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NCT Number: NCT06523868

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

Recruiting

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Key information

Conditions

Cancer Diagnosis

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Elizabeth O'Donnell, MD

CONTACT

[email protected]

857-215-2361

Elizabeth ODonnell, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GRAIL Galleri

Other

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

Primary outcomes

  1. Positive predictive value at 12 Months

    Time frame: 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.

  2. Negative predictive value at 12 Months

    Time frame: 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.

  3. Specificity Rate at 12 Months

    Time frame: 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.

  4. Yield Rate at 12 Months

    Time frame: 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.

  5. Number of Participants Needed to Screen at 12 months

    Time frame: 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.

Secondary outcomes

  1. Cancer Detection Rate Comparison

    Time frame: Up to 12 months

    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).

  2. Stage of Invasive Cancer Diagnosis Comparison

    Time frame: Up to 12 months

    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).

  3. Change in PROMIS Anxiety Short Form Score

    Time frame: Baseline to 12 months

    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.

  4. Change in PROMIS Global Health Score

    Time frame: Baseline to 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth ODonnell, MD

CONTACT

[email protected]

857-215-2361

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • United States Department of Defense

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 26, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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