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Evaluating Informatics-assisted Immune-related Adverse Event Detection to Improve Registration Onto a Biorepository
NCT06789601 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 929 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06789601 reports 2 study locations spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06789601?
The interventions under investigation include: Informatics system for eligibility monitoring (OTHER), Standard eligibility monitoring (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06789601?
This trial is sponsored by Brigham and Women's Hospital, which has 929 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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