Accuracy for Predicting Deep Submucosal Invasion
Completed
Conditions studied: Colorectal Cancer, Colorectal Polyp
In brief
The main aim of this study is to determine whether the assessment of the invasive pattern based on NBI with dual focus/magnification or BLI with magnification ± chromoendoscopy (NBI+CE) for predicting deep invasion is significantly more accurate than the assessment based on white light endoscopy (WLE), carried out by trained endoscopists.
Key facts
- Study ID
- NCT03748667
- Run by
- Althaia Xarxa Assistencial Universitària de Manresa
- People needed
- 426
- Starts
- 2018-12-01
- Expected to finish
- 2022-10-30
- Last updated by the study team
- 2023-09-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Non-pedunculated type 0 lesions in Paris classification (not obvious cancers)
- Lesions larger than 10 mm
- Exclusion criteria are:
- Lesions assessed as JNET 1 by the endoscopist or serrated by the pathologist
- Previous biopsy or resection attempt
- Previous CT, MR or USE
- Unavailable histology
- Inflammatory bowel disease
- Informed consent not obtained
- Protocol violation
Where it is running
- San Francisco Veterans Affairs Medical Center. University of California — San Francisco, California, United States
- University of North Carolina — Chapel Hill, North Carolina, United States
- National Cancer Center — Tokyo, Japan
- Hospital Clínico Universitario Lozano Blesa — Zaragoza, Aragon, Spain
- Hospital Universitari Germans Trias i Pujol (Can Ruti) — Badalona, Catalonia, Spain
- Hospital Clínic de Barcelona — Barcelona, Catalonia, Spain
- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) — Barcelona, Catalonia, Spain
- Althaia. Xarxa Assistencial Universitària de Manresa — Manresa, Catalonia, Spain
- Hospital Clinico Universitario Virgen de la Arrixaca — El Palmar, Murcia, Spain
- Hospital Comarcal de Alcañiz — Alcañiz, Teruel, Spain
- Hospital Universitario y Politécnico de La Fe — Valencia, Valencia, Spain
- Centro Médico Teknon — Barcelona, Spain
- Hospital Ramón y Cajal — Madrid, Spain
- Hospital 12 de Octubre — Madrid, Spain
Full record on ClinicalTrials.gov
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