Evaluating Informatics-assisted Immune-related Adverse Event Detection

This study is looking at a new way to identify patients who experience immune-related adverse events (irAEs) (side effects from immunotherapy that happen when your immune system attacks healthy cells). Immunotherapies are treatments that help your own immune system fight cancer. The study wants to see if using a special computer system (informatics system) to automatically check your electronic health records (EHRs) can help find patients with new irAEs more quickly than standard methods. This would help more patients join a biorepository (a collection of samples and data) that studies irAEs. About 100 patients who are receiving or have received immunotherapy for cancer can join this study. The main goals are to see if the computer system is practical to use and if it helps more patients get registered into the biorepository.

Study design
This is a randomized controlled trial involving about 100 participants. It compares an informatics system for eligibility monitoring with standard eligibility monitoring.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures feasibility at 2 months and registration at 12 months.

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NCT06789601

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

Recruiting
PHASE1All AgesInterventional
Brigham and Women's Hospital
~100 participants
Updated 2025-06-19 on ClinicalTrials.gov
What's tested:Informatics system for eligibility monitoringStandard eligibility monitoring

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility
Measured over 2 months
+1 more outcome measured
Malignancy
Immune Related Adverse Events
2 sites across 1 states
Massachusetts2

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Eligibility criteria

Inclusion

Received or receiving a regimen containing one or more immuno-oncology therapeutics
  • Feasibility2 months

    Feasibility is defined as successfully connecting the informatics system to subjects' relevant EHR data, carrying out inferencing on the records, and reporting newly identified automatically extracted irAEs in a tabular format daily for a minimum of 1 week. Feasibility is defined at the patient-level.

  • Registration12 months

    Registration rate is the proportion of subjects who are registered onto a prospective irAE biopository at Dana Farber/Brigham Cancer Center. Patients are eligible for biorepository registration within 96 hours of a severe (grade 3-4) irAE.