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

NCT06523868 | Recruiting

• 1 other identifier: 24-277
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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

Conditions

Cancer Diagnosis

Keywords

Cancer Diagnosis

Outcome Measures

Primary Outcomes (5)

• Positive predictive value at 12 Months

  Positive predictive value is defined as the proportion of participants with cancer diagnosis out of all participants with "signal detected" on GRAIL Galleri MCED test results.

  At 12 months

• Negative predictive value at 12 Months

  Negative predictive value is defined as the proportion of participants with no cancer diagnosis out of all participants with "signal not detected" on GRAIL Galleri MCED test results.

  At 12 months

• Specificity Rate at 12 Months

  Specificity is defined as the proportion of participants with "signal not detected" results out of all participants with no cancer diagnosis on GRAIL Galleri MCED test results.

  At 12 months

• Yield Rate at 12 Months

  Yield rate is defined as the proportion of participants with "signal detected" out of all participants tested on GRAIL Galleri MCED test.

  At 12 months

• Number of Participants Needed to Screen at 12 months

  Number Needed to Screen (NNS) is defined as the number of participants screened to detect a diagnosis of invasive cancer on the GRAIL Galleri MCED test.

  At 12 months

Secondary Outcomes (4)

• Cancer Detection Rate Comparison

  Up to 12 months

• Stage of Invasive Cancer Diagnosis Comparison

  Up to 12 months

• Change in PROMIS Anxiety Short Form Score

  Baseline to 12 months

• Change in PROMIS Global Health Score

  Baseline to 12 months

Study Arms (1)

Galleri MCED Test

EXPERIMENTAL

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.

Other: GRAIL Galleri

Interventions

GRAIL Galleri OTHER

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

Galleri MCED Test

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active-duty or National Guard/Reserves military service for four 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• United States Department of Defense: collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Study Officials

• Elizabeth ODonnell, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth ODonnell, MD

CONTACT

857-215-2361; elizabeth_odonnell@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 26, 2024
• Study Start: March 31, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)