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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT06523868
Status
Recruiting
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Conditions

  • Cancer Diagnosis

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • GRAIL Galleri — OTHER
    A multi-cancer early detection (MCED) blood test.

Study Details

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

Key Dates

Start date
Mar 31, 2025
Status verified
Feb 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
1,500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: 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.

Primary Outcome Measure

Positive predictive value at 12 Months [ Time Frame: At 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Elizabeth O'Donnell, MD
[email protected]
857-215-2361
Elizabeth ODonnell, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Dana-Farber Cancer Institute· Boston, MA

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