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Collection of Research Data and Samples From Patients Who Experience Immunotherapy Side Effects

Malignancy Clinical Trial

Official title:
Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events

Clinical Trial Summary

This trial collects research data and samples from patients who experience immunotherapy side effects to store for use in future research studies. Studying research data and samples from patients who experience immunotherapy side effects may help researchers better understand how to predict, prevent, and treat these side effects.

Clinical Trial Description

PRIMARY OBJECTIVES: To establish a national biorepository including biospecimen and clinical data collections from patients treated with immuno-oncology (IO) therapeutics who experience one or more serious (grade 3-4) immune-related adverse events (irAEs), rare infections or hyperprogression (acceleration of tumor growth). OUTLINE: Patients undergo collection of tissue and blood samples (and optional stool samples from patients experiencing colitis) at the time of registration (within 72 hours of confirmation of one or more severe irAEs) and at 1 month after registration. Patients' medical records are also reviewed for up to 1 year. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04242095
Study type Observational
Source Alliance for Clinical Trials in Oncology
Contact David Kozono, MD, PhD
Phone 617-632-5734
Email dkozono@bwh.harvard.edu
Status Recruiting
Phase
Start date January 31, 2020
Completion date October 1, 2025
View Details
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