Safety of Immunosuppression in A Prospective Cohort of Inflammatory Bowel Disease Patients With a History of Cancer (SAPPHIRE)

Clinical Trial Details

This is a prospective, multi-center, observational study designed to determine if specific agents used for treatment of inflammatory bowel disease (IBD) are associated with the development of new or recurrent cancer in patients with IBD and a history of cancer.

Commitments for enrollment include:

A baseline 15-minute questionnaire related to demographics and health at your clinic visit
A yearly 15-minute follow-up questionnaire (one every 12 months for a period of 5 years), either in person, over the phone, or email, to see if there were changes to your health and/or IBD/cancer conditions

Note: No invasive tests (blood tests, x-rays, endoscopies, or other procedures) will be performed for the purpose of this research study. No drugs or devices will be administered to you as part of this study.

Key Eligibility:

Age 18 or older at entry
Diagnosis of Crohn’s disease, ulcerative colitis, or indeterminate colitis
Have IBD and a diagnosis of a new or prior cancer diagnosis within the last 5 years

Exclusion Criteria

Current enrollment in a clinical trial of an investigational therapy for Crohn’s disease or ulcerative colitis
IBD patients with a cancer diagnosis > 5 years prior to study entry
IBD patients with active chemotherapy or radiation cancer treatment at enrollment

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