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Completed

NCT Number: NCT02503696

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

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).

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Key information

Conditions

Inflammatory Bowel Disease Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Inflammatory Bowel Diseases Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Calgary - Division of Gastroenterology, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stool Collection Kit

Device

Stool Collection Kit.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Exact Sciences Corporation

Industry

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jul 21, 2015
Registry last updated
Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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