD., Ph.D. Military University Hospital
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Responsible Party: Stepan Suchanek, MD., Ph.D., MD., Ph.D., Military University Hospital, Prague
ClinicalTrials.gov Identifier: NCT03434925    
Other Study ID Numbers: 17-31909A
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stepan Suchanek, MD., Ph.D., Military University Hospital, Prague:
colorectal neoplasia
adenoma
colonoscopy
gene mutation
follow-up
recurrence
multiparametric test
Additional relevant MeSH terms:
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Recurrence
Neoplasms
Disease Attributes
Pathologic Processes