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 enrollment that is representative of the Medicare population.

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, 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):

  1. Diagnosed ≤3 years before expected enrollment date and/or
  2. Diagnosed >3 years before expected enrollment date and never treated and/or
  3. 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):

  1. Diagnosed ≤3 years before expected enrollment date and/or
  2. Diagnosed >3 years before expected enrollment date and never treated and/or
  3. 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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50,000 participants in 2 patient groups

(Galleri + UC)

Experimental group

Description:

Medicare beneficiaries who receive the Galleri test plus usual care (Galleri + UC).

Treatment:

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

(UC) alone

No Intervention group

Description:

Passively-enrolled Contemporaneous Comparator Arm of Medicare beneficiaries who receive usual care (UC) alone.