This multi-center comparative prospective cohort study is designed to assess the real world clinical impact, including safety and test performance, of Galleri®, a blood-based multi-cancer early detection (MCED) test. The study will seek enrollment that is representative of the Medicare population.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
50,000
Blood collection and multi-cancer early detection testing with return of results.
Incidence rates of stage IV cancers
Time frame: Up to 3 Years
Safety: Number and type of invasive procedures performed to evaluate a cancer signal detected test result
Time frame: Up to 3 Years
Galleri test performance in the Galleri + UC arm
Time frame: Up to 3 Years
Adherence to guideline-recommended cancer screening in the Galleri+UC arm and UC arm over time
Time frame: Up to 3 Years
Healthcare resource utilization associated with cancer diagnostic evaluations in the Galleri+UC arm and UC arm
Time frame: Up to 3 Years
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