Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease (OCEANIA)
This study aims to determine the performance of the Exact IBD-ACRN surveillance test to detect colorectal cancer (CRC) and colorectal neoplasia in patients with inflammatory bowel disease (IBD). Patients with an IBD diagnosis for at least eight years or diagnosis of primary sclerosing cholangitis (PSC) and who are eligible for CRC screening are eligible to participate in this study. Enrolled subjects will collect a stool sample for the Exact IBD-ACRN surveillance test. Subjects must have undergone colonoscopy no more than 90 days prior to enrollment and will undergo colonoscopy or surgical intervention within 120 days of enrollment. Tissue diagnosis of CRC will be established by histopathologic examination.
Inflammatory Bowel Disease (IBD)
Primary Sclerosing Cholangitis (PSC)
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Detection of Advanced Colorectal Neoplasia by Stool DNA in Inflammatory Bowel Disease: OCEANIA Study|
- Sensitivity and Specificity of the Exact Sciences IBD-ACRN screening test for CRC. [ Time Frame: 9 months ] [ Designated as safety issue: No ]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.
- Determine Sensitivity and Specificity of the Exact Sciences IBD-ACRN screening test for CRC and HGD. [ Time Frame: 9 months ] [ Designated as safety issue: No ]Subjects with colonoscopic findings of CRC and/or high grade dysplasia (HGD) will be considered to have a positive outcome for composite CRC-HGD sensitivity calculations. Subjects with negative colonoscopic findings will be considered to have a negative outcome.
Biospecimen Retention: Samples With DNA
Residual samples may be archived for further research. Clinical data and samples will be kept in a manner that preserves anonymity of the subject. Specimens will be stored in a commercial biorepository contracted by Exact Sciences or at Exact Sciences and may be used for future research.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
IBD or PSC
Subjects will be men and women, 18 to 84 years of age, inclusive, who are at increased risk of developing colorectal cancer.
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 35 CRC; 15 HGD and 315 negative subject samples have been obtained. There is no specific recruitment goal for IBD associated LGD or LGD associated with advanced adenoma (AA).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01819766
|Contact: Toby Vaughnfirstname.lastname@example.org|
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|Principal Investigator:||Steven Itzkowitz, MD||Mount Sinai School of Medicine|