RecruitingInterventional

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

NCT ID: NCT06523868Sponsor: Dana-Farber Cancer InstituteLast updated: 2026-02-27

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.

Arms & interventions

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

Outcome measures

Primary

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 12 months

Secondary

Cancer Detection Rate Comparison
Time frame: Up to 12 months
Stage of Invasive Cancer Diagnosis Comparison
Time frame: Up to 12 months
Change in PROMIS Anxiety Short Form Score
Time frame: Baseline to 12 months
Change in PROMIS Global Health Score
Time frame: Baseline to 12 months

Eligibility criteria

Sex: AllAge: 45 Years and olderHealthy volunteers: Yes

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 locations (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting

Elizabeth O'Donnell, MD · Contact

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

Elizabeth ODonnell, MD · Principal Investigator