Recruiting

GRAIL Galleri

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT06450171

Conditions

Cancer Predisposition Syndrome

Predisposition, Genetic

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Interventions

GRAIL Galleri Test

Study Details

Brief summary:

The purpose of this research study is to evaluate the possible benefits and harms of screening with an investigational blood test designed to detect many types of cancer early.

The name of the screening blood test being studied is:

-GRAIL Galleri test

Conditions

Cancer Predisposition Syndrome

Predisposition, Genetic

Study ID

NCT06450171

Start date

Sep 27, 2024

Status verified date

Jan, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Inclusion Criteria Group 1- Cancer Predisposition Syndrome:

  • Age ≥ 22 for patients with TP53 germline pathogenic variants, age ≥ 35 for all other variants in cancer predisposing genes
  • Germline genetic testing revealed pathogenic germline variants in cancer predisposing genes (list of genes typically tested listed in pre-screening document)
  • Individuals with a clinically based diagnosis of a Cancer Predisposition Syndrome (examples, neurofibromatosis, Fanconi Anemia, Ataxia-Telangiectasia)

Inclusion Criteria Group 2 - Familial Risk:

  • Age ≥ 45
  • Adults with family history suggestive of elevated cancer risk as defined by any the criteria below, who do not fall into Group 1:

  • ≥ 1 first or second degree relative on same side of the family with:

  • Breast, colon, gastric, endometrial, kidney cancer at or before age 50
  • Triple negative breast cancer (any age)
  • Male breast cancer (any age)
  • Ovarian, pancreatic, sarcoma cancer (any age)
  • Neuroendocrine cancer or tumors (any age)
  • Metastatic prostate cancer (any age)
  • Multiple primary cancers (example bilateral breast cancer)
  • ≥ 2 first or second degree relative on same side of the family (any combination is acceptable) with breast or prostate cancer at any age

Exclusion Criteria:

  • Individuals diagnosed with invasive malignancy within 3 years of enrollment
  • Have had a blood-based multi-cancer screening test within last year
  • Individuals with evidence of symptomatic or active cancer requiring active therapeutic intervention at the time of participation (hormone therapy for breast/prostate cancer is considered acceptable and will not preclude participation)
  • Individuals in Group 2 whose family history of cancer was the result of a germline mutation in a cancer predisposing gene and who have tested negative for that same familial germline mutation
  • Individuals in Group 2 whose family history of cancer is sex-specific and who is a different sex than the proband with cancer (e.g., a male with a family history of endometrial or ovarian cancer would not be eligible)
  • Individuals in process of being evaluated for clinical suspicion of cancer
  • Individuals who have undergone a cancer risk-reducing surgery for hereditary cancer risk (e.g., mastectomy)

Study Design

Enrollment

1000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Galleri MCED Test

Participants will be enrolled and will complete:

  • Baseline questionnaires and blood test.
  • Post-test questionnaires.
  • Follow-up assessments for a negative GRAIL Galleri test include recommended cancer screenings and a follow up phone call with study staff 1 year after the GRAIL Galleri blood test.
  • Follow-up assessments for a positive GRAIL test may include clinic visits, lab tests with additional blood work-ups, biopsies, surgical procedures, or imaging assessments such as ultrasound, Computed Tomography (CT) scans, or an Magnetic Resonance Imaging (MRI) scans.
  • If cancer status is confirmed, participants will complete a post-diagnostic questionnaire.

Interventions

GRAIL Galleri Test

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

Primary outcome measure

  • Cancer Detection Rate [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Elizabeth ODonnell, MD

617-762-2334dfciprevention@mgb.org

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Elizabeth ODonnell, MD

587-215-2361elizabeth_odonnell@dfci.harvard.edu

Principal Investigator:

Elizabeth ODonnell, MD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Keywords

  • Cancer Predisposition Syndrome
  • Predisposition, Genetic

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 2026-01-20.