Galleri in the Medicare Population

GRAIL, Inc.

Status

Enrolling

Conditions

Cancer

Treatments

Device: Multi-Cancer Early Detection Test (Galleri®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05673018

GRAIL-MA-002

Details and patient eligibility

About

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).

Enrollment

50,000 estimated patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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

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.