Galleri in the Medicare Population

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).


Eligibility Criteria:
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.