Galleri in the Medicare Population
- 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
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description (Galleri + UC) Multi-Cancer Early Detection Test (Galleri®) Medicare beneficiaries who receive the Galleri test plus usual care (Galleri + UC).
- 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 (1)
Community Health Network
🇺🇸Indianapolis, Indiana, United States