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GI Complications in Cancer Immunotherapy Patients

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT02784366
Collaborator
Dana-Farber Cancer Institute (Other)
100
Enrollment
1
Location
103
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    GI Complications in Cancer Immunotherapy Patients
    Study Start Date :
    Aug 1, 2015
    Anticipated Primary Completion Date :
    Mar 1, 2024
    Anticipated Study Completion Date :
    Mar 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital
    • Dana-Farber Cancer Institute

    Investigators

    • Principal Investigator: Michael Dougan, MD, PhD, Massachusetts General Hospital
    • Principal Investigator: Ryan J Sullivan, MD, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michael Dougan, Attending physician, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT02784366
    Other Study ID Numbers:
    • 15302
    First Posted:
    May 27, 2016
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Michael Dougan, Attending physician, Massachusetts General Hospital
    Cancer immunotherapy
    Ipilimumab
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of Apr 5, 2022