Reviewing a New System to Detect Side Effects from Immunotherapy
NCT06789601 · RecruitingThis study looks at how an informatics system can help detect side effects from immunotherapy. Immunotherapy can improve cancer treatment, but it can also cause unique side effects called immune-related adverse events (irAEs). The goal is to see if using a system that analyzes electronic health records can make it easier to find and register patients who are experiencing these side effects to a biorepository. Researchers will compare traditional monitoring methods to this new technology to see which is better at improving registration rates and efficiency.
Locations and contact
This trial is running at 2 locations in the United States. All of them are currently recruiting.
United States2 locations · 2 recruiting
- Brigham and Women's HospitalBoston, MassachusettsRecruiting
- Dana-Farber Cancer InstituteBoston, MassachusettsRecruiting
Who can join
This study is open to all ages, including children, adults, and older adults. Anyone who has received or is receiving immunotherapy can join. The trial is not open to healthy volunteers. The trial team will confirm who can participate.
What happens during the trial
Participants will be randomly placed into two groups. One group will receive standard monitoring for side effects. The other group will use the new informatics-assisted monitoring system along with standard monitoring. Everyone's health records will be reviewed to collect information about their health and cancer treatment. Participants will be monitored for up to 12 months or until they register in the biorepository.
The trial team
The trial is sponsored by Brigham and Women's Hospital. The principal investigator is leading the study with collaboration from the National Cancer Institute.
Important dates
The trial started on June 17, 2025, and is expected to finish by August 31, 2027. It is currently recruiting new participants.
Additional information
The trial's ID number is NCT06789601. This is a Phase 1 and Phase 2 trial, which means it is looking at how well the system works and how safe it is. It is not for drugs or devices regulated by the FDA. The study hopes to include about 100 participants.
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