Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study of Malignancy and Immune Related Adverse Events, sponsored by Brigham and Women's Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What NCT06789601 shows while recruiting
NCT06789601 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 12,575-participant average among 8 other Malignancy trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Malignancy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06789601's enrollment target sits among peer trials
100 4th of 8 higher than 5 of 8 other Malignancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignancy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal
COMPLETED · Phase 1
-
Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials
RECRUITING · NA
-
BostonGene-Integrated Genomic Registry (BIGR)
RECRUITING
-
Collection of Research Data and Samples From Patients Who Experience Immunotherapy Side Effects
RECRUITING
-
Immuno-Oncology Database and Bioregistry
ACTIVE NOT RECRUITING
-
Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01048281 · 100 participants
Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma
- NCT01161199 · 100 participants
The Use of Leukapheresis to Support HIV Pathogenesis Studies
- NCT01327690 · 100 participants · Early Phase 1
Mental Health in Veterans and Families After Group Therapies
- NCT01730781 · 100 participants
Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI