Markers of Inflammatory Bowel Disease Severity
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: 15-005747
Sponsor Protocol Number: 15-005747
About this study
The purpose of this study is to identify blood cell-specific DNA methylation and micro RNA markers in tissue and stool samples in patients wiht inflammatory bowel disease.
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 (apply to Aim 3, subject population #4 only):
- Moderate to severely active ulcerative colitis (defined by Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score of ≥2)
- Able to provide informed consent;
- Scheduled for disease severity assessment by endoscopy (colonoscopy or flexible sigmoidoscopy)
- Intended to return to our center for follow-up colonoscopic assessment of response to therapy
- Adjunctive medication may be administered; these include, corticosteroids, thiopurine immunomodulators, methotrexate, 5-aminosalicylate therapies
- Baseline endoscopy is negative for colorectal cancer or dysplasia
Exclusion Criteria:
- Patient has known primary aerodigestive cancer outside of the colon within the last 5 years
- Prior colonic resection
- Prior colonic neoplasia
- Diagnosis of FAP
- Diagnosis of Lynch
- Participation in another clinical trial of novel IBD therapeutic agent
- Use of off-label therapy
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