Galleri® in the Medicare Population.

Not Applicable

Recruiting

• Conditions: Cancer

• Registration Number: NCT05673018
• Lead Sponsor: GRAIL, Inc.

Brief 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 to enroll approximately 20% of the study participants from under-represented minority populations (e.g., racial / ethnic minority groups, socioeconomically disadvantaged populations, rural populations).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2023-01-04
• Study First Posted: 2023-01-05
• Study Start: 2024-07-12
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-05
• Last Update Posted: 2025-09-09
• Primary Completion: 2030-09
• Study Completion: 2030-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence rates of stage IV cancers	Up to 3 Years

Secondary Outcome Measures

Name	Time	Method
Safety: Number and type of invasive procedures performed to evaluate a cancer signal detected test result	Up to 3 Years
Adherence to guideline-recommended cancer screening in the Galleri+UC arm and UC arm over time	Up to 3 Years
Healthcare resource utilization associated with cancer diagnostic evaluations in the Galleri+UC arm and UC arm	Up to 3 Years
Galleri test performance in the Galleri + UC arm	Up to 3 Years

Trial Locations

Locations (43)

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

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; 🇺🇸 Long Beach, California, United States

Sutter Valley Hospitals Modesto; 🇺🇸 Modesto, California, United States

Sutter Valley Hospitals PAMF Sutter; 🇺🇸 Palo Alto, California, United States

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