Galleri® in the Medicare Population.

Conditions

• Cancer

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Multi-Cancer Early Detection Test (Galleri®) — DEVICE
  Blood collection and multi-cancer early detection testing with return of results.

Study Details

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.

Key Dates

Start date

Jul 12, 2024

Status verified

May 2026

Primary completion

Sep 30, 2030

Completion

Sep 30, 2030

Study Design

Enrollment

50,000 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Arms

• Experimental: (Galleri + UC)
  Medicare beneficiaries who receive the Galleri test plus usual care (Galleri + UC).
• No Intervention: (UC) alone
  Passively-enrolled Contemporaneous Comparator Arm of Medicare beneficiaries who receive usual care (UC) alone.

Primary Outcome Measure

Incidence rates of stage IV cancers [ Time Frame: Up to 3 Years ]

Central Contacts

• GRAIL Medical Information
  833-694-2553
  [email protected]

Locations (61)

Find similar trials in Fort Smith, AR

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