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Galleri® Multi-Cancer Early Detection Test in Medicare Population

This study is looking at how well the Galleri® test, a blood test designed to find many types of cancer early, works in real-world settings for people with Medicare. Researchers want to see if using Galleri® can help reduce the number of advanced (stage IV) cancers found over three years. You might be able to join if you are 50 years or older and have Medicare coverage. The study aims to include 50,000 participants to get a good understanding of the test's impact.

Study design
This is a large study involving 50,000 participants. It compares people who receive the Galleri® test with those who don't, to see the real-world effects.
What's involved
Participants will have a blood collection for the Galleri® test and receive their results. The study will track health outcomes for up to three years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to three years to measure the incidence of stage IV cancers.

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NCT05673018

Galleri® in the Medicare Population.

Recruiting
NAAges 50+InterventionalScreening
GRAIL, Inc.
~50,000 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Multi-Cancer Early Detection Test (Galleri®)

At a glance

Recruiting sites
61 of 61 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence rates of stage IV cancers
Measured over Up to 3 Years

Conditions

Cancer

Explore related trials

Malignant Neoplasm

Where it's being run

61 sites across 12 states
California17
Louisiana11
Oregon10
Indiana6
Georgia5
Tennessee3
West Virginia3
Missouri2

Who to contact

GRAIL Medical Information
[email protected]
833-694-2553
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Aged ≥50 years with Medicare coverage, including Traditional Medicare (Part A \& B or Dual Eligibles) or Medicare Advantage.
Capable of giving informed consent that is legally effective (consent provided by a legally authorized representative is not permitted in this protocol).
Aged ≥ 50 years with Medicare coverage, including Traditional Medicare (Part A \& B or Dual Eligibles) or Medicare Advantage.
Have had ≥ 1 UC visit

Exclusion

Evidence of having had a previous MCED test (including but not limited to the Galleri test, e.g. CancerSeek, PanSeer). Participation in a study such as GRAIL's STRIVE study where results were not returned is not an exclusion criterion.
Undergoing clinical evaluation for suspicion of cancer within 6 months prior to enrollment. Personal history of hematologic malignancy and/or invasive solid tumor (excluding non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin):
Current pregnancy.
Individuals who are currently inpatients at a participating site.
Individuals who are not willing or able to comply with the protocol procedures.
Individuals who are not currently registered patients at a participating center.
Previous or current employees or contractors of GRAIL.
Evidence of having had a previous MCED test (including but not limited to the Galleri test, eg.CancerSeek, PanSeer). Participation in a study such as GRAIL's STRIVE study where results were not returned is not an exclusion criterion.
Undergoing clinical evaluation for suspicion of cancer.
Personal history of hematologic malignancy and/or invasive solid tumor (not including non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin):
Current pregnancy.
Individuals who are currently inpatients at a participating site.

What this trial measures

  • Incidence rates of stage IV cancersUp to 3 Years