Collection of Research Data and Samples from Patients Treated with Immunotherapy to Study Its Side Effects

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Solid Tumor	NCT ID:	NCT04242095
Trial Phases:		Protocol IDs:	A151804 (primary) A151804 NCI-2019-07113
Eligibility:	0 Years and older, Male and Female	Study Type:	Other
Study Sponsor:	Alliance for Clinical Trials in Oncology
NCI Full Details:	http://clinicaltrials.gov/show/NCT04242095

Summary

This study 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.

Objectives

PRIMARY OBJECTIVE:
I. 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).

OUTLINE:
Patients undergo collection of tissue and blood samples (and optional stool samples from patients experiencing colitis) at the time of registration (within 96 hours of confirmation of one or more severe irAEs) and at 1 month after registration. Patients' medical records are also reviewed for 1 year.

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