MalignancyPhase 1/2NCT06789601
Evaluating Informatics-assisted Immune-related Adverse Event Detection to Improve Registration Onto a Biorepository
A Phase 1/2 study testing Informatics system for eligibility monitoring and Standard eligibility monitoring in people with Malignancy and Immune Related Adverse Events, run by Brigham and Women's Hospital at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignancy, Immune Related Adverse Events
- What is being tested?
- Informatics system for eligibility monitoring and Standard eligibility monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jun 2025to 31 Aug 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Received or receiving a regimen containing one or more immuno-oncology therapeutics
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Danielle Bitterman, MD, 617-732-6310, dbitterman@bwh.harvard.edu
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Elad Sharon, MD, 617-582-8900, elad_sharon@dfci.harvard.edu
About this study
Official title: 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?
Read more
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.
Read the 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:
- To establish the feasibility of implementing the informatics system for daily inferencing on EHR data
- To assess the ability of automated irAE detection to improve registration to a prospective irAE biorepository
Our secondary objectives are:
- To evaluate whether automated irAE detection reduces the time to data entry in a prospective biorepository data management system
- 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.
- Conditions
- Malignancy, Immune Related Adverse Events
- Being tested
- Informatics system for eligibility monitoring, Standard eligibility monitoring
- Keywords
- malignancy, adverse drug event, health informatics, natural language processing
- Medical subject headings
- Neoplasms, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Standard eligibility monitoringOther
Reporting of an eligible event to the biorepository study staff by the treating clinician and EHR review by the study staff.
| Study group | Role | What they receive |
|---|---|---|
| Standard monitoring | Other | Standard irAE monitoring for an eligible registration event. Receives: Other: Standard eligibility monitoring |
| Informatics-assisted monitoring | Experimental | Informatics-assisted monitoring plus standard monitoring Receives: Other: Informatics system for eligibility monitoring; Other: Standard eligibility monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start17 Jun 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalignancyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Danielle Bitterman, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789601
- Sponsor's protocol ID
- DF/HCC 24-740
- Other IDs
- R01CA294033
- Status last verified
- Jun 2025
- First submitted
- 18 Jan 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional Pragmatic Clinical Trial of NLP Models for the Detection of Immune-Related Adverse Events
- ClinicalTrials.gov ID
- NCT06789601
- Acronym / sponsor ID
- DF/HCC 24-740
- Conditions
- Malignancy, Immune Related Adverse Events
- Keywords
- malignancy, adverse drug event, health informatics, natural language processing
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- To establish the feasibility of implementing the informatics system for daily inferencing on EHR data
- To assess the ability of automated irAE detection to improve registration to a prospective irAE biorepository
Our secondary objectives are:
- To evaluate whether automated irAE detection reduces the time to data entry in a prospective biorepository data management system
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard monitoring | Other | Other: Standard eligibility monitoringStandard irAE monitoring for an eligible registration event. |
| Informatics-assisted monitoring | Experimental | Other: Informatics system for eligibility monitoring, Other: Standard eligibility monitoringInformatics-assisted monitoring plus standard monitoring |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Received or receiving a regimen containing one or more immuno-oncology therapeutics
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Informatics system for eligibility monitoringA 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. | Other | Informatics-assisted monitoring |
| Standard eligibility monitoringReporting of an eligible event to the biorepository study staff by the treating clinician and EHR review by the study staff. | Other | Informatics-assisted monitoring, Standard monitoring |
Primary outcome
Feasibility
Time frame: 2 months
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.
Registration
Time frame: 12 months
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.
2 secondary outcomes
Time to data entry
Time frame: 12 months
irAE capture rate
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- ClinicalTrials.gov link for the Alliance irAE biorepository (NCT04242095)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Informatics system for eligibility monitoring and Standard eligibility monitoring in people with Malignancy and Immune Related Adverse Events, run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danielle Bitterman, MD (617-632-5734, dbitterman@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.