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ID04242095

National Biorepository for Patients Experiencing Serious Side Effects from Immunotherapy Collecting Tissue, Blood, and Medical Data to Improve Future Treatment

Led by Alliance for Clinical Trials in Oncology · Updated on 2026-08-05

240

Participants Needed

625

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research aims to establish a national biorepository by collecting research data and samples from patients who experience side effects from immunotherapy treatments used in cancer care. It focuses on patients who have serious immune-related reactions, rare infections, or accelerated tumor growth after receiving immuno-oncology therapies. The goal is to help researchers better predict, prevent, and treat these side effects in the future. Participants will have tissue and blood samples collected within 72 hours after confirmation of a serious immune-related side effect and again one month later. For patients experiencing colitis, stool samples may also be collected. Alongside sample collection, medical records will be reviewed for up to one year. This study is observational and involves no experimental treatments. During the study, participants will provide biospecimens at two time points and allow access to their medical records for a year. Researchers will analyze these samples and clinical data to build a resource for future studies on immune-related adverse events. The main outcome is the establishment of this biorepository, which will be maintained for up to one year after enrollment.

CONDITIONS

Brief Title

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

Research Team

D

David Kozono, MD, PhD

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