Recruiting

Galleri

Sponsor:

GRAIL, Inc.

Code:

NCT05673018

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

Multi-Cancer Early Detection Test (Galleri®)

Study Details

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

Study ID

NCT05673018

Start date

Jul 12, 2024

Status verified date

May, 2026

Completion date

Sep, 2030

Anticipated

Primary completion date

Sep, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

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 Design

Enrollment

50000 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

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.

Interventions

Multi-Cancer Early Detection Test (Galleri®)

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Mercy Health - Fort Smith

Recruiting

Fort Smith, Arkansas, United States, 72903

Contacts

Sutter Valley Hospitals Auburn

Recruiting

Auburn, California, United States, 95603

Contacts

Sutter Valley Hospitals Davis

Recruiting

Davis, California, United States, 95616

Contacts

Sutter Valley Hospitals Elk Grove

Recruiting

Elk Grove, California, United States, 95758

Contacts

Long Beach Memorial Orange Coast

Recruiting

Fountain Valley, California, United States, 92708

Contacts

Long Beach Memorial Saddleback

Recruiting

Laguna Hills, California, United States, 92653

Contacts

Long Beach Memorial Atlantic

Recruiting

Long Beach, California, United States, 90806

Contacts

Sutter Valley Hospitals Modesto

Recruiting

Modesto, California, United States, 95355

Contacts

Sutter Valley Hospitals PAMF Sutter

Recruiting

Palo Alto, California, United States, 94301

Contacts

Sutter Valley Hospitals Roseville

Recruiting

Roseville, California, United States, 95661

Contacts

Sutter Valley Hospitals Alhambra

Recruiting

Sacramento, California, United States, 95816

Contacts

Sutter Valley Hospitals Capitol Pavilion

Recruiting

Sacramento, California, United States, 95816

Contacts

University of California San Francisco Health System

Recruiting

San Francisco, California, United States, 94158

Contacts

Sutter Valley Hospitals Santa Barbara

Recruiting

Santa Barbara, California, United States, 93105

Contacts

Sutter Valley Hospitals PAMF Santa Cruz

Recruiting

Santa Cruz, California, United States, 95065

Contacts

Sutter Health Santa Rosa

Recruiting

Santa Rosa, California, United States, 95403

Contacts

Sutter Valley Hospitals PAMF Sunnyvale

Recruiting

Sunnyvale, California, United States, 94086

Contacts

Sutter Valley Hospitals Fairfield

Recruiting

Vallejo, California, United States, 94589

Contacts

USF Morsani Center for Advanced Healthcare

Recruiting

Tampa, Florida, United States, 33612

Contacts

Morehouse School of Medicine Atlanta

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Morehouse School of Medicine Lee Street

Recruiting

Atlanta, Georgia, United States, 30310

Contacts

Morehouse School of Medicine Princeton Lakes

Recruiting

Atlanta, Georgia, United States, 30331

Contacts

Morehouse School of Medicine East Point

Recruiting

Atlanta, Georgia, United States, 30344

Contacts

HCA Healthcare Doctors Hospital

Recruiting

Augusta, Georgia, United States, 30909

Contacts

Community Health Network Anderson

Recruiting

Anderson, Indiana, United States, 46011

Contacts

Community Health Network North

Recruiting

Fishers, Indiana, United States, 46038

Contacts

Community Health Network East

Recruiting

Indianapolis, Indiana, United States, 46219

Contacts

Community Health Network South

Recruiting

Indianapolis, Indiana, United States, 46256

Contacts

Community Health Network Kokomo

Recruiting

Kokomo, Indiana, United States, 46902

Contacts

Community Health Network LaFountain

Recruiting

Kokomo, Indiana, United States, 46902

Contacts

Ochsner Health Bocage

Recruiting

Baton Rouge, Louisiana, United States, 70809

Contacts

Ochsner Health Grove

Recruiting

Baton Rouge, Louisiana, United States, 70836

Contacts

Ochsner Health Covington

Recruiting

Covington, Louisiana, United States, 70433

Contacts

Ochsner Health St. Tammany Parish

Recruiting

Covington, Louisiana, United States, 70433

Contacts

Ochsner Health STCC

Recruiting

Covington, Louisiana, United States, 70433

Contacts

Ochsner Health Kenner

Recruiting

Kenner, Louisiana, United States, 70065

Contacts

Ochsner Health Lafayette

Recruiting

Lafayette, Louisiana, United States, 70503

Contacts

Ochsner Health Westbank

Recruiting

Marrero, Louisiana, United States, 70072

Contacts

Ochsner Health Lafreniere

Recruiting

Metairie, Louisiana, United States, 70003

Contacts

Ochsner Health Baptist

Recruiting

New Orleans, Louisiana, United States, 70115

Contacts

Ochsner Health Benson

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Mercy Health - Springfield

Recruiting

Springfield, Missouri, United States, 65807

Contacts

Mercy Health St. Louis

Recruiting

St Louis, Missouri, United States, 63141

Contacts

OHSU CEDAR Clinical Trials Columbia

Recruiting

Astoria, Oregon, United States, 97103

Contacts

OHSU CEDAR Clinical Trials Exchange

Recruiting

Astoria, Oregon, United States, 97103

Contacts

OHSU CEDAR Clinical Trials Beaverton

Recruiting

Beaverton, Oregon, United States, 97006

Contacts

OHSU CEDAR Clinical Trials Orenco

Recruiting

Hillsboro, Oregon, United States, 97124

Contacts

OHSU CEDAR Clinical Trials Woods

Recruiting

Hood River, Oregon, United States, 97031

Contacts

OHSU CEDAR Clinical Trials Portland

Recruiting

Portland, Oregon, United States, 97201

Contacts

OHSU CEDAR Clinical Trials Richmond

Recruiting

Portland, Oregon, United States, 97202

Contacts

OHSU CEDAR Clinical Trials Adventist

Recruiting

The Dalles, Oregon, United States, 97058

Contacts

OHSU CEDAR Clinical Trials Dalles

Recruiting

The Dalles, Oregon, United States, 97058

Contacts

OHSU CEDAR Clinical Trials Ensign

Recruiting

Warrenton, Oregon, United States, 97146

Contacts

Geisinger Bloomsburg Hospital - Bloomsburg

Recruiting

Bloomsburg, Pennsylvania, United States, 17815

Contacts

HCA Healthcare Brentwood

Recruiting

Brentwood, Tennessee, United States, 37027

Contacts

HCA Healthcare Centennial

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

HCA Healthcare Nashville

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

HCA Healthcare St. Marks

Recruiting

Salt Lake City, Utah, United States, 84124

Contacts

West Virginia University Health System St. Joseph

Recruiting

Buckhannon, West Virginia, United States, 26201

Contacts

West Virginia University Health System Morgantown

Recruiting

Morgantown, West Virginia, United States, 26501

Contacts

West Virginia University Health System WV CTSI

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

More Information

Sponsor

GRAIL, Inc.

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • ctDNA, Circulating tumor DNA, Screening, Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by GRAIL, Inc. on 2026-05-22.