Galleri in the Medicare Population

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 50000

Inclusion 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.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence rates of stage IV cancers

Secondary Outcome Measures

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

Related Trials