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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02503696

Enrollment

697

Registered

2015-07-21

Start date

2014-09-30

Completion date

2016-06-30

Last updated

2016-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Diseases, Colorectal Cancer, Colorectal Neoplasms, Digestive System Diseases, Inflammatory Bowel Disease

Keywords

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

Brief summary

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).

Interventions

DEVICEStool Collection Kit

Stool Collection Kit.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 84 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity and Specificity of the Exact CRC diagnostic screening test.	15 months	The primary endpoint is point estimates of the sensitivity of the diagnostic test for detection of colorectal cancer in IBD patients.

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026