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CancerNCT05673018

Galleri® in the Medicare Population.

A study testing Multi-Cancer Early Detection Test (Galleri®) in people with Cancer, run by GRAIL, Inc. at 72 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Cancer
What is being tested?
Multi-Cancer Early Detection Test (Galleri®)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50,000 participants
Where
72 sitesUnited States
Study dates
12 Jul 2024to Sep 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).
Show all 20Show fewer
  • 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.

Trial locations and contacts

72 sites in 1 country. Contact the study team or a site near you to ask about taking part.

GRAIL Medical Information contact

833-694-2553

customerservice@grail.com

72 sites in 1 country

United States72 sites, 71 recruiting
  • Community Health Network Anderson

    Anderson, Indiana, 46011

    Allison Landis, 317-621-7724, Alandis@ecommunity.com

    Recruiting
  • OHSU CEDAR Clinical Trials Columbia

    Astoria, Oregon, 97103

    Laura Ferrara, 541-645-3276, REACH@ohsu.edu

    Recruiting
  • OHSU CEDAR Clinical Trials Exchange

    Astoria, Oregon, 97103

    Laura Ferrara, 541-645-3276, REACH@ohsu.edu

    Recruiting
  • Morehouse School of Medicine Atlanta

    Atlanta, Georgia, 30303

    LaTrisha Horne, 404-789-3825, lhorne@msm.edu

    Recruiting
  • Morehouse School of Medicine Lee Street

    Atlanta, Georgia, 30310

    LaTrisha Horne, 404-789-3825, lhorne@msm.edu

    Recruiting
  • Morehouse School of Medicine Princeton Lakes

    Atlanta, Georgia, 30331

    LaTrisha Horne, 404-789-3825, lhorne@msm.edu

    Recruiting
  • Morehouse School of Medicine East Point

    Atlanta, Georgia, 30344

    LaTrisha Horne, 404-789-3825, lhorne@msm.edu

    Recruiting
  • Sutter Valley Hospitals Auburn

    Auburn, California, 95603

    Kristina A Teresinski, 279-800-9026, clinicalresearch@sutterhealth.org

    Tiffany James, 707-554-5062, clinicalresearch@sutterhealth.org

    Recruiting
  • HCA Healthcare Doctors Hospital

    Augusta, Georgia, 30909

    Kellie Graves, 615-507-2247, Kellie.Graves@hcahealthcare.com

    Recruiting
  • Ochsner Health Bocage

    Baton Rouge, Louisiana, 70809

    Ellen Lovell, 504-842-8196, Ellen.Lovell@Ochsner.org

    Recruiting
  • Ochsner Health Grove

    Baton Rouge, Louisiana, 70836

    Ellen Lovell, 504-842-8196, Ellen.Lovell@Ochsner.org

    Recruiting
  • OHSU CEDAR Clinical Trials Beaverton

    Beaverton, Oregon, 97006

    Diana Potts, 503-418-8150, REACH@ohsu.edu

    Recruiting
  • Geisinger Bloomsburg Hospital - Bloomsburg

    Bloomsburg, Pennsylvania, 17815

    Ashley Honushefsky, 570-293-7170, reachstudy@geisinger.edu

    Recruiting
  • HCA Healthcare Brentwood

    Brentwood, Tennessee, 37027

    Kellie Graves, 615-507-2247, Kellie.Graves@hcahealthcare.com

    Recruiting
  • West Virginia University Health System St. Joseph

    Buckhannon, West Virginia, 26201

    Courtney Pilkerton, 304-285-7250, DFMresearch@wvumedicine.org

    Recruiting
  • OHSU CEDAR Clinical Trials BAH

    Coos Bay, Oregon, 97420

    Diana Potts, 503-418-8150, REACH@ohsu.edu

    Recruiting
  • Ochsner Health Covington

    Covington, Louisiana, 70433

    Ellen Lovell, 504-842-8196, Ellen.Lovell@Ochsner.org

    Recruiting
  • Ochsner Health St. Tammany Parish

    Covington, Louisiana, 70433

    Ellen Lovell, 504-842-8196, Ellen.Lovell@Ochsner.org

    Recruiting
  • Ochsner Health STCC

    Covington, Louisiana, 70433

    Ellen Lovell, 504-842-8196, Ellen.Lovell@Ochsner.org

    Recruiting
  • Sutter Valley Hospitals Davis

    Davis, California, 95616

    Kristina A Teresinski, 279-800-9026, clinicalresearch@sutterhealth.org

    Tiffany James, 707-554-5062, clinicalresearch@sutterhealth.org

    Recruiting
  • FCCC - East Norriton

    East Norriton, Pennsylvania, 19401

    Camille Ragin, 267-566-3130, Camlle.ragin@fccc.edu

    Recruiting
  • Sutter Valley Hospitals Elk Grove

    Elk Grove, California, 95758

    Kristina A Teresinski, 279-800-9026, clinicalresearch@sutterhealth.org

    Tiffany James, 707-554-5062, clinicalresearch@sutterhealth.org

    Recruiting
  • Community Health Network North

    Fishers, Indiana, 46038

    Allison Landis, 317-621-7724, Alandis@ecommunity.com

    Recruiting
  • Mercy Health - Fort Smith

    Fort Smith, Arkansas, 72903

    Damon Broyles, MercyResearchREACHStudy@Mercy.net

    Recruiting
  • Long Beach Memorial Orange Coast

    Fountain Valley, California, 92708

    Ana Fuentes, 562-760-6849, Afuentes1@memorialcare.org

    Recruiting
  • FCCC - Buckingham

    Furlong, Pennsylvania, 18925

    Camille Ragin, 267-566-3130, Camlle.ragin@fccc.edu

    Recruiting
  • OHSU CEDAR Clinical Trials Orenco

    Hillsboro, Oregon, 97124

    Diana Potts, 503-418-8150, REACH@ohsu.edu

    Recruiting
  • OHSU CEDAR Clinical Trials Woods

    Hood River, Oregon, 97031

    Laura Ferrara, 541-645-3276, REACH@ohsu.edu

    Recruiting
  • Community Health Network East

    Indianapolis, Indiana, 46219

    Allison Landis, 317-621-7724, Alandis@ecommunity.com

    Recruiting
  • Community Health Network South

    Indianapolis, Indiana, 46237

    Allison Landis, 317-621-7724, Alandis@ecommunity.com

    Recruiting
  • Mercy Health - Joplin

    Joplin, Missouri, 64804

    Damon Broyles, MercyResearchREACHStudy@Mercy.net

    Recruiting
  • Ochsner Health Kenner

    Kenner, Louisiana, 70065

    Ellen Lovell, 504-842-8196, Ellen.Lovell@Ochsner.org

    Recruiting
  • Community Health Network Kokomo

    Kokomo, Indiana, 46902

    Allison Landis, 317-621-7724, Alandis@ecommunity.com

    Recruiting
  • Ochsner Health Lafayette

    Lafayette, Louisiana, 70503

    Ellen Lovell, 504-842-8196, Ellen.Lovell@Ochsner.org

    Recruiting
  • Long Beach Memorial Saddleback

    Laguna Hills, California, 92653

    Ana Fuentes, 562-760-6849, Afuentes1@memorialcare.org

    Recruiting
  • Long Beach Memorial Atlantic

    Long Beach, California, 90806

    Ana Fuentes, 562-760-6849, Afuentes1@memorialcare.org

    Recruiting
  • Ochsner Health Westbank

    Marrero, Louisiana, 70072

    Ellen Lovell, 504-842-8196, Ellen.Lovell@Ochsner.org

    Recruiting
  • Ochsner Health Lafreniere

    Metairie, Louisiana, 70003

    Ellen Lovell, 504-842-8196, Ellen.Lovell@Ochsner.org

    Recruiting
  • Sutter Valley Hospitals Modesto

    Modesto, California, 95355

    Kristina A Teresinski, 279-800-9026, clinicalresearch@sutterhealth.org

    Tiffany James, 707-554-5062, clinicalresearch@sutterhealth.org

    Recruiting
  • West Virginia University Health System Morgantown

    Morgantown, West Virginia, 26501

    Courtney Pilkerton, 304-285-7250, DFMresearch@wvumedicine.org

    Recruiting
  • West Virginia University Health System WV CTSI

    Morgantown, West Virginia, 26506

    Courtney Pilkerton, 304-285-7250, DFMresearch@wvumedicine.org

    Recruiting
  • HCA Healthcare Centennial

    Nashville, Tennessee, 37203

    Kellie Graves, 615-507-2247, Kellie.Graves@hcahealthcare.com

    Recruiting
  • HCA Healthcare Nashville

    Nashville, Tennessee, 37203

    Kellie Graves, 615-507-2247, Kellie.Graves@hcahealthcare.com

    Recruiting
  • Ochsner Health Benson

    New Orleans, Louisiana, 70121

    Ellen Lovell, 504-842-8196, Ellen.Lovell@Ochsner.org

    Recruiting
  • Mercy Health - OKC

    Oklahoma City, Oklahoma, 73120

    Damon Broyles, MercyResearchREACHStudy@Mercy.net

    Recruiting
  • Sutter Valley Hospitals PAMF Sutter

    Palo Alto, California, 94301

    Kristina A Teresinski, 279-800-9026, clinicalresearch@sutterhealth.org

    Tiffany James, 707-554-5062, clinicalresearch@sutterhealth.org

    Recruiting
  • FCCC - Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Camille Ragin, 267-566-3130, Camlle.ragin@fccc.edu

    Recruiting
  • FCCC - Jeanes

    Philadelphia, Pennsylvania, 19111

    Camille Ragin, 267-566-3130, Camlle.ragin@fccc.edu

    Recruiting
  • FCCC - Chestnut Hill

    Philadelphia, Pennsylvania, 19118

    Camille Ragin, 267-566-3130, Camlle.ragin@fccc.edu

    Recruiting
  • FCCC - Northeastern

    Philadelphia, Pennsylvania, 19134

    Camille Ragin, 267-566-3130, Camlle.ragin@fccc.edu

    Recruiting
  • FCCC - Broad Street

    Philadelphia, Pennsylvania, 19140

    Camille Ragin, 267-566-3130, Camlle.ragin@fccc.edu

    Recruiting
  • FCCC - Temple Main

    Philadelphia, Pennsylvania, 19140

    Camille Ragin, 267-566-3130, Camlle.ragin@fccc.edu

    Recruiting
  • OHSU CEDAR Clinical Trials Portland

    Portland, Oregon, 97201

    Diana Potts, 503-418-8150, REACH@ohsu.edu

    Recruiting
  • OHSU CEDAR Clinical Trials Richmond

    Portland, Oregon, 97202

    Diana Potts, 503-418-8150, REACH@ohsu.edu

    Recruiting
  • FCCC - Huntingdon Pike

    Rockledge, Pennsylvania, 19046

    Camille Ragin, 267-566-3130, Camlle.ragin@fccc.edu

    Recruiting
  • Sutter Valley Hospitals Roseville

    Roseville, California, 95661

    Kristina A Teresinski, 279-800-9026, clinicalresearch@sutterhealth.org

    Tiffany James, 707-554-5062, clinicalresearch@sutterhealth.org

    Recruiting
  • Sutter Valley Hospitals Alhambra

    Sacramento, California, 95816

    Kristina A Teresinski, 279-800-9026, clinicalresearch@sutterhealth.org

    Tiffany James, 707-554-5062, clinicalresearch@sutterhealth.org

    Recruiting
  • Sutter Valley Hospitals Capitol Pavilion

    Sacramento, California, 95816

    Kristina A Teresinski, 279-800-9026, clinicalresearch@sutterhealth.org

    Tiffany James, 707-554-5062, clinicalresearch@sutterhealth.org

    Recruiting
  • HCA Healthcare St. Marks

    Salt Lake City, Utah, 84124

    Active, not recruiting
  • University of California San Francisco Health System

    San Francisco, California, 94158

    Corinne Sears, 415-205-0182, REACHMCD@ucsf.edu

    Recruiting
  • Sutter Valley Hospitals Santa Barbara

    Santa Barbara, California, 93105

    Kristina Teresinski, 279-800-9026, clinicalresearch@sutterhealth.org

    Tiffany James, 707-554-5062, clinicalresearch@sutterhealth.org

    Recruiting
  • Sutter Valley Hospitals PAMF Santa Cruz

    Santa Cruz, California, 95065

    Kristina A Teresinski, 279-800-9026, clinicalresearch@sutterhealth.org

    Tiffany James, 707-554-5062, clinicalresearch@sutterhealth.org

    Recruiting
  • Sutter Health Santa Rosa

    Santa Rosa, California, 95403

    Kristina A Teresinski, 279-800-9026, clinicalresearch@sutterhealth.org

    Tiffany James, 707-554-5062, clinicalresearch@sutterhealth.org

    Recruiting
  • West Virginia University Health System Shepherdstown

    Shepherdstown, West Virginia, 25443

    Courtney Pilkerton, 304-285-7250, DFMresearch@wvumedicine.org

    Recruiting
  • Mercy Health - Springfield

    Springfield, Missouri, 65807

    Damon Broyles, MercyResearchREACHStudy@Mercy.net

    Recruiting
  • Mercy Health St. Louis

    St Louis, Missouri, 63141

    Damon Broyles, MercyResearchREACHStudy@Mercy.net

    Recruiting
  • Sutter Valley Hospitals PAMF Sunnyvale

    Sunnyvale, California, 94086

    Kristina A Teresinski, 279-800-9026, clinicalresearch@sutterhealth.org

    Tiffany James, 707-554-5062, clinicalresearch@sutterhealth.org

    Recruiting
  • USF Morsani Center for Advanced Healthcare

    Tampa, Florida, 33612

    Dusan Nikolic, clinicalresearch@usf.edu

    Recruiting
  • OHSU CEDAR Clinical Trials Adventist

    The Dalles, Oregon, 97058

    Laura Ferrara, 541-645-3276, REACHstudy@ohsu.edu

    Recruiting
  • OHSU CEDAR Clinical Trials Dalles

    The Dalles, Oregon, 97058

    Laura Ferrara, 541-645-3276, REACH@ohsu.edu

    Recruiting
  • Sutter Valley Hospitals Fairfield

    Vallejo, California, 94589

    Kristina A Teresinski, 279-800-9026, clinicalresearch@sutterhealth.org

    Tiffany James, 707-554-5062, clinicalresearch@sutterhealth.org

    Recruiting
  • OHSU CEDAR Clinical Trials Ensign

    Warrenton, Oregon, 97146

    Laura Ferrara, 541-645-3276, REACH@ohsu.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Conditions
Cancer
Being tested
Multi-Cancer Early Detection Test (Galleri®)
Keywords
ctDNA, Circulating tumor DNA, Screening, Cancer
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT05673018
Study groupRoleWhat they receive
(Galleri + UC)ExperimentalMedicare beneficiaries who receive the Galleri test plus usual care (Galleri + UC).
Receives: Device: Multi-Cancer Early Detection Test (Galleri®)
(UC) aloneNo interventionPassively-enrolled Contemporaneous Comparator Arm of Medicare beneficiaries who receive usual care (UC) alone.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence rates of stage IV cancers

    Measured: Up to 3 Years

Secondary outcomes (4)
  1. Safety: Number and type of invasive procedures performed to evaluate a cancer signal detected test result

    Measured: Up to 3 Years

  2. Galleri test performance in the Galleri + UC arm

    Measured: Up to 3 Years

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

    Measured: Up to 3 Years

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

    Measured: Up to 3 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2023
  2. Study start12 Jul 2024
  3. Primary completionSep 2030 (estimated)
  4. Study completionSep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
The parallel arm is a passively-enrolled contemporaneous comparator cohort of Medicare beneficiaries who receive usual care without MCED screening.
Masking
None (open label)
Enrolment
50,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05673018
Sponsor's protocol ID
GRAIL-MA-002
Status last verified
Oct 2026
First submitted
7 Dec 2022
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Multi-Cancer Early Detection Test (Galleri®) in people with Cancer, run by GRAIL, Inc. at 72 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact GRAIL Medical Information (833-694-2553, customerservice@grail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rates of stage IV cancers (time frame: Up to 3 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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Galleri® in the Medicare Population. (NCT05673018) | AzTrials