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RECRUITING

NCT05673018

Galleri® in the Medicare Population.

Sponsor: GRAIL, Inc.

View on ClinicalTrials.gov

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.

Official title: REACH Study: Galleri® in the Medicare Population.

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50000

Start Date

2024-07-12

Completion Date

2030-09

Last Updated

2026-05-22

Healthy Volunteers

Yes

Conditions

Cancer

Interventions

DEVICE

Multi-Cancer Early Detection Test (Galleri®)

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

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.

Locations (61)

Mercy Health - Fort Smith

Fort Smith, Arkansas, United States

Sutter Valley Hospitals Auburn

Auburn, California, United States

Sutter Valley Hospitals Davis

Davis, California, United States

Sutter Valley Hospitals Elk Grove

Elk Grove, California, United States

Long Beach Memorial Orange Coast

Fountain Valley, California, United States

Long Beach Memorial Saddleback

Laguna Hills, California, United States

Long Beach Memorial Atlantic

Long Beach, California, United States

Sutter Valley Hospitals Modesto

Modesto, California, United States

Sutter Valley Hospitals PAMF Sutter

Palo Alto, California, United States

Sutter Valley Hospitals Roseville

Roseville, California, United States

Sutter Valley Hospitals Alhambra

Sacramento, California, United States

Sutter Valley Hospitals Capitol Pavilion

Sacramento, California, United States

University of California San Francisco Health System

San Francisco, California, United States

Sutter Valley Hospitals Santa Barbara

Santa Barbara, California, United States

Sutter Valley Hospitals PAMF Santa Cruz

Santa Cruz, California, United States

Sutter Health Santa Rosa

Santa Rosa, California, United States

Sutter Valley Hospitals PAMF Sunnyvale

Sunnyvale, California, United States

Sutter Valley Hospitals Fairfield

Vallejo, California, United States

USF Morsani Center for Advanced Healthcare

Tampa, Florida, United States

Morehouse School of Medicine Atlanta

Atlanta, Georgia, United States

Morehouse School of Medicine Lee Street

Atlanta, Georgia, United States

Morehouse School of Medicine Princeton Lakes

Atlanta, Georgia, United States

Morehouse School of Medicine East Point

Atlanta, Georgia, United States

HCA Healthcare Doctors Hospital

Augusta, Georgia, United States

Community Health Network Anderson

Anderson, Indiana, United States

Community Health Network North

Fishers, Indiana, United States

Community Health Network East

Indianapolis, Indiana, United States

Community Health Network South

Indianapolis, Indiana, United States

Community Health Network Kokomo

Kokomo, Indiana, United States

Community Health Network LaFountain

Kokomo, Indiana, United States

Ochsner Health Bocage

Baton Rouge, Louisiana, United States

Ochsner Health Grove

Baton Rouge, Louisiana, United States

Ochsner Health Covington

Covington, Louisiana, United States

Ochsner Health St. Tammany Parish

Covington, Louisiana, United States

Ochsner Health STCC

Covington, Louisiana, United States

Ochsner Health Kenner

Kenner, Louisiana, United States

Ochsner Health Lafayette

Lafayette, Louisiana, United States

Ochsner Health Westbank

Marrero, Louisiana, United States

Ochsner Health Lafreniere

Metairie, Louisiana, United States

Ochsner Health Baptist

New Orleans, Louisiana, United States

Ochsner Health Benson

New Orleans, Louisiana, United States

Mercy Health - Springfield

Springfield, Missouri, United States

Mercy Health St. Louis

St Louis, Missouri, United States

OHSU CEDAR Clinical Trials Columbia

Astoria, Oregon, United States

OHSU CEDAR Clinical Trials Exchange

Astoria, Oregon, United States

OHSU CEDAR Clinical Trials Beaverton

Beaverton, Oregon, United States

OHSU CEDAR Clinical Trials Orenco

Hillsboro, Oregon, United States

OHSU CEDAR Clinical Trials Woods

Hood River, Oregon, United States

OHSU CEDAR Clinical Trials Portland

Portland, Oregon, United States

OHSU CEDAR Clinical Trials Richmond

Portland, Oregon, United States

OHSU CEDAR Clinical Trials Adventist

The Dalles, Oregon, United States

OHSU CEDAR Clinical Trials Dalles

The Dalles, Oregon, United States

OHSU CEDAR Clinical Trials Ensign

Warrenton, Oregon, United States

Geisinger Bloomsburg Hospital - Bloomsburg

Bloomsburg, Pennsylvania, United States

HCA Healthcare Brentwood

Brentwood, Tennessee, United States

HCA Healthcare Centennial

Nashville, Tennessee, United States

HCA Healthcare Nashville

Nashville, Tennessee, United States

HCA Healthcare St. Marks

Salt Lake City, Utah, United States

West Virginia University Health System St. Joseph

Buckhannon, West Virginia, United States

West Virginia University Health System Morgantown

Morgantown, West Virginia, United States

West Virginia University Health System WV CTSI

Morgantown, West Virginia, United States

Clinical Research Directory

Galleri® in the Medicare Population.

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (61)