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RecruitingInterventional

REACH Study: Galleri® in the Medicare Population.

NCT ID: NCT05673018Sponsor: GRAIL, Inc.Last updated: 2026-05-22

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.

Arms & interventions

  • DeviceMulti-Cancer Early Detection Test (Galleri®)

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

Outcome measures

Primary

  • Incidence rates of stage IV cancers

    Time frame: Up to 3 Years

Secondary

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

    Time frame: Up to 3 Years

  • Galleri test performance in the Galleri + UC arm

    Time frame: 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

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

    Time frame: Up to 3 Years

Eligibility criteria

Sex: AllAge: 50 Years and olderHealthy volunteers: Yes
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 locations (61)

Mercy Health - Fort Smith

Fort Smith, Arkansas, 72903

Recruiting
Damon Broyles · Contact
MercyResearchREACHStudy@Mercy.net

Sutter Valley Hospitals Auburn

Auburn, California, 95603

Recruiting
Debbie A Jacobs · Contact
916-746-2161clinicalresearch@sutterhealth.org

Sutter Valley Hospitals Davis

Davis, California, 95616

Recruiting
Debbie A Jacobs · Contact
916-746-2161clinicalresearch@sutterhealth.org

Sutter Valley Hospitals Elk Grove

Elk Grove, California, 95758

Recruiting
Debbie A Jacobs · Contact
916-746-2161clinicalresearch@sutterhealth.org

Long Beach Memorial Orange Coast

Fountain Valley, California, 92708

Recruiting
Ana Fuentes · Contact
562-760-6849Afuentes1@memorialcare.org

Long Beach Memorial Saddleback

Laguna Hills, California, 92653

Recruiting
Ana Fuentes · Contact
562-760-6849Afuentes1@memorialcare.org

Long Beach Memorial Atlantic

Long Beach, California, 90806

Recruiting
Ana Fuentes · Contact
562-760-6849Afuentes1@memorialcare.org

Sutter Valley Hospitals Modesto

Modesto, California, 95355

Recruiting
Debbie A Jacobs · Contact
916-746-2161clinicalresearch@sutterhealth.org

Sutter Valley Hospitals PAMF Sutter

Palo Alto, California, 94301

Recruiting
Debbie A Jacobs · Contact
916-746-2161clinicalresearch@sutterhealth.org

Sutter Valley Hospitals Roseville

Roseville, California, 95661

Recruiting
Debbie A Jacobs · Contact
916-746-2161clinicalresearch@sutterhealth.org

Sutter Valley Hospitals Alhambra

Sacramento, California, 95816

Recruiting
Debbie A Jacobs · Contact
916-746-2161clinicalresearch@sutterhealth.org

Sutter Valley Hospitals Capitol Pavilion

Sacramento, California, 95816

Recruiting
Debbie A Jacobs · Contact
916-746-2161clinicalresearch@sutterhealth.org

University of California San Francisco Health System

San Francisco, California, 94158

Recruiting
Corinne Sears · Contact
415-205-0182REACHMCD@ucsf.edu

Sutter Valley Hospitals Santa Barbara

Santa Barbara, California, 93105

Recruiting
Debbie A Jacobs · Contact
916-746-2161clinicalresearch@sutterhealth.org

Sutter Valley Hospitals PAMF Santa Cruz

Santa Cruz, California, 95065

Recruiting
Debbie A Jacobs · Contact
916-746-2161clinicalresearch@sutterhealth.org

Sutter Health Santa Rosa

Santa Rosa, California, 95403

Recruiting
Debbie A Jacobs · Contact
916-746-2161clinicalresearch@sutterhealth.org

Sutter Valley Hospitals PAMF Sunnyvale

Sunnyvale, California, 94086

Recruiting
Debbie A Jacobs · Contact
916-746-2161clinicalresearch@sutterhealth.org

Sutter Valley Hospitals Fairfield

Vallejo, California, 94589

Recruiting
Debbie A Jacobs · Contact
916-746-2161clinicalresearch@sutterhealth.org

USF Morsani Center for Advanced Healthcare

Tampa, Florida, 33612

Recruiting
Dusan Nikolic · Contact
clinicalresearch@usf.edu

Morehouse School of Medicine Atlanta

Atlanta, Georgia, 30303

Recruiting
LaTrisha Horne · Contact
404-789-3825lhorne@msm.edu

Morehouse School of Medicine Lee Street

Atlanta, Georgia, 30310

Recruiting
LaTrisha Horne · Contact
404-789-3825lhorne@msm.edu

Morehouse School of Medicine Princeton Lakes

Atlanta, Georgia, 30331

Recruiting
LaTrisha Horne · Contact
404-789-3825lhorne@msm.edu

Morehouse School of Medicine East Point

Atlanta, Georgia, 30344

Recruiting
LaTrisha Horne · Contact
404-789-3825lhorne@msm.edu

HCA Healthcare Doctors Hospital

Augusta, Georgia, 30909

Recruiting
Kellie Graves · Contact
615-507-2247Kellie.Graves@hcahealthcare.com

Community Health Network Anderson

Anderson, Indiana, 46011

Recruiting
Allison Landis · Contact
317-621-7724Alandis@ecommunity.com

Community Health Network North

Fishers, Indiana, 46038

Recruiting
Allison Landis · Contact
317-621-7724Alandis@ecommunity.com

Community Health Network East

Indianapolis, Indiana, 46219

Recruiting
Allison Landis · Contact
317-621-7724Alandis@ecommunity.com

Community Health Network South

Indianapolis, Indiana, 46256

Recruiting
Allison Landis · Contact
317-621-7724Alandis@ecommunity.com

Community Health Network Kokomo

Kokomo, Indiana, 46902

Recruiting
Allison Landis · Contact
317-621-7724Alandis@ecommunity.com

Community Health Network LaFountain

Kokomo, Indiana, 46902

Recruiting
Allison Landis · Contact
317-621-7724Alandis@ecommunity.com

Ochsner Health Bocage

Baton Rouge, Louisiana, 70809

Recruiting
Ellen Lovell · Contact
504-842-8196Ellen.Lovell@Ochsner.org

Ochsner Health Grove

Baton Rouge, Louisiana, 70836

Recruiting
Ellen Lovell · Contact
504-842-8196Ellen.Lovell@Ochsner.org

Ochsner Health Covington

Covington, Louisiana, 70433

Recruiting
Ellen Lovell · Contact
504-842-8196Ellen.Lovell@Ochsner.org

Ochsner Health St. Tammany Parish

Covington, Louisiana, 70433

Recruiting
Ellen Lovell · Contact
504-842-8196Ellen.Lovell@Ochsner.org

Ochsner Health STCC

Covington, Louisiana, 70433

Recruiting
Ellen Lovell · Contact
504-842-8196Ellen.Lovell@Ochsner.org

Ochsner Health Kenner

Kenner, Louisiana, 70065

Recruiting
Ellen Lovell · Contact
504-842-8196Ellen.Lovell@Ochsner.org

Ochsner Health Lafayette

Lafayette, Louisiana, 70503

Recruiting
Ellen Lovell · Contact
504-842-8196Ellen.Lovell@Ochsner.org

Ochsner Health Westbank

Marrero, Louisiana, 70072

Recruiting
Ellen Lovell · Contact
504-842-8196Ellen.Lovell@Ochsner.org

Ochsner Health Lafreniere

Metairie, Louisiana, 70003

Recruiting
Ellen Lovell · Contact
504-842-8196Ellen.Lovell@Ochsner.org

Ochsner Health Baptist

New Orleans, Louisiana, 70115

Recruiting
Ellen Lovell · Contact
504-842-8196Ellen.Lovell@Ochsner.org

Ochsner Health Benson

New Orleans, Louisiana, 70121

Recruiting
Ellen Lovell · Contact
504-842-8196Ellen.Lovell@Ochsner.org

Mercy Health - Springfield

Springfield, Missouri, 65807

Recruiting
Damon Broyles · Contact
MercyResearchREACHStudy@Mercy.net

Mercy Health St. Louis

St Louis, Missouri, 63141

Recruiting
Damon Broyles · Contact
MercyResearchREACHStudy@Mercy.net

OHSU CEDAR Clinical Trials Columbia

Astoria, Oregon, 97103

Recruiting
Laura Ferrara · Contact
541-645-3276REACH@ohsu.edu

OHSU CEDAR Clinical Trials Exchange

Astoria, Oregon, 97103

Recruiting
Laura Ferrara · Contact
541-645-3276REACH@ohsu.edu

OHSU CEDAR Clinical Trials Beaverton

Beaverton, Oregon, 97006

Recruiting
Diana Potts · Contact
503-418-8150REACH@ohsu.edu

OHSU CEDAR Clinical Trials Orenco

Hillsboro, Oregon, 97124

Recruiting
Diana Potts · Contact
503-418-8150REACH@ohsu.edu

OHSU CEDAR Clinical Trials Woods

Hood River, Oregon, 97031

Recruiting
Laura Ferrara · Contact
541-645-3276REACH@ohsu.edu

OHSU CEDAR Clinical Trials Portland

Portland, Oregon, 97201

Recruiting
Diana Potts · Contact
503-418-8150REACH@ohsu.edu

OHSU CEDAR Clinical Trials Richmond

Portland, Oregon, 97202

Recruiting
Diana Potts · Contact
503-418-8150REACH@ohsu.edu

OHSU CEDAR Clinical Trials Adventist

The Dalles, Oregon, 97058

Recruiting
Laura Ferrara · Contact
541-645-3276REACHstudy@ohsu.edu

OHSU CEDAR Clinical Trials Dalles

The Dalles, Oregon, 97058

Recruiting
Laura Ferrara · Contact
541-645-3276REACH@ohsu.edu

OHSU CEDAR Clinical Trials Ensign

Warrenton, Oregon, 97146

Recruiting
Laura Ferrara · Contact
541-645-3276REACH@ohsu.edu

Geisinger Bloomsburg Hospital - Bloomsburg

Bloomsburg, Pennsylvania, 17815

Recruiting
Ashley Honushefsky · Contact
570-293-7170reachstudy@geisinger.edu

HCA Healthcare Brentwood

Brentwood, Tennessee, 37027

Recruiting
Kellie Graves · Contact
615-507-2247Kellie.Graves@hcahealthcare.com

HCA Healthcare Centennial

Nashville, Tennessee, 37203

Recruiting
Kellie Graves · Contact
615-507-2247Kellie.Graves@hcahealthcare.com

HCA Healthcare Nashville

Nashville, Tennessee, 37203

Recruiting
Kellie Graves · Contact
615-507-2247Kellie.Graves@hcahealthcare.com

HCA Healthcare St. Marks

Salt Lake City, Utah, 84124

Recruiting
Kellie Graves · Contact
615-507-2247Kellie.Graves@hcahealthcare.com

West Virginia University Health System St. Joseph

Buckhannon, West Virginia, 26201

Recruiting
Courtney Pilkerton · Contact
304-285-7250DFMresearch@wvumedicine.org

West Virginia University Health System Morgantown

Morgantown, West Virginia, 26501

Recruiting
Courtney Pilkerton · Contact
304-285-7250DFMresearch@wvumedicine.org

West Virginia University Health System WV CTSI

Morgantown, West Virginia, 26506

Recruiting
Courtney Pilkerton · Contact
304-285-7250DFMresearch@wvumedicine.org