Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)
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|ClinicalTrials.gov Identifier: NCT02503696|
Recruitment Status : Completed
First Posted : July 21, 2015
Last Update Posted : August 10, 2016
|Condition or disease||Intervention/treatment|
|Inflammatory Bowel Disease Colorectal Neoplasms Digestive System Diseases Colonic Diseases Colorectal Cancer||Device: Stool Collection Kit|
|Study Type :||Observational|
|Actual Enrollment :||697 participants|
|Official Title:||Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||June 2016|
Subjects will be men and women, 18-84 years of age, inclusive, who have been diagnosed with IBD. Each with a screening colonoscopy resulting in normal findings.
Device: Stool Collection Kit
Stool Collection Kit.
- Sensitivity and Specificity of the Exact CRC diagnostic screening test. [ Time Frame: 15 months ]The primary endpoint is point estimates of the sensitivity of the diagnostic test for detection of colorectal cancer in IBD patients.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503696
|Study Chair:||Graham Lidgard, PhD||Exact Sciences|