Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2015-08-31
2024-03-31
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cancer immunotherapy patients - no GI side effect
Cancer immunotherapy patients who do not develop GI side effects.
No interventions assigned to this group
Cancer immunotherapy patients - develop GI side effects
Cancer immunotherapy patients who develop GI side effects
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Currently undergoing or have undergone immunotherapy
Exclusion Criteria
* History of inflammatory bowel disease (either ulcerative colitis or Crohn's disease)
* History of colitis on chemotherapy
18 Years
ALL
No
Sponsors
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Dana-Farber Cancer Institute
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Michael Dougan
Attending physician
Principal Investigators
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Michael Dougan, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Ryan J Sullivan, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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15302
Identifier Type: -
Identifier Source: org_study_id
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