NCT05673018 · GRAIL, Inc.
Galleri® in the Medicare Population.
What this study is about
This multi-center comparative forward-looking group of participants 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- For Galleri + UC (Galleri-Tested Arm): Participants are eligible to be included in the study only if all of the following criteria apply:
- 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). For UC (Not Galleri-tested Arm): Participants are eligible to be included in the study only if all of the following criteria apply:
- Aged ≥ 50 years with Medicare coverage, including Traditional Medicare (Part A \& B or Dual Eligibles) or Medicare Advantage.
- Have had ≥ 1 UC visit
Exclusion criteria
- For Galleri + UC (Galleri-Tested Arm):
- 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):
- Diagnosed ≤3 years before expected enrollment date and/or
- Diagnosed \>3 years before expected enrollment date and never treated and/or
- Currently undergoing active cancer management (not including adjuvant hormone therapy for breast or prostate cancer).
- 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. For UC (Not Galleri-tested Arm):
- 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):
- Diagnosed ≤3 years before expected enrollment date and/or
- Diagnosed \>3 years before expected enrollment date and never treated and/or
- Currently undergoing active cancer management (not including adjuvant hormone therapy for breast or prostate cancer).
- Current pregnancy.
- Individuals who are currently inpatients at a participating site.
Where
- Fort Smith, Arkansas
- Auburn, California
- Davis, California
- Elk Grove, California
- Fountain Valley, California
- Laguna Hills, California
- Long Beach, California
- Modesto, California
- Palo Alto, California
- Roseville, California
- Sacramento, California
- San Francisco, California
And 34 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations