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

ArmDescriptionAssigned 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

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Elizabeth Andrews, BS
617-724-2090
eaandrews@mgh.harvard.edu

More Details

Status
Unknown status
Sponsor
Massachusetts General Hospital

Study Contact

Elizabeth Andrews, BS
617-724-2090
eaandrews@mgh.harvard.edu

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