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Emulation of the SUNLIGHT Trial Using Specialty Oncology Electronic Health Records Databases
Sponsor: Brigham and Women's Hospital
Summary
This observational study uses existing U.S. specialty oncology electronic health records to emulate the SUNLIGHT trial. It compares survival among adults with metastatic colorectal cancer who began trifluridine-tipiracil plus bevacizumab or trifluridine-tipiracil alone after prior systemic treatment. Treatment was chosen during routine care; the study did not assign treatment. The main outcome is time to death from any cause. Investigators will compare the real-world estimate with the published estimate from the randomized SUNLIGHT trial.
Official title: Emulation of the SUNLIGHT (NCT04737187) Trial Using Specialty Oncology Electronic Health Records Databases
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
400
Start Date
2026-09-24
Completion Date
2026-12-24
Last Updated
2026-10-06
Healthy Volunteers
No
Conditions
Interventions
Initiation of trifluridine-tipiracil plus bevacizumab
Initiation of trifluridine-tipiracil (FTD-TPI) plus bevacizumab recorded in electronic health records is the exposure of interest. Treatment was selected in routine care, not assigned by this study.
Initiation of trifluridine-tipiracil alone
Initiation of trifluridine-tipiracil (FTD-TPI) without bevacizumab recorded in electronic health records is the reference exposure. Treatment was selected in routine care, not assigned by this study.
Locations (1)
Brigham and Women's Hospital
Somerville, Massachusetts, United States