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Flat colorectal cancer precursor lesions: epidemiological aspects and molecular analysis.


- candidate number6043
- NTR NumberNTR1891
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-jun-2009
- Secondary IDsMEC 08-4-074 Metc - Maastricht University Medical Center
- Public TitleFlat colorectal cancer precursor lesions: epidemiological aspects and molecular analysis.
- Scientific TitleFlat colorectal precusor lesions in a Dutch population: epidemiological aspects, genotype-phenotype associations and molecular analysis.
- ACRONYMN/A
- 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. Serrated polyps are common findings in a population attending for routine colonoscopy.
- Healt Condition(s) or Problem(s) studiedColorectal cancer, Polyps, Adenomas, Family history, Flat, Non polypoid
- Inclusion criteriaPatients referred for routine colonoscopy with or without positive familiy history for colorectal cancer.
- Exclusion criteriaMolecular analysis: patients with inflammatory bowel disease.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-feb-2008
- planned closingdate1-aug-2009
- Target number of participants2500
- Interventions1. Clinical data registration;
2. Molecular analysis of polypoid vs. flat colorectal lesions.
- Primary outcome1. Prevalence of flat colorectal lesions in a Dutch population;
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 the colonoscopy.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESdrs. E. Rondagh
- CONTACT for SCIENTIFIC QUERIESdrs. E. Rondagh
- 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
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD30-jun-2009 - 6-okt-2009


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl