GI Complications in Cancer Immunotherapy Patients
Purpose
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.
Condition
- Malignant Melanoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Confirmed diagnosis of cancer - Currently undergoing or have undergone immunotherapy
Exclusion Criteria
- History of a total colectomy - History of inflammatory bowel disease (either ulcerative colitis or Crohn's disease) - History of colitis on chemotherapy
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Cancer immunotherapy patients - no GI side effect | Cancer immunotherapy patients who do not develop GI side effects. | |
| Cancer immunotherapy patients - develop GI side effects | Cancer immunotherapy patients who develop GI side effects |
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Unknown status
- Sponsor
- Massachusetts General Hospital
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