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

NCT ID: NCT06523868

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2028-09-30

Brief Summary

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

Detailed 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.

Conditions

Cancer Diagnosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Galleri MCED Test

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.

Group Type: EXPERIMENTAL

GRAIL Galleri

Intervention Type: OTHER

A multi-cancer early detection (MCED) blood test.

Interventions

GRAIL Galleri

A multi-cancer early detection (MCED) blood test.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth ODonnell

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth ODonnell, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elizabeth ODonnell, MD

Role: CONTACT

elizabeth_odonnell@dfci.harvard.edu

857-215-2361

Facility Contacts

Elizabeth O'Donnell, MD

Role: primary

elizabeth_odonnell@dfci.harvard.edu

857-215-2361

Other Identifiers

24-277

Identifier Type: -

Identifier Source: org_study_id