Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)
|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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503696
|Study Chair:||Graham Lidgard, PhD||Exact Sciences|