An interventional study of Multi-targeted next generation sequencing in Colon Cancer, sponsored by Military University Hospital, Prague. Status unknown at 1 site in Czechia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-02-15.
Sponsored by Military University Hospital, Prague · Not applicable, Interventional, and Diagnostic
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.
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
This study's planned enrollment of 200 is above the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Military University Hospital, Prague is the lead sponsor of 13 studies on the registry; 4 are open to participants now.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Measurement of gene mutations associated with local recurrence of advanced colorectal neoplasia after endoscopic resection.
Time frame: 3 years
Risk of polyp recurrence
Measurement of the number of local recurrences after resection of advanced colorectal neoplasia
Time frame: 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.
Time frame: 3 years
Plan to share: Undecided
No publications or documents are linked to this record.
Started Apr 2017 (actual). Primary completion is estimated for Jan 2020, 33 months after the start.
Of 382 non-industry interventional studies with no phase under Colonic Neoplasms, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 55. This study's planned 33 months is close to that.
Counting every sponsor, half of 404 studies reached it within 30 months; a quarter within 16 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Military University Hospital, Prague