GI Complications in Cancer Immunotherapy Patients

April 4, 2022 updated by: Michael Dougan, Massachusetts General Hospital
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Dougan, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with a diagnosis of cancer who have undergone or will be undergoing immunotherapy will be eligible for recruitment.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Dana-Farber Cancer Institute

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

May 6, 2016

First Submitted That Met QC Criteria

May 24, 2016

First Posted (Estimate)

May 27, 2016

Study Record Updates

Last Update Posted (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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