Last updated on June 2020

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


Brief description of study

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.

Detailed Study 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 3-5) 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.

Clinical Study Identifier: NCT04242095

Find a site near you

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Alegent Health Mercy Hospital

Council Bluffs, IA United States
2.17miles
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Creighton University Medical Center

Omaha, NE United States
5.16miles
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Recruitment Status: Open


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