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.
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
100
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGGI disease activity
To evaluate GI disease activity associated with cancer immunotherapy through a series of standardized questionnaires that measure severity of GI symptoms.
Time frame: 12 weeks
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.
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.