A Study of the Detection of Advanced Colorectal Neoplasia by Stool DNA Assessment in Inflammatory Bowel Disease

Overview

About this study

The purpose of this study is to determine the performance of the Exact IBD-ACRN (inflammatory bowel disease-advanced colorectal neoplasia)surveillance test to detect colorectal cancer (CRC) and colorectal neoplasia in patients with inflammatory bowel disease. Enrolled subjects must have undergone colonoscopy no more than 90 days prior to enrollment, will collect a stool sample for the surveillance test and then must undergo colonoscopy or surgical intervention within 120 days after enrollment.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Male or female
18-84 years of age, inclusive
Diagnosis of IBD or a diagnosis of PSC with IBD prior to enrollment date of this study
Must be a candidate for a surveillance colonoscopy, with the intention of CRC/dysplasia surveillance, or a candidate for surgical intervention based on prior histological confirmation of HGD or CRC
Written informed consent document signed and dated by the subject or legally acceptable representative

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 and without a concurrent PSC diagnosis
Participation in any clinical study within the previous 30 days wherein an investigational compound or device was, or may be, introduced into the subject

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator John Kisiel, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

John Kisiel, M.D.

Closed for enrollment

More information

Publications

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