Evaluating Informatics-assisted Immune-related Adverse Event Detection to Improve Registration Onto a Biorepository

Recruiting now · Phase 1/Phase 2

Conditions studied: Malignancy, Immune Related Adverse Events

In brief

Immunotherapies have improved cancer outcomes, but have a unique profile of immune-related adverse events (irAEs). Biorepositories have been established to collect data and samples to help improve our understanding of irAEs, however identifying patients who are eligible for these biorepositories in a timely fashion can be challenging. The goal of this study is to determine if an informatics system for automated irAE detection can improve registration to a prospective irAE biorepository (NCT04242095). The informatics system automatically "reads" participants' electronic health records (EHRs) and determines whether that patient may be experiencing an irAE. The main questions it aims to answer are: * Is it feasible to implement an informatics system for daily analysis of EHR data to detect irAEs? * Does the automated irAE detection system improve registration rates to an irAE biorepository at our institution following an eligible irAE? Researchers will compare standard irAE monitoring to informatics-assisted irAE monitoring to see if using the informatics system increases the registration rate and improves data entry efficiency and quality. Participants will: * Be randomly assigned to standard monitoring or informatics-assisted monitoring for irAE detection. * Have their EHR reviewed to collect demographic, medical, and cancer treatment history. * Be monitored for irAEs through daily automated analysis of their EHR data for up to 12 months or until registration in the biorepository.

Key facts

Study ID
NCT06789601
Run by
Brigham and Women's Hospital
People needed
100
Starts
2025-06-17
Expected to finish
2027-08-31
Last updated by the study team
2025-06-19

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Where it is running

Full record on ClinicalTrials.gov

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