Galleri® in the Medicare Population.

Official title

REACH Study: Galleri® in the Medicare Population.

Overview

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 enrollment that is representative of the Medicare population.

Interventions

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

Primary outcome measures

• Incidence rates of stage IV cancers [Time frame: Up to 3 Years]

Secondary outcome measures (4)

• Safety: Number and type of invasive procedures performed to evaluate a cancer signal detected test result [Time frame: Up to 3 Years]
• Galleri test performance in the Galleri + UC arm [Time frame: Up to 3 Years]
• Adherence to guideline-recommended cancer screening in the Galleri+UC arm and UC arm over time [Time frame: Up to 3 Years]
• Healthcare resource utilization associated with cancer diagnostic evaluations in the Galleri+UC arm and UC arm [Time frame: Up to 3 Years]

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, including Traditional Medicare (Part A \& B or Dual Eligibles) or Medicare Advantage.
• Capable of giving informed consent that is legally effective (consent provided by a legally authorized representative is not permitted in this protocol).

For UC (Not 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, including Traditional Medicare (Part A \& B or Dual Eligibles) or Medicare Advantage.
• Have had ≥ 1 UC visit

Exclusion criteria

For Galleri + UC (Galleri-Tested Arm):

• Evidence of having had a previous MCED test (including but not limited to the Galleri test, e.g. CancerSeek, PanSeer). Participation in a study such as GRAIL's STRIVE study where results were not returned is not an exclusion criterion.
• Undergoing clinical evaluation for suspicion of cancer within 6 months prior to enrollment. Personal history of hematologic malignancy and/or invasive solid tumor (excluding non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin):

• Diagnosed ≤3 years before expected enrollment date and/or
• Diagnosed >3 years before expected enrollment date and never treated and/or
• Currently undergoing active cancer management (not including adjuvant hormone therapy for breast or prostate cancer).
• Current pregnancy.
• Individuals who are currently inpatients at a participating site.
• Individuals who are not willing or 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):

• Evidence of having had a previous MCED test (including but not limited to the Galleri test, eg.CancerSeek, PanSeer). Participation in a study such as GRAIL's STRIVE study where results were not returned is not an exclusion criterion.
• Undergoing clinical evaluation for suspicion of cancer.
• Personal history of hematologic malignancy and/or invasive solid tumor (not including non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin):

• Diagnosed ≤3 years before expected enrollment date and/or
• Diagnosed >3 years before expected enrollment date and never treated and/or
• Currently undergoing active cancer management (not including adjuvant hormone therapy for breast or prostate cancer).
• Current pregnancy.
• Individuals who are currently inpatients at a participating site.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Screening

Study locations

United States · 61 centers

• Mercy Health - Fort Smith — Fort Smith
• Sutter Valley Hospitals Auburn — Auburn
• Sutter Valley Hospitals Davis — Davis
• Sutter Valley Hospitals Elk Grove — Elk Grove
• Long Beach Memorial Orange Coast — Fountain Valley
• Long Beach Memorial Saddleback — Laguna Hills
• Long Beach Memorial Atlantic — Long Beach
• Sutter Valley Hospitals Modesto — Modesto
• … and 53 more centers

Identifiers

NCT: NCT05673018 · GRAIL-MA-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗