MedPath

Galleri in the Medicare Population

Not Applicable
Recruiting
Conditions
Cancer
Interventions
Device: Multi-Cancer Early Detection Test (Galleri®)
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

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,
  • Eligible to receive the Galleri test, based on a determination by the study investigator or designee that the test is clinically appropriate,
  • Capable of giving informed consent that is legally effective (consent provided by a legally authorized representative is not permitted in this protocol), and
  • Able to comprehend and respond to questions in participant questionnaires. Comprehension level is determined by the study investigator or designee.

For UC (Not Galleri-tested Arm):

  • Aged ≥ 50 years with Medicare coverage,
  • Have had ≥ 1 UC visit
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Exclusion Criteria

For Galleri + UC (Galleri-Tested Arm):

  • Having had a previous Galleri test not associated with this study.
  • Undergoing clinical evaluation for symptoms suspicious for cancer.
  • Personal history of invasive solid tumor or hematologic malignancy, diagnosed within the 3 years prior to expected enrollment date, or diagnosed greater than 3 years prior to expected enrollment date and never treated.
  • Individuals with a diagnosis of non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin are not excluded.
  • Prior/Concurrent Concomitant Therapy (Medications/Treatments):
  • Definitive treatment for invasive solid tumor or hematologic malignancy within the 3 years prior to expected enrollment date.
  • Adjuvant hormone therapy for cancer (i.e., for breast or prostate cancer) is not an exclusion criterion.
  • Current pregnancy
  • Individuals who will not be 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):

  • Undergoing or referred for diagnostic evaluation due to clinical suspicion for cancer (e.g., referred to a medical or surgical oncologist, or scheduled for biopsy on the basis of a suspicious imaging abnormality).
  • Personal history of invasive solid tumor or hematologic malignancy, diagnosed within the 3 years prior to expected enrollment date, or diagnosed greater than 3 years prior to expected enrollment date and never treated.
  • Individuals with a diagnosis of non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin are not excluded.
  • Prior/Concurrent Concomitant Therapy (Medications/Treatments):
  • Definitive treatment for invasive solid tumor or hematologic malignancy within the 3 years prior to expected enrollment date.
  • Adjuvant hormone therapy for cancer (e.g. for breast or prostate cancer) is not an exclusion criterion.
  • Current pregnancy.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
(Galleri + UC)Multi-Cancer Early Detection Test (Galleri®)Medicare beneficiaries who receive the Galleri test plus usual care (Galleri + UC).
Primary Outcome Measures
NameTimeMethod
Incidence rates of stage IV cancersUp to 3 Years
Secondary Outcome Measures
NameTimeMethod
Safety: Number and type of invasive procedures performed to evaluate a cancer signal detected test resultUp to 3 Years
Adherence to guideline-recommended cancer screening in the Galleri+UC arm and UC arm over timeUp to 3 Years
Healthcare resource utilization associated with cancer diagnostic evaluations in the Galleri+UC arm and UC armUp to 3 Years
Galleri test performance in the Galleri + UC armUp to 3 Years

Trial Locations

Locations (1)

Community Health Network

🇺🇸

Indianapolis, Indiana, United States

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