Actively Recruiting
Study of Galleri Blood Test for Early Cancer Detection in Medicare Beneficiaries Aged 50 and Older
Led by GRAIL, Inc. · Updated on 2026-05-22
50000
Participants Needed
61
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the real-world clinical impact of the Galleri4, a blood-based multi-cancer early detection MCED test, in a Medicare population aged 50 years and older. This multi-center prospective cohort study aims to assess the tests safety and performance alongside usual care, enrolling participants representative of Medicare beneficiaries. The study is observational and compares outcomes between those receiving the Galleri test plus usual care and those receiving usual care alone. Participants in the Galleri-tested arm will have blood collected for the MCED test with results returned to guide further evaluation. The comparator group consists of Medicare beneficiaries receiving usual care without the Galleri test. Both groups will be observed over a period of up to 3 years to evaluate cancer incidence and diagnostic outcomes. Throughout the study, researchers will monitor the incidence of stage IV cancers, the number and types of invasive procedures following test results, adherence to recommended cancer screening, and healthcare resource use related to cancer diagnostics. Safety and test performance will be tracked in the Galleri-tested group. Participation involves routine clinical visits and data collection for up to 3 years, with no interventions withheld for either group.
CONDITIONS
Brief Title
Galleri® in the Medicare Population.
Research Team
G
GRAIL Medical Information
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