Recruiting

Multi-Cancer Detection

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT06523868

Conditions

Cancer Diagnosis

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Accepted

Interventions

GRAIL Galleri

Study Details

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

Study ID

NCT06523868

Start date

Mar 31, 2025

Status verified date

Feb, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Accepted

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 Design

Enrollment

1500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

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.

Interventions

GRAIL Galleri

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

Primary outcome measure

  • Positive predictive value at 12 Months [ Time Frame: At 12 months ]
  • Negative predictive value at 12 Months [ Time Frame: At 12 months ]
  • Specificity Rate at 12 Months [ Time Frame: At 12 months ]
  • Yield Rate at 12 Months [ Time Frame: At 12 months ]
  • Number of Participants Needed to Screen at 12 months [ Time Frame: At 12 months ]

Central Contacts and Locations

Central contacts

Elizabeth ODonnell, MD

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

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Elizabeth O'Donnell, MD

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

Principal Investigator:

Elizabeth ODonnell, MD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • Cancer Diagnosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-02-27.