Multi Parametric Test Predicting the Risk of Colorectal Neoplasia Recurrence
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|ClinicalTrials.gov Identifier: NCT03434925|
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : February 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer||Genetic: Multi-targeted next generation sequencing||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- 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
- 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.
- Risk of polyp recurrence [ Time Frame: 3 years ]Measurement of the number of local recurrences after resection of advanced colorectal neoplasia
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434925
|Contact: Stepan Suchanek, MD., Ph.D.||973208367 ext firstname.lastname@example.org|
|Contact: Michal Voska, MD.||973203050 ext email@example.com|
|Military University Hospital||Recruiting|
|Prague, Czechia, 16902|
|Contact: Stepan Suchanek, MD., Ph.D.|
|Study Director:||Stepan Suchanek, MD., Ph.D.||Military University Hospital|