Markers of Inflammatory Bowel Disease Severity

Overview

  • Study type

    Observational
  • Study IDs

  • Describes 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.
  • 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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

John Kisiel, M.D.

Open for enrollment

Contact information:

Kari Lowrie

(507)266-3778

Lowrie.Kari@mayo.edu

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CLS-20306509

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