NCT06789601

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
16mo left

Started Jun 2025

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Jun 2025Aug 2027

First Submitted

Initial submission to the registry

January 18, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

June 17, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

2.2 years

First QC Date

January 18, 2025

Last Update Submit

June 17, 2025

Conditions

MalignancyImmune Related Adverse Events

Keywords

malignancyadverse drug eventhealth informaticsnatural language processing

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Time to data entry

    12 months

  • irAE capture rate

    12 months

Study Arms (2)

Standard monitoring

OTHER

Standard irAE monitoring for an eligible registration event.

Other: Standard eligibility monitoring

Informatics-assisted monitoring

EXPERIMENTAL

Informatics-assisted monitoring plus standard monitoring

Other: Informatics system for eligibility monitoringOther: Standard eligibility monitoring

Interventions

Informatics system for eligibility monitoringOTHER

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.

Informatics-assisted monitoring
Standard eligibility monitoringOTHER

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

Informatics-assisted monitoringStandard monitoring

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

Related Links

MeSH Terms

Conditions

NeoplasmsDrug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Central Study Contacts

Danielle Bitterman, MD

CONTACT

617-632-5734dbitterman@bwh.harvard.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician Investigator

Study Record Dates

First Submitted

January 18, 2025

First Posted

January 23, 2025

Study Start

June 17, 2025

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

June 19, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)