GI Complications in Cancer Immunotherapy Patients

Mass General Brigham

Status: Unknown

Conditions: Malignant Melanoma

Study type: Observational

Funder types: Other

Identifiers

NCT02784366

15302

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Cancer immunotherapy patients - no GI side effect

Description:

Cancer immunotherapy patients who do not develop GI side effects.

Cancer immunotherapy patients - develop GI side effects

Description:

Cancer immunotherapy patients who develop GI side effects