GI Complications in Cancer Immunotherapy Patients

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02784366

Enrollment

100

Registered

2016-05-27

Start date

2015-08-31

Completion date

2024-03-31

Last updated

2022-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Melanoma

Keywords

Cancer immunotherapy, Ipilimumab

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.

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

United States

Contacts

Primary ContactElizabeth Andrews, BS

eaandrews@mgh.harvard.edu617-724-2090

Backup ContactKeri Sullivan, BS

ksullivan79@mgh.harvard.edu617-724-5955

Outcome results