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van CCT (UK)

van CCT (UK)

Flat colonic neoplasms: a population-based study

- candidate number19656
- NTR NumberNTR4844
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-okt-2014
- Secondary IDsMEC 14-4-046 METC - Maastricht University Medical Center
- Public TitleFlat colonic neoplasms: a population-based study
- Scientific TitleFlat colonic neoplasms: a population-based study; Clinical features, epidemiology and genotype-phenotype associations
- hypothesis1. Flat adenomas are common findings in patients at average- or at high-risk for CRC;
2. Flat adenomas are characterized by a different molecular profile as compared to polypoid lesions; these molecular features are associated with an increased risk for progression to CRC;
3. Laterally spreading tumors have a distinct molecular profile compared to large sessile neoplasms;
4. Laterally spreading tumors of the non-granular subtype exhibit a more distinct molecular profile than their granular counterparts;
5. Serrated LSTs will have a distinct molecular profile from adenomatous LSTs.
- Healt Condition(s) or Problem(s) studiedColorectal cancer, Polyps, Adenomas
- Inclusion criteriaPatients referred for routine colonoscopy with or without positive familiy history for colorectal cancer.
- Exclusion criteriaPatients with a history of inflammatory bowel disease, polyposis syndrome and proved mutations (APC, MUTYH, MMR) are excluded from analysis.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupFactorial
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-feb-2008
- planned closingdate1-feb-2018
- Target number of participants25000
- Interventions1. Clinical data registration;
2. Molecular analysis of polypoid vs. flat colorectal lesions.
- Primary outcome1. Prevalence of flat colorectal lesions in a Dutch population, especially the prevalence of Laterally Spreading Tumors;
2. Clinical characteristics (e.g. location of lesions, percentage of high-grade dysplasia or early cancer);
3. Molecular charcteristics (epigenetic: methylation status and genetic) of flat vs. polypoid colorectal lesions;
4. Prevalence of flat advanced colorectal cancers vs. polypoid advanced colorecal cancers: clinical features of these lesions (e.g. tumor stage);
5. Relation between serrated and adenomatous polyps.
- Secondary outcomePrevalence and genotype and fenotype associations of flat colorectal lesions in patients at high-risk for colorectal cancer.
- TimepointsAnalysis will be performed after each colonoscopy.
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Maastricht University Medical Center (MUMC+), Department of Gastroenterology and Hepatology
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University Medical Center (MUMC+), Department of Gastroenterology and Hepatology
- Publications- Rondagh EJ, Masclee AA, Bouwens MW et al. Endoscopic red flags for the detection of high-risk serrated polyps: an observational study. Endoscopy 2011; 43: 1052-1058
- Rondagh EJ, Sanduleanu S, le Clercq CM et al. Diverticulosis and colorectal polyps at younger age: a possible link? Eur J Gastroenterol Hepatol 2011; 23: 1050-1055
- Rondagh EJ, Bouwens MW, Riedl RG et al. Endoscopic appearance of proximal colorectal neoplasms and potential implications for colonoscopy in cancer prevention. Gastrointest Endosc 2012; 75: 1218-1225
- Rondagh EJ, Masclee AA, van der Valk ME et al. Nonpolypoid colorectal neoplasms: gender differences in prevalence and malignant potential. Scand J Gastroenterol 2012; 47: 80-88
- Bouwens MW, Riedl RG, Bosman FT et al. Large proximal serrated polyps: natural history and colorectal cancer risk in a retrospective series. J Clin Gastroenterol 2013; 47: 734-735
- Bouwens MW, Winkens B, Rondagh EJ et al. Simple clinical risk score identifies patients with serrated polyps in routine practice. Cancer Prev Res (Phila) 2013; 6: 855-863
- Brief summaryThe cross-sectional study, initiated in 2008 at the Department of Gastroenterology of the MUMC+, will be prolonged. The focus will be the histopathological and molecular profile of flat adenomas, serrated adenomas and laterally spreading tumors. A cross-sectional cohort of all colonic neoplasms found during routine colonoscopies in an average population, guarantees maximum efficiency in using the present available data and diminishes the need for new patient cohorts in the future.
- Main changes (audit trail)
- RECORD9-okt-2014 - 19-jul-2015

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