Galleri® in the Medicare Population.

May 19, 2026 updated by: GRAIL, Inc.

REACH Study: Galleri® in the Medicare Population.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arkansas
    • California
      • Auburn, California, United States, 95603
      • Davis, California, United States, 95616
      • Elk Grove, California, United States, 95758
      • Fountain Valley, California, United States, 92708
      • Laguna Hills, California, United States, 92653
      • Long Beach, California, United States, 90806
      • Modesto, California, United States, 95355
      • Palo Alto, California, United States, 94301
      • Roseville, California, United States, 95661
      • Sacramento, California, United States, 95816
      • Sacramento, California, United States, 95816
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California San Francisco Health System
        • Contact:
      • Santa Barbara, California, United States, 93105
      • Santa Cruz, California, United States, 95065
      • Santa Rosa, California, United States, 95403
      • Sunnyvale, California, United States, 94086
      • Vallejo, California, United States, 94589
    • Florida
      • Tampa, Florida, United States, 33612
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Morehouse School of Medicine Atlanta
        • Contact:
      • Atlanta, Georgia, United States, 30310
        • Recruiting
        • Morehouse School of Medicine Lee Street
        • Contact:
      • Atlanta, Georgia, United States, 30331
        • Recruiting
        • Morehouse School of Medicine Princeton Lakes
        • Contact:
      • Atlanta, Georgia, United States, 30344
        • Recruiting
        • Morehouse School of Medicine East Point
        • Contact:
      • Augusta, Georgia, United States, 30909
    • Indiana
      • Anderson, Indiana, United States, 46011
        • Recruiting
        • Community Health Network Anderson
        • Contact:
      • Fishers, Indiana, United States, 46038
        • Recruiting
        • Community Health Network North
        • Contact:
      • Indianapolis, Indiana, United States, 46219
        • Recruiting
        • Community Health Network East
        • Contact:
      • Indianapolis, Indiana, United States, 46256
        • Recruiting
        • Community Health Network South
        • Contact:
      • Kokomo, Indiana, United States, 46902
        • Recruiting
        • Community Health Network Kokomo
        • Contact:
      • Kokomo, Indiana, United States, 46902
        • Recruiting
        • Community Health Network LaFountain
        • Contact:
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
      • Baton Rouge, Louisiana, United States, 70836
      • Covington, Louisiana, United States, 70433
      • Covington, Louisiana, United States, 70433
        • Recruiting
        • Ochsner Health St. Tammany Parish
        • Contact:
      • Covington, Louisiana, United States, 70433
      • Kenner, Louisiana, United States, 70065
      • Lafayette, Louisiana, United States, 70503
      • Marrero, Louisiana, United States, 70072
      • Metairie, Louisiana, United States, 70003
      • New Orleans, Louisiana, United States, 70121
      • New Orleans, Louisiana, United States, 70115
    • Missouri
    • Oregon
      • Astoria, Oregon, United States, 97103
        • Recruiting
        • OHSU CEDAR Clinical Trials Columbia
        • Contact:
      • Astoria, Oregon, United States, 97103
        • Recruiting
        • OHSU CEDAR Clinical Trials Exchange
        • Contact:
      • Beaverton, Oregon, United States, 97006
        • Recruiting
        • OHSU CEDAR Clinical Trials Beaverton
        • Contact:
      • Hillsboro, Oregon, United States, 97124
        • Recruiting
        • OHSU CEDAR Clinical Trials Orenco
        • Contact:
      • Hood River, Oregon, United States, 97031
        • Recruiting
        • OHSU CEDAR Clinical Trials Woods
        • Contact:
      • Portland, Oregon, United States, 97201
        • Recruiting
        • OHSU CEDAR Clinical Trials Portland
        • Contact:
      • Portland, Oregon, United States, 97202
        • Recruiting
        • OHSU CEDAR Clinical Trials Richmond
        • Contact:
      • The Dalles, Oregon, United States, 97058
        • Recruiting
        • OHSU CEDAR Clinical Trials Adventist
        • Contact:
      • The Dalles, Oregon, United States, 97058
        • Recruiting
        • OHSU CEDAR Clinical Trials Dalles
        • Contact:
      • Warrenton, Oregon, United States, 97146
        • Recruiting
        • OHSU CEDAR Clinical Trials Ensign
        • Contact:
    • Pennsylvania
      • Bloomsburg, Pennsylvania, United States, 17815
        • Recruiting
        • Geisinger Bloomsburg Hospital - Bloomsburg
        • Contact:
    • Tennessee
      • Brentwood, Tennessee, United States, 37027
      • Nashville, Tennessee, United States, 37203
      • Nashville, Tennessee, United States, 37203
    • Utah
      • Salt Lake City, Utah, United States, 84124
    • West Virginia
      • Buckhannon, West Virginia, United States, 26201
        • Recruiting
        • West Virginia University Health System St. Joseph
        • Contact:
      • Morgantown, West Virginia, United States, 26501
        • Recruiting
        • West Virginia University Health System Morgantown
        • Contact:
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University Health System WV CTSI
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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):

    1. Diagnosed ≤3 years before expected enrollment date and/or
    2. Diagnosed >3 years before expected enrollment date and never treated and/or
    3. 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):

    1. Diagnosed ≤3 years before expected enrollment date and/or
    2. Diagnosed >3 years before expected enrollment date and never treated and/or
    3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: (Galleri + UC)
Medicare beneficiaries who receive the Galleri test plus usual care (Galleri + UC).
Device: Multi-Cancer Early Detection Test (Galleri®)
Blood collection and multi-cancer early detection testing with return of results.
No Intervention: (UC) alone
Passively-enrolled Contemporaneous Comparator Arm of Medicare beneficiaries who receive usual care (UC) alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence rates of stage IV cancers
Time Frame: Up to 3 Years
Up to 3 Years

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety: Number and type of invasive procedures performed to evaluate a cancer signal detected test result
Time Frame: Up to 3 Years
Up to 3 Years
Galleri test performance in the Galleri + UC arm
Time Frame: Up to 3 Years
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
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
Up to 3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GRAIL, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2024

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

December 7, 2022

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Actual)

January 5, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRAIL-MA-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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