Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events
Overview
- Phase
- Not Applicable
- Intervention
- Biospecimen Collection
- Conditions
- Malignancy
- Sponsor
- Alliance for Clinical Trials in Oncology
- Enrollment
- 240
- Locations
- 1244
- Primary Endpoint
- Establishment of a national biorepository including biospecimen and clinical data collections for future use
- Status
- Recruiting
- Last Updated
- last month
Overview
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.
Detailed 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 records are also reviewed for up to 1 year.
Investigators
Eligibility Criteria
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 hyperprogression for purposes of eligibility, institutions may contact the study chair and submit images for central review
- •Has not previously been registered to this study
Exclusion Criteria
- Not provided
Arms & Interventions
Observational (biospecimen collection, medical record review)
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.
Intervention: Biospecimen Collection
Observational (biospecimen collection, medical record review)
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.
Intervention: Medical Chart Review
Outcomes
Primary Outcomes
Establishment of a national biorepository including biospecimen and clinical data collections for future use
Time Frame: Up to 1 year
The objective of this study to establish a biorepository of biospecimen and clinical data. There is no primary clinical outcome for this study.