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

Conditions

• Immune Related Adverse Events
• Malignancy

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Informatics system for eligibility monitoring — OTHER
  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.
• Standard eligibility monitoring — OTHER
  Reporting of an eligible event to the biorepository study staff by the treating clinician and EHR review by the study staff.

Study Details

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 Dates

Start date

Jun 17, 2025

Status verified

Jun 2025

Primary completion

Aug 31, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Other: Standard monitoring
  Standard irAE monitoring for an eligible registration event.
• Experimental: Informatics-assisted monitoring
  Informatics-assisted monitoring plus standard monitoring

Primary Outcome Measure

Feasibility [ Time Frame: 2 months ]

Central Contacts

• Danielle Bitterman, MD
  617-632-5734
  [email protected]

Locations (2)

Find similar trials in Boston, MA

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