GI Complications in Cancer Immunotherapy Patients
- Conditions
- Malignant Melanoma
- Registration Number
- NCT02784366
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
The purpose of this study is to establish a prospective observational cohort of cancer immunotherapy patients with GI side effects in order to identify biomarkers that predict GI complications due to treatment.
- Detailed Description
Primary objective
* To create a data and bio-specimen repository to enhance both safety and efficacy of immunotherapy
Secondary objective
* Identify biomarkers that may predict GI toxicity in cancer patients undergoing immunotherapy
* Define the clinical course of intestinal inflammation and identify genetic factors of therapeutic response to GI medications
* Analyze genotype-phenotype correlations in GI side effects in patients undergoing cancer immunotherapy
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Confirmed diagnosis of cancer
- Currently undergoing or have undergone immunotherapy
- History of a total colectomy
- History of inflammatory bowel disease (either ulcerative colitis or Crohn's disease)
- History of colitis on chemotherapy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Biospecimen collection 12 weeks To collect stool, blood, and colon biopsies and have the ability to identify predictive biomarkers in patients that develop colitis as a result of cancer immunotherapy.
GI disease activity 12 weeks To evaluate GI disease activity associated with cancer immunotherapy through a series of standardized questionnaires that measure severity of GI symptoms.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States