Recruiting

Observational StudyGI Complications in Cancer Immunotherapy Patients

Sponsor:

Massachusetts General Hospital

Code:

NCT02784366

Conditions

Malignant Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Malignant Melanoma

Study ID

NCT02784366

Start date

Aug, 2015

Status verified date

Apr, 2022

Completion date

Mar, 2024

Anticipated

Primary completion date

Mar, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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 measure

GI disease activity [ Time Frame: 12 weeks ]
Biospecimen collection [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Elizabeth Andrews, BS

617-724-2090 eaandrews@mgh.harvard.edu

Keri Sullivan, BS

617-724-5955 ksullivan79@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Elizabeth Andrews, BS

617-724-2090 eaandrews@mgh.harvard.edu

Keri Sullivan, BS

617-724-5955 ksullivan79@mgh.harvard.edu

Principal Investigator:

Michael Dougan, MD, PhD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Apr 5, 2022

Last verified

Apr, 2022

Keywords

Cancer immunotherapy
Ipilimumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2022-04-05.