Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease: OCEANIA Study
This is a prospective, cross sectional, multi-center study to determine the sensitivity and
specificity of the Exact IBD-ACRN surveillance test for detecting CRC alone and in
combination with high grade dysplasia (HGD) and low grade dysplasia (LGD) associated with
IBD and advanced adenoma in IBD patients with disease duration greater than 8 years or PSC
diagnosis. Enrolled subjects will provide a single stool sample for the Exact IBD-ACRN
surveillance test, no sooner than 7 days following their most recent pre-enrollment
colonoscopy, within 30 days of enrollment and prior to initiating bowel prep for either the
post-enrollment colonoscopy (surveillance or repeat), or surgical intervention. Stool
samples will be tested using the Exact IBD-ACRN surveillance test and results compared to
the colonoscopy and corresponding diagnostic histopathology results from biopsied, and any
subsequently excised, lesions to establish sensitivity and specificity of the Exact IBD-ACRN
surveillance test. All post-enrollment colonoscopies or surgical interventions must be
performed within 60 days of enrollment.
The primary objective of this study is to determine the sensitivity and specificity of the
Exact IBD-ACRN surveillance test for CRC in IBD patients with disease duration of at least
eight years or diagnosis of PSC. Tissue diagnosis of CRC will be established by
histopathology examination. The secondary objective is to determine the sensitivity and
specificity of the Exact IBD-ACRN surveillance test to detect ACRN in IBD patients with
disease duration of at least eight years or diagnosis of PSC.
Enrollment will continue until at least 30 CRC; 20 HGD and 240 negative subject samples have
been obtained. There is no specific recruitment goal for IBD associated LGD or LGD
associated with advanced adenoma (AA).
Observational Model: Case Control, Time Perspective: Cross-Sectional
Sensitivity and Specificity of the Exact Sciences IBD-ACRN screening test for CRC.
With comparison to the colonoscopy results and histopathologic diagnosis of all lesions discovered during colonoscopy and either biopsied or removed during or subsequently removed after colonoscopy.
Steven Itzkowitz, MD
Icahn School of Medicine at Mount Sinai
United States: Institutional Review Board
Exact Sciences 2013-01
|Mount Sinai School of Medicine||New York, New York 10029|
|University of Wisconsin Hospital and Clinics||Madison, Wisconsin 53792-0001|
|Wisconsin Center for Advanced Research||Milwaukee, Wisconsin 53207|
|Advanced Research Institute||Logan, Utah 84341|
|Gastroenterology Associates, LLC||Baton Rouge, Louisiana 70809|
|MGG Group, Co. Inc./Chevy Chase Clinical Research||Chevy Chase, Maryland 20815|
|Center for Digestive and Liver Diseases, Inc||Mexico, Missouri 65265|
|Medical Research Associates of New York||New York, New York 10075|
|Asheville Gastroeneterology Associates||Asheville, North Carolina 28801|