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

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.

Study Overview

• Status: Recruiting
• Conditions: Malignancy; Immune Related Adverse Events
• Intervention / Treatment: Other: Standard eligibility monitoring; Other: Informatics system for eligibility monitoring

Detailed Description

This is a single institution, randomized controlled trial of an informatics system for automated immune-related adverse event (irAE) detection from the electronic health records (EHR) for eligibility monitoring for an Alliance prospective irAE biorepository (NCT04242095). This study will enroll approximately 100 patients receiving immunotherapy. Our co-primary endpoints test the hypothesis that informatics-assisted EHR monitoring for biorepository eligibility is feasible and improves registration rates onto the biorepository following an eligible irAE. Secondary endpoints evaluate time to data entry after an irAE, and irAE capture rate based on post-hoc subject matter expert review. This study will take place at Dana-Farber/Brigham Cancer Center.

Our co-primary objectives are:

1. To establish the feasibility of implementing the informatics system for daily inferencing on EHR data
2. To assess the ability of automated irAE detection to improve registration to a prospective irAE biorepository

Our secondary objectives are:

1. To evaluate whether automated irAE detection reduces the time to data entry in a prospective biorepository data management system
2. To evaluate whether automated irAE detection leads to differences in irAE capture rates of patients with an eligible irAE based on clinician expert review of the EHR

Subjects will be randomized to standard irAE monitoring for an eligible registration event (control arm) vs. informatics-assisted irAE monitoring for an eligible registration event (experimental arm). There will be a seamless feasibility run-in of the first 10-20 patients to establish feasibility. These subjects will be included in the full analysis.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Danielle Bitterman, MD; Phone Number: 617-632-5734; Email: dbitterman@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Danielle Bitterman, MD; Phone Number: 617-732-6310; Email: dbitterman@bwh.harvard.edu
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Elad Sharon, MD; Phone Number: 617-582-8900; Email: elad_sharon@dfci.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard monitoring; Standard irAE monitoring for an eligible registration event.	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.
Experimental: Informatics-assisted monitoring; Informatics-assisted monitoring plus standard monitoring	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	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.	2 months
Registration	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to data entry	Time to data entry is defined as the time from first evidence of an irAE in the EHR until the data is first entered into the irAE biorespository clinical data management system.	12 months
irAE capture rate	irAE capture rate is defined as the proportion of subjects who experienced a severe irAE that were registered onto the prospective irAE biorepository. The occurrence of a severe irAE will be determined by dual expert clinician review of the EHR of enrolled patients.	12 months

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

Helpful Links

• ClinicalTrials.gov link for the Alliance irAE biorepository (NCT04242095)

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: January 18, 2025
• First Submitted That Met QC Criteria: January 18, 2025
• First Posted (Actual): January 23, 2025

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: malignancy; natural language processing; health informatics; adverse drug event
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: DF/HCC 24-740; R01CA294033 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No