Evaluation of Multi-Cancer Early Detection Testing in a High-Risk Military Population: The Sentinel Study

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Cancer Diagnosis

Treatments: Other: GRAIL Galleri

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06523868

24-277

Details and patient eligibility

About

The purpose of this research study is to evaluate the possible benefits of an investigational, but commercially available Galleri multi-cancer early detection (MCED) blood test which is designed to detect many types of cancer early in veterans who have served in the military in active duty.

The name of the screening blood test being studied is:

-GRAIL Galleri MCED test

Full description

This research study aims to assess the performance of the Galleri multi-cancer early detection (MCED) screening test in a military population and to compare the number and types of cancers diagnosed using MCED testing versus standard of care. This research study will give doctors and participants results of Galleri® blood tests which is designed to detect many types of cancer.

The research study procedures including screening for eligibility, blood draws, questionnaires, and clinic visits.

Participation in this research study is expected to last for up to 1 year.

It is expected that about 1,500 people will take part in this research study.

The Department of Defense (DoD) is funding this study.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Active-duty or National Guard/Reserves military service for eight or more years
• Age ≥ 45
• Received care at a VA facility within past 5 years
• Able to sign informed consent
• Willingness to travel to Dana-Farber Cancer Institute in Boston, MA, for diagnostic testing if screening test indicates possible malignancy

Exclusion criteria

• Individuals diagnosed with invasive malignancy within 3 years of enrollment (non- melanoma skin cancer is acceptable)
• Individuals with evidence of symptomatic or active cancer requiring therapeutic intervention at the time of participation (hormone therapy for breast/prostate cancer is acceptable)
• Individuals in the process of being evaluated for a clinical suspicion of cancer

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,500 participants in 1 patient group

Galleri MCED Test

Experimental group

Description:

Enrolled participants will complete: * Baseline visit with blood draw and questionnaires * Return of study test result * Online post-test questionnaire * For a positive result, diagnostic work-up could include clinic visits, biopsy, surgery, imaging assessments such as ultrasound, Computed Tomography (CT) scans, or Magnetic Resonance Imaging (MRI) scans. If no cancer is found upon work up, a repeat MCED test may be ordered at the discretion of the principle investigator for up to 1 year from the initial MCED blood test. * Follow-up for a negative MCED blood test could include a repeat test ordered by the principle investigator for up to 1 year from the initial MCED test or a survey or phone call by study staff approximately 1 year after the initial MCED blood test. * Online post-diagnostic questionnaire.

Treatment:

Other: GRAIL Galleri