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Galleri® in the Medicare Population.
RecruitingHealthy volunteers welcome
REACH Study: Galleri® in the Medicare Population.
Who can join
Ages 50 and older · All sexes · Healthy volunteers welcome
Full eligibility criteria
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.
About the study
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.
What is being tested
- Multi-Cancer Early Detection Test (Galleri®) (device)
Sponsor: GRAIL, Inc. · Participants: 50,000 · Started: Jul 12, 2024
Contact the study team
- GRAIL Medical Information · Phone: 833-694-2553
Official record on ClinicalTrials.gov — NCT05673018
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.