Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events
Alliance for Clinical Trials in Oncology
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.
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…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Received a regimen containing one or more immuno-oncology therapeutics * Must have experienced one or more of the following: * One or more serious (Grade 3-4) AEs that are likely immune-related * One or more Grade 2 dermatologic or rheumatologic AEs that are likely immune-related * Diagnosis of a rare infection, e.g., fungal or mycobacterial, after starting IO treatment \*\* Note: Diagnosis of SARS-CoV-2 (COVID-19) is excluded * Hyperprogression. Image submission for patients experiencing hyperprogression is required. For assistance in determining hyperprog…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of tissue, blood, and stool samples
- OtherMedical Chart Review
Review of medical records
Locations (626)
- Anchorage Associates in Radiation MedicineAnchorage, Alaska
- Anchorage Radiation Therapy CenterAnchorage, Alaska
- Alaska Breast Care and Surgery LLCAnchorage, Alaska
- Alaska Oncology and Hematology LLCAnchorage, Alaska
- Alaska Women's Cancer CareAnchorage, Alaska
- Anchorage Oncology CentreAnchorage, Alaska