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NCT06789601 · ClinicalTrials.gov registry record · Phase 1
Evaluating Informatics-assisted Immune-related Adverse Event Detection to Improve Registration Onto a Biorepository
A Phase 1 study of Malignancy and Immune Related Adverse Events, sponsored by Brigham and Women's Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 2
- Study locations
NCT06789601 is a Phase 1 study of Malignancy and Immune Related Adverse Events that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 100 participants, below the 12,575-participant average among 8 other Malignancy trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT06789601, a Phase 1 study of Malignancy and Immune Related Adverse Events, is actively recruiting participants, sponsored by Brigham and Women's Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 2
- Study locations
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 Studied
Interventions
- OTHER Informatics system for eligibility monitoring
- OTHER Standard eligibility monitoring
Study Locations (2)
Massachusetts
- Brigham and Women's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-06-17 |
| Est. Completion | 2027-08-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06789601
The ClinicalTrials.gov registry entry for NCT06789601 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,575-participant average among 8 other Malignancy trials with a reported enrollment target (99% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Malignancy appearing as the primary indexed condition, and to 2 interventions - of which Informatics system for eligibility monitoring is the first listed.
NCT06789601 reports 2 study locations spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06789601 about?
NCT06789601 is a clinical study titled "Evaluating Informatics-assisted Immune-related Adverse Event Detection to Improve Registration Onto a Biorepository". 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 ...
What is the current status of trial NCT06789601?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2025-06-17. Estimated completion is 2027-08-31.
What conditions does trial NCT06789601 study?
This clinical trial studies the following conditions: Malignancy, Immune Related Adverse Events.
What interventions are being tested in trial NCT06789601?
The interventions under investigation include: Informatics system for eligibility monitoring (OTHER), Standard eligibility monitoring (OTHER).
Who is sponsoring clinical trial NCT06789601?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06789601 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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