Galleri in the Medicare Population

Cancer Clinical Trial

Official title:

REACH Study: Real-world Evidence to Advance Multi-Cancer Early Detection Health Equity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05673018
• Other study ID #: GRAIL-MA-002
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: September 2030

Study information

• Verified date: May 2024
• Source: GRAIL, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 20% of the study participants from under-represented minority populations (e.g., racial / ethnic minority groups, socioeconomically disadvantaged populations, rural populations).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50000
• Est. completion date: September 2030
• Est. primary completion date: September 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Diagnostic Test:
• Multi-Cancer Early Detection Test (Galleri®)
Blood collection and multi-cancer early detection testing with return of results.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GRAIL, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rates of stage IV cancers		Up to 3 Years
Secondary	Safety: Number and type of invasive procedures performed to evaluate a cancer signal detected test result		Up to 3 Years
Secondary	Galleri test performance in the Galleri + UC arm		Up to 3 Years
Secondary	Adherence to guideline-recommended cancer screening in the Galleri+UC arm and UC arm over time		Up to 3 Years
Secondary	Healthcare resource utilization associated with cancer diagnostic evaluations in the Galleri+UC arm and UC arm		Up to 3 Years