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

NCT06789601 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-06-19

No results posted yet for this study

Summary

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.

Conditions

  • Malignancy
  • Immune Related Adverse Events

Interventions

OTHER

Informatics system for eligibility monitoring

A daily automated data query of eligible subjects will collect EHR data, and our informatics system will be run on these data behind our institution's secure firewall. The daily list of subjects identified by the informatics system as having a new irAE will be accessed by the Alliance irAE biorespository study team at Dana-Farber/Brigham Cancer Center for review.

OTHER

Standard eligibility monitoring

Reporting of an eligible event to the biorepository study staff by the treating clinician and EHR review by the study staff.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Brigham and Women's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-17
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06789601 on ClinicalTrials.gov