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Evaluating Informatics-assisted Immune-related Adverse Event Detection to Improve Registration Onto a Biorepository
A Non-Interventional Pragmatic Clinical Trial of NLP Models for the Detection of Immune-Related Adverse Events
Who can join
All ages · All sexes
Full eligibility criteria
Inclusion Criteria: * Received or receiving a regimen containing one or more immuno-oncology therapeutics
About the study
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.
What is being tested
- Informatics system for eligibility monitoring (other)
- Standard eligibility monitoring (other)
Sponsor: Brigham and Women's Hospital · Participants: 100 · Started: Jun 17, 2025
Contact the study team
- Danielle Bitterman, MD · Phone: 617-632-5734
Official record on ClinicalTrials.gov — NCT06789601
Locations in the U.S.
| Massachusetts | Brigham and Women's Hospital, Boston Dana-Farber Cancer Institute, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.