Establishment of a National Biorepository to Advance Studies of Immune-Related Adverse Events
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- STATUS
- Recruiting
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- End date
- Feb 14, 2025
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- participants needed
- 240
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- sponsor
- 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 records are also reviewed for up to 1 year.
Details
| Condition | Malignancy |
|---|---|
| Treatment | medical chart review, biospecimen collection |
| Clinical Study Identifier | NCT04242095 |
| Sponsor | Alliance for Clinical Trials in Oncology |
| Last Modified on | 14 October 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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