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OPTIcal diagnosis of T1 Colorectal carcinoma And depth of invasion in Large (≥20 mm) non- pedunculated colorectal lesions


- candidate number23610
- NTR NumberNTR5561
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jan-2016
- Secondary IDs15-435 
- Public TitleOPTIcal diagnosis of T1 Colorectal carcinoma And depth of invasion in Large (≥20 mm) non- pedunculated colorectal lesions
- Scientific TitleOPTIcal diagnosis of T1 Colorectal carcinoma And depth of invasion in Large (≥20 mm) non- pedunculated colorectal lesions
- ACRONYMOPTICAL
- hypothesisWe aim to test the accuracy of Western gastroenterologists in differentiating T1 CRCs from its precursor lesions and subsequently in estimating invasion depth
- Healt Condition(s) or Problem(s) studiedColorectal cancer, Optical diagnosis
- Inclusion criteriaIn order to be eligible to participate in this study, a subject must meet all of the following criteria:
•≥18 years old
•Scheduled to undergo colonoscopy
• large (>20 mm) non-pedunculated colorectal lesions suspected to be an adenoma (LGD / HGD) or T1 CRC found during colonoscopy
- Exclusion criteriaNo exclusion criteria
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2015
- planned closingdate1-jul-2016
- Target number of participants343
- InterventionsThis is a multi-center, prospective, single-blinded trial. All image evaluators participating in this study will be blinded for the final histopathological diagnosis when evaluating the endoscopic features.
- Primary outcomeAccuracy in predicting T1 CRC and depth of invasion.
- Secondary outcomeAccuracy of the individual optical features.
- TimepointsOptical diagnosis [1 day]
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Yara Backes
- CONTACT for SCIENTIFIC QUERIES Yara Backes
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD14-jan-2016 - 7-feb-2016


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