Sample Collection Study to Evaluate DNA Markers in Subjects With Inflammatory Bowel Disease (IBD)

Overview

The primary objective of this study is to gather stool samples from subjects with inflammatory bowel disease (IBD) to be added to a test set of stool samples that will be utilized to help select molecular markers and determine the optimal sensitivity and specificity values for the Exact IBD-ACRN surveillance test for colorectal cancer (CRC).

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2015

Interventions

  • Device: Stool Collection Kit
    • Stool Collection Kit.

Arms, Groups and Cohorts

  • IBD
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Male or Female 18 – 84 years of age, inclusive, who have been diagnosed with IBD. – Willing to provide a stool sample ≤120 but ≥7 days after a surveillance colonoscopy, which was negative for cancer/dysplasia. – Written informed consent document signed and dated by the subject. Exclusion Criteria:

  • Any condition that in the opinion of the investigator should preclude participation in the study. – A history of aerodigestive tract cancer. – Prior colorectal resection, except ileocolic resection in Crohn's disease patients. – IBD limited only to the rectum. – Subject has participated in any clinical study within the previous 30 days wherein an investigational compound or device was, or may have been, introduced into the subject.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 84 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Exact Sciences Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Graham Lidgard, PhD, Study Chair, Exact Sciences

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