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GI Complications in Cancer Immunotherapy Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02784366
Recruitment Status : Recruiting
First Posted : May 27, 2016
Last Update Posted : August 13, 2018
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Michael Dougan, Massachusetts General Hospital

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
Malignant Melanoma

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

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: GI Complications in Cancer Immunotherapy Patients
Study Start Date : August 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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.

  2. 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.

Biospecimen Retention:   Samples With DNA
Blood and stool samples will be collected.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02784366

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Contact: Elizabeth Andrews, BS 617-724-2090
Contact: Keri Sullivan, BS 617-724-5955

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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Elizabeth Andrews, BS    617-724-2090   
Contact: Keri Sullivan, BS    617-724-5955   
Principal Investigator: Michael Dougan, MD, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
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Principal Investigator: Michael Dougan, MD, PhD Massachusetts General Hospital
Principal Investigator: Ryan J Sullivan, MD Massachusetts General Hospital

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Responsible Party: Michael Dougan, Attending physician, Massachusetts General Hospital Identifier: NCT02784366     History of Changes
Other Study ID Numbers: 15302
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Michael Dougan, Massachusetts General Hospital:
Cancer immunotherapy

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Immunologic Factors
Physiological Effects of Drugs