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

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

Study Overview

• Status: Recruiting
• Conditions: Cancer Diagnosis
• Intervention / Treatment: Other: GRAIL Galleri

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.

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth ODonnell, MD; Phone Number: 857-215-2361; Email: elizabeth_odonnell@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Principal Investigator: Elizabeth ODonnell, MD
      • Contact: Elizabeth O'Donnell, MD; Phone Number: 857-215-2361; Email: elizabeth_odonnell@dfci.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Other: GRAIL Galleri; A multi-cancer early detection (MCED) blood test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer Detection Rate Comparison	Descriptive statistics will be used to summarize the number and types of cancers diagnosed by GRAIL Galleri MCED testing compared to Standard of Care (SOC) in matched population from the VA (separate IRB protocol).	Up to 12 months
Stage of Invasive Cancer Diagnosis Comparison	Descriptive statistics will be used to summarize the stages of invasive cancer that are diagnosed by GRAIL Galleri MCED testing assessed by medical record review compared to Standard of Care (SOC) in matched population from the VA (separate IRB protocol).	Up to 12 months
Change in PROMIS Anxiety Short Form Score	Changes in anxiety following the GRAIL Galleri MCED test result and assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Emotional Distress Anxiety - Short Form 6a, which is a 6 item survey that is rated on a 5-point Likert scale with answers ranging from "Never" to "Always". The range of scoring is from 6 to 30 with higher scores indicating greater severity of anxiety.	Baseline to 12 months
Change in PROMIS Global Health Score	Changes in health-related quality of life following the GRAIL Galleri MCED test result and assessed by PROMIS Scale v1.2 - Global Health, a 10 item survey that is rated on a 5-point Likert scale with answers ranging from "Excellent/Completely/Never/None" to "Poor/Not at all/Always/Very Severe" and includes a pain average question rated on a scale of 0 "No Pain" to 10 "Worst Pain Imaginable." The range of scoring is from 9 to 45 with higher scores indicating higher quality of life.	Baseline to 12 months

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Elizabeth ODonnell, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Cancer Diagnosis
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: 24-277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No