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Recruiting Not applicable

Galleri® in the Medicare Population.

NCT05673018 · tracked via the Priya Life Science USA tracker
Sponsor
Phase
Not applicable
Started
2024-07-12
Last updated
2026-10-19

Condition(s) studied

Cancer

Investigational drug(s) / intervention(s)

Multi-Cancer Early Detection Test (Galleri®)

Multi-Cancer Early Detection Test (Galleri®): Blood collection and multi-cancer early detection testing with return of results.

Study 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

Sex
ALL
Min age
50 Years
Max age
—
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.

Primary outcome measure(s)

  • Incidence rates of stage IV cancers — Up to 3 Years

Trial sites (72)

FacilityCityRegionStatus
Mercy Health - Fort Smith Fort Smith Arkansas Recruiting
Sutter Valley Hospitals Auburn Auburn California Recruiting
Sutter Valley Hospitals Davis Davis California Recruiting
Sutter Valley Hospitals Elk Grove Elk Grove California Recruiting
Long Beach Memorial Orange Coast Fountain Valley California Recruiting
Long Beach Memorial Saddleback Laguna Hills California Recruiting
Long Beach Memorial Atlantic Long Beach California Recruiting
Sutter Valley Hospitals Modesto Modesto California Recruiting
Sutter Valley Hospitals PAMF Sutter Palo Alto California Recruiting
Sutter Valley Hospitals Roseville Roseville California Recruiting
Sutter Valley Hospitals Alhambra Sacramento California Recruiting
Sutter Valley Hospitals Capitol Pavilion Sacramento California Recruiting
University of California San Francisco Health System San Francisco California Recruiting
Sutter Valley Hospitals Santa Barbara Santa Barbara California Recruiting
Sutter Valley Hospitals PAMF Santa Cruz Santa Cruz California Recruiting
Sutter Health Santa Rosa Santa Rosa California Recruiting
Sutter Valley Hospitals PAMF Sunnyvale Sunnyvale California Recruiting
Sutter Valley Hospitals Fairfield Vallejo California Recruiting
USF Morsani Center for Advanced Healthcare Tampa Florida Recruiting
Morehouse School of Medicine Atlanta Atlanta Georgia Recruiting
Morehouse School of Medicine Lee Street Atlanta Georgia Recruiting
Morehouse School of Medicine Princeton Lakes Atlanta Georgia Recruiting
Morehouse School of Medicine East Point Atlanta Georgia Recruiting
HCA Healthcare Doctors Hospital Augusta Georgia Recruiting
Community Health Network Anderson Anderson Indiana Recruiting
Community Health Network North Fishers Indiana Recruiting
Community Health Network East Indianapolis Indiana Recruiting
Community Health Network South Indianapolis Indiana Recruiting
Community Health Network Kokomo Kokomo Indiana Recruiting
Ochsner Health Bocage Baton Rouge Louisiana Recruiting
Ochsner Health Grove Baton Rouge Louisiana Recruiting
Ochsner Health Covington Covington Louisiana Recruiting
Ochsner Health St. Tammany Parish Covington Louisiana Recruiting
Ochsner Health STCC Covington Louisiana Recruiting
Ochsner Health Kenner Kenner Louisiana Recruiting
Ochsner Health Lafayette Lafayette Louisiana Recruiting
Ochsner Health Westbank Marrero Louisiana Recruiting
Ochsner Health Lafreniere Metairie Louisiana Recruiting
Ochsner Health Benson New Orleans Louisiana Recruiting
Mercy Health - Joplin Joplin Missouri Recruiting

+ 32 more sites — see the full list on the official registry below.

More GRAIL, Inc. trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05673018 on ClinicalTrials.gov ↗ ← All trials in the USA