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NCT02784366 Clinical Trial

GI Complications in Cancer Immunotherapy Patients

Malignant Melanoma Clinical Trial

Official title:
GI Complications in Cancer Immunotherapy Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02784366
Other study ID # 15302
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 2015
Est. completion date March 2024

Study information
Verified date April 2022
Source Massachusetts General Hospital
Contact Elizabeth Andrews, BS
Phone 617-724-2090
Email eaandrews@mgh.harvard.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Recruiting
Enrollment 100
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Massachusetts General Hospital Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary GI disease activity To evaluate GI disease activity associated with cancer immunotherapy through a series of standardized questionnaires that measure severity of GI symptoms. 12 weeks
Primary Biospecimen collection 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. 12 weeks
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