A Study of the Detection of Advanced Colorectal Neoplasia by Stool DNA Assessment in Inflammatory Bowel Disease
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 13-001775
NCT ID: NCT01819766
Sponsor Protocol Number: 2013-01
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 |
|
More information
Publications
Publications are currently not available