An observational study in Inflammatory Bowel Disease (IBD), Primary Sclerosing Cholangitis (PSC) and Colorectal Neoplasms, sponsored by Exact Sciences Corporation. Completed at 26 sites in 2 countries. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2017-02-17.
Sponsored by Exact Sciences Corporation · Observational
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.
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).
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 440 is above the median of 204 across 1,683 observational studies indexed under Neoplasms.
Browse Neoplasms studies →Exact Sciences Corporation is the lead sponsor of 31 studies on the registry; 2 are open to participants now.
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Subjects who have diagnosed IBD and are undergoing a colorectal cancer surveillance program. Also, have either a histopathological diagnosis of high grade dysplasia or colorectal cancer resulting from colonoscopy preceding enrollment or for whom a surveillance colonscopy is indicated.
Exclusion Criteria:
Subjects will be men and women, 18 to 84 years of age, inclusive, who are at increased risk of developing colorectal cancer.
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.
Time frame: 9 months
Determine Sensitivity and Specificity of the Exact Sciences IBD-ACRN screening test for CRC and HGD.
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.
Time frame: 9 months
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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