ESTABLISHMENT OF A NATIONAL BIOREPOSITORY TO ADVANCE STUDIES OF IMMUNE-RELATED ADVERSE EVENTS
Categories (click each to see list of all clinical trials associated with that category): Brain/Neuro (ONC), Breast (ONC), GI (ONC), GU (ONC), Thoracic (ONC)
Current Status: Open
Phase: N/A (Cancer Control)
Principal Investigator: Marr, Alissa
Eligibility: https://clinicaltrials.gov/study/NCT04242095?term=NCT04242095&rank=1
Summary
BRIEF 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.
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.