Informatics-assisted detection of immune-related side effects to improve biorepository enrollment
Official title: A Non-Interventional Pragmatic Clinical Trial of NLP Models for the Detection of Immune-Related Adverse Events
Run by Brigham and Women's Hospital · NCT06789601 · Data updated 2026-11-12
This project tests whether an automated system that reads electronic health records can help identify cancer patients on immunotherapy who are having immune-related side effects so they can be enrolled in a biorepository.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Status | Recruiting |
| Started | June 17, 2025 |
| Main results expected | August 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | June 19, 2025 |
| Trial ID | NCT06789601 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are cancer patients receiving or who have received immuno-oncology therapies at the participating institutions and whose care is documented in the local EHR.
✕Probably not a fit
Patients not treated at the participating centers, not receiving immunotherapy, or without relevant EHR documentation of an irAE are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-institution, randomized controlled study at Dana-Farber/Brigham Cancer Center will compare standard monitoring versus an informatics system that daily analyzes EHR notes to flag possible immune-related adverse events (irAEs). About 100 patients receiving immunotherapy will be randomized to either usual eligibility monitoring or informatics-assisted monitoring. Co-primary endpoints are feasibility of daily EHR inferencing and whether the system increases registration rates onto a prospective irAE biorepository. Secondary endpoints include time from irAE to data entry and expert-reviewed irAE capture rate.
Why it matters
Potential benefit: If successful, this approach could increase and speed enrollment of immunotherapy patients with irAEs into a biorepository, improving sample availability for research that may lead to better understanding and management of these side effects.
How similar studies have gone: Natural language processing and EHR-based surveillance have shown promise for detecting adverse events in prior work, but applying automated detection specifically to improve biorepository registration is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Received or receiving a regimen containing one or more immuno-oncology therapeutics
Where it's running
-
Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting -
Dana-Farber Cancer Institute
Boston, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Danielle Bitterman, MD
- Email: dbitterman@bwh.harvard.edu
- Phone: 617-632-5734
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.