Galleri® in the Medicare Population.

Recruiting now · Not applicable

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT05673018

Run by

GRAIL, Inc.

People needed

50000

Starts

2024-07-12

Expected to finish

2030-09-01

Last updated by the study team

2026-05-22

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).
• 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.

Where it is running

• Sutter Valley Hospitals Auburn — Auburn, California, United States (enrolling)
• Sutter Valley Hospitals Davis — Davis, California, United States (enrolling)
• Sutter Valley Hospitals Elk Grove — Elk Grove, California, United States (enrolling)
• Long Beach Memorial Orange Coast — Fountain Valley, California, United States (enrolling)
• Long Beach Memorial Saddleback — Laguna Hills, California, United States (enrolling)
• Long Beach Memorial Atlantic — Long Beach, California, United States (enrolling)
• Sutter Valley Hospitals Modesto — Modesto, California, United States (enrolling)
• Sutter Valley Hospitals PAMF Sutter — Palo Alto, California, United States (enrolling)
• Sutter Valley Hospitals Roseville — Roseville, California, United States (enrolling)
• Sutter Valley Hospitals Alhambra — Sacramento, California, United States (enrolling)
• Sutter Valley Hospitals Capitol Pavilion — Sacramento, California, United States (enrolling)
• University of California San Francisco Health System — San Francisco, California, United States (enrolling)
• Sutter Valley Hospitals Santa Barbara — Santa Barbara, California, United States (enrolling)
• Sutter Valley Hospitals PAMF Santa Cruz — Santa Cruz, California, United States (enrolling)
• Sutter Health Santa Rosa — Santa Rosa, California, United States (enrolling)
• Sutter Valley Hospitals PAMF Sunnyvale — Sunnyvale, California, United States (enrolling)
• Sutter Valley Hospitals Fairfield — Vallejo, California, United States (enrolling)
• USF Morsani Center for Advanced Healthcare — Tampa, Florida, United States (enrolling)
• Morehouse School of Medicine Atlanta — Atlanta, Georgia, United States (enrolling)
• Morehouse School of Medicine Lee Street — Atlanta, Georgia, United States (enrolling)
• Morehouse School of Medicine Princeton Lakes — Atlanta, Georgia, United States (enrolling)
• Morehouse School of Medicine East Point — Atlanta, Georgia, United States (enrolling)
• HCA Healthcare Doctors Hospital — Augusta, Georgia, United States (enrolling)
• Community Health Network Anderson — Anderson, Indiana, United States (enrolling)
• Mercy Health - Fort Smith — Fort Smith, Arkansas, United States (enrolling)

Full record on ClinicalTrials.gov

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