GI Complications in Cancer Immunotherapy Patients



Status:Recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/15/2018
Start Date:August 2015
End Date:March 2020
Contact:Elizabeth Andrews, BS
Email:eaandrews@mgh.harvard.edu
Phone:617-724-2090

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Trial Summary
Trial Overview
Inclusion Criteria
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.

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

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
We found this trial at
1
site
Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Michael Dougan, MD, PhD
Phone: 617-724-2090
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mi
from
Boston, MA
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