Galleri® in the Medicare Population.

NCT05673018 | Recruiting DMC FDA Device

• 1 other identifier: GRAIL-MA-002
• Study Type: interventional
• Target: 50,000
• Locations: 1 country
• Sites: 47

Brief Summary

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.

Conditions

Cancer

Keywords

ctDNA, Circulating tumor DNA, Screening, Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence rates of stage IV cancers

  Up to 3 Years

Secondary Outcomes (4)

• Safety: Number and type of invasive procedures performed to evaluate a cancer signal detected test result

  Up to 3 Years

• Galleri test performance in the Galleri + UC arm

  Up to 3 Years

• Adherence to guideline-recommended cancer screening in the Galleri+UC arm and UC arm over time

  Up to 3 Years

• Healthcare resource utilization associated with cancer diagnostic evaluations in the Galleri+UC arm and UC arm

  Up to 3 Years

Study Arms (2)

(Galleri + UC)

EXPERIMENTAL

Medicare beneficiaries who receive the Galleri test plus usual care (Galleri + UC).

Device: Multi-Cancer Early Detection Test (Galleri®)

(UC) alone

NO INTERVENTION

Passively-enrolled Contemporaneous Comparator Arm of Medicare beneficiaries who receive usual care (UC) alone.

Interventions

Multi-Cancer Early Detection Test (Galleri®) DEVICE

Blood collection and multi-cancer early detection testing with return of results.

(Galleri + UC)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• For Galleri + UC (Galleri-Tested Arm):
• 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):
• 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

Sponsors & Collaborators

• GRAIL, Inc.: lead

Study Sites (47)

Sutter Valley Hospitals Auburn

Auburn, California, 95603, United States

RECRUITING

Sutter Valley Hospitals Davis

Davis, California, 95616, United States

RECRUITING

Sutter Valley Hospitals Elk Grove

Elk Grove, California, 95758, United States

RECRUITING

Long Beach Memorial Orange Coast

Fountain Valley, California, 92708, United States

RECRUITING

Long Beach Memorial Saddleback

Laguna Hills, California, 92653, United States

RECRUITING

Long Beach Memorial Atlantic

Long Beach, California, 90806, United States

RECRUITING

Sutter Valley Hospitals Modesto

Modesto, California, 95355, United States

RECRUITING

Sutter Valley Hospitals PAMF Sutter

Palo Alto, California, 94301, United States

RECRUITING

Sutter Valley Hospitals Roseville

Roseville, California, 95661, United States

RECRUITING

Sutter Valley Hospitals Alhambra

Sacramento, California, 95816, United States

RECRUITING

Sutter Valley Hospitals Capitol Pavilion

Sacramento, California, 95816, United States

RECRUITING

University of California San Francisco Health System

San Francisco, California, 94158, United States

RECRUITING

Sutter Valley Hospitals Santa Barbara

Santa Barbara, California, 93105, United States

RECRUITING

Sutter Valley Hospitals PAMF Santa Cruz

Santa Cruz, California, 95065, United States

RECRUITING

Sutter Health Santa Rosa

Santa Rosa, California, 95403, United States

RECRUITING

Sutter Valley Hospitals PAMF Sunnyvale

Sunnyvale, California, 94086, United States

RECRUITING

Sutter Valley Hospitals Fairfield

Vallejo, California, 94589, United States

RECRUITING

Morehouse School of Medicine Atlanta

Atlanta, Georgia, 30303, United States

RECRUITING

Morehouse School of Medicine Lee Street

Atlanta, Georgia, 30310, United States

RECRUITING

Morehouse School of Medicine Princeton Lakes

Atlanta, Georgia, 30331, United States

RECRUITING

Morehouse School of Medicine East Point

Atlanta, Georgia, 30344, United States

RECRUITING

Community Health Network Anderson

Anderson, Indiana, 46011, United States

RECRUITING

Community Health Network North

Fishers, Indiana, 46038, United States

RECRUITING

Community Health Network East

Indianapolis, Indiana, 46219, United States

RECRUITING

Community Health Network South

Indianapolis, Indiana, 46256, United States

RECRUITING

Community Health Network Kokomo

Kokomo, Indiana, 46902, United States

RECRUITING

Ochsner Health Bocage

Baton Rouge, Louisiana, 70809, United States

RECRUITING

Ochsner Health Grove

Baton Rouge, Louisiana, 70836, United States

RECRUITING

Ochsner Health Covington

Covington, Louisiana, 70433, United States

RECRUITING

Ochsner Health St. Tammany Parish

Covington, Louisiana, 70433, United States

RECRUITING

Ochsner Health STCC

Covington, Louisiana, 70433, United States

RECRUITING

Ochsner Health Kenner

Kenner, Louisiana, 70065, United States

RECRUITING

Ochsner Health Lafayette

Lafayette, Louisiana, 70503, United States

RECRUITING

Ochsner Health Westbank

Marrero, Louisiana, 70072, United States

RECRUITING

Ochsner Health Lafreniere

Metairie, Louisiana, 70003, United States

RECRUITING

Ochsner Health Benson

New Orleans, Louisiana, 70121, United States

RECRUITING

Mercy Health - Springfield

Springfield, Missouri, 65807, United States

RECRUITING

Mercy Health St. Louis

St Louis, Missouri, 63141, United States

RECRUITING

OHSU CEDAR Clinical Trials Beaverton

Beaverton, Oregon, 97006, United States

RECRUITING

OHSU CEDAR Clinical Trials Orenco

Hillsboro, Oregon, 97124, United States

RECRUITING

OHSU CEDAR Clinical Trials Portland

Portland, Oregon, 97201, United States

RECRUITING

OHSU CEDAR Clinical Trials Richmond

Portland, Oregon, 97202, United States

RECRUITING

Geisinger Bloomsburg Hospital

Bloomsburg, Pennsylvania, 17815, United States

RECRUITING

HCA Healthcare Brentwood

Brentwood, Tennessee, 37027, United States

RECRUITING

HCA Healthcare Centennial

Nashville, Tennessee, 37203, United States

RECRUITING

HCA Healthcare Nashville

Nashville, Tennessee, 37203, United States

RECRUITING

West Virginia University Health System

Morgantown, West Virginia, 26501, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

GRAIL Medical Information

CONTACT

833-694-2553; customerservice@grail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The parallel arm is a passively-enrolled contemporaneous comparator cohort of Medicare beneficiaries who receive usual care without MCED screening.

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: January 5, 2023
• Study Start: July 12, 2024
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (47)