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NCT05673018NARecruitingAccepts Healthy Volunteers

Galleri® in the Medicare Population.

GRAIL, Inc.

Start Date

7/12/2024

Completion Date

9/1/2030

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.

Eligibility Criteria

Age Range: 50 years to No maximum

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.

Interventions

DEVICE

Multi-Cancer Early Detection Test (Galleri®)

Interested in This Trial?

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Conditions

Cancer

Locations

Mercy Health - Fort Smith

Fort Smith, Arkansas 72903

United States

Sutter Valley Hospitals Auburn

Auburn, California 95603

United States

Sutter Valley Hospitals Davis

Davis, California 95616

United States

Sutter Valley Hospitals Elk Grove

Elk Grove, California 95758

United States

Long Beach Memorial Orange Coast

Fountain Valley, California 92708

United States

Long Beach Memorial Saddleback

Laguna Hills, California 92653

United States

Long Beach Memorial Atlantic

Long Beach, California 90806

United States

Sutter Valley Hospitals Modesto

Modesto, California 95355

United States

Sutter Valley Hospitals PAMF Sutter

Palo Alto, California 94301

United States

Sutter Valley Hospitals Roseville

Roseville, California 95661

United States

Sutter Valley Hospitals Alhambra

Sacramento, California 95816

United States

Sutter Valley Hospitals Capitol Pavilion

Sacramento, California 95816

United States

University of California San Francisco Health System

San Francisco, California 94158

United States

Sutter Valley Hospitals Santa Barbara

Santa Barbara, California 93105

United States

Sutter Valley Hospitals PAMF Santa Cruz

Santa Cruz, California 95065

United States

Sutter Health Santa Rosa

Santa Rosa, California 95403

United States

Sutter Valley Hospitals PAMF Sunnyvale

Sunnyvale, California 94086

United States

Sutter Valley Hospitals Fairfield

Vallejo, California 94589

United States

USF Morsani Center for Advanced Healthcare

Tampa, Florida 33612

United States

Morehouse School of Medicine Atlanta

Atlanta, Georgia 30303

United States

Morehouse School of Medicine Lee Street

Atlanta, Georgia 30310

United States

Morehouse School of Medicine Princeton Lakes

Atlanta, Georgia 30331

United States

Morehouse School of Medicine East Point

Atlanta, Georgia 30344

United States

HCA Healthcare Doctors Hospital

Augusta, Georgia 30909

United States

Community Health Network Anderson

Anderson, Indiana 46011

United States

Community Health Network North

Fishers, Indiana 46038

United States

Community Health Network East

Indianapolis, Indiana 46219

United States

Community Health Network South

Indianapolis, Indiana 46256

United States

Community Health Network Kokomo

Kokomo, Indiana 46902

United States

Community Health Network LaFountain

Kokomo, Indiana 46902

United States

Ochsner Health Bocage

Baton Rouge, Louisiana 70809

United States

Ochsner Health Grove

Baton Rouge, Louisiana 70836

United States

Ochsner Health Covington

Covington, Louisiana 70433

United States

Ochsner Health St. Tammany Parish

Covington, Louisiana 70433

United States

Ochsner Health STCC

Covington, Louisiana 70433

United States

Ochsner Health Kenner

Kenner, Louisiana 70065

United States

Ochsner Health Lafayette

Lafayette, Louisiana 70503

United States

Ochsner Health Westbank

Marrero, Louisiana 70072

United States

Ochsner Health Lafreniere

Metairie, Louisiana 70003

United States

Ochsner Health Baptist

New Orleans, Louisiana 70115

United States

Ochsner Health Benson

New Orleans, Louisiana 70121

United States

Mercy Health - Springfield

Springfield, Missouri 65807

United States

Mercy Health St. Louis

St Louis, Missouri 63141

United States

OHSU CEDAR Clinical Trials Columbia

Astoria, Oregon 97103

United States

OHSU CEDAR Clinical Trials Exchange

Astoria, Oregon 97103

United States

OHSU CEDAR Clinical Trials Beaverton

Beaverton, Oregon 97006

United States

OHSU CEDAR Clinical Trials Orenco

Hillsboro, Oregon 97124

United States

OHSU CEDAR Clinical Trials Woods

Hood River, Oregon 97031

United States

OHSU CEDAR Clinical Trials Portland

Portland, Oregon 97201

United States

OHSU CEDAR Clinical Trials Richmond

Portland, Oregon 97202

United States

OHSU CEDAR Clinical Trials Adventist

The Dalles, Oregon 97058

United States

OHSU CEDAR Clinical Trials Dalles

The Dalles, Oregon 97058

United States

OHSU CEDAR Clinical Trials Ensign

Warrenton, Oregon 97146

United States

Geisinger Bloomsburg Hospital - Bloomsburg

Bloomsburg, Pennsylvania 17815

United States

HCA Healthcare Brentwood

Brentwood, Tennessee 37027

United States

HCA Healthcare Centennial

Nashville, Tennessee 37203

United States

HCA Healthcare Nashville

Nashville, Tennessee 37203

United States

HCA Healthcare St. Marks

Salt Lake City, Utah 84124

United States

West Virginia University Health System St. Joseph

Buckhannon, West Virginia 26201

United States

West Virginia University Health System Morgantown

Morgantown, West Virginia 26501

United States

West Virginia University Health System WV CTSI

Morgantown, West Virginia 26506

United States