The DISCOVER Study (DISCOVERY)

Dana-Farber Cancer Institute

Status: Begins enrollment in 4 months

Conditions: Cancer Diagnosis; Cancer

Treatments: Device: GRAIL Galleri MCED test

Study type: Interventional

Funder types: Other

Identifiers

NCT07390643

25-467

Details and patient eligibility

About

The purpose of this research study is to evaluate the possible benefits of screening with an investigational, but commercially available blood test designed to detect many types of cancer.

The name of the screening blood test being studied is:

-GRAIL Galleri MCED test

Full description

The purpose of this pilot research study is to evaluate the possible benefits of screening with an investigational, but commercially available blood test designed to detect many types of cancer. "Investigational" means that this test is being studied and is not approved or cleared by the Food and Drug Administration (FDA).

The multi-cancer early detection test looks for small pieces of genetic material, called DNA (deoxyribonucleic acid), in the blood that may indicate the presence of cancer, and the test may also be able to suggest what type of cancer is present.

The research study procedures include screening for eligibility, in-clinic visit, blood tests, and questionnaires.

It is expected that about 110 people will take part in this research study.

Enrollment: 100 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Be at least 22 years old
• Have signs and symptoms suggestive of cancer and/or have imaging related to signs and symptoms of cancer being evaluated in the Cancer Diagnostic Service clinic

Exclusion criteria

• Individuals diagnosed with invasive malignancy within 3 years of enrollment
• Individuals with 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)

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Galleri MCED Test

Experimental group

Description:

Enrolled participants will complete: * Baseline visit with blood draw and questionnaires * Return of test results: * 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 standard, diagnostic work-up is positive or negative for cancer, follow up will be at the discretion of the principal investigator. * For a negative MCED blood test with standard, diagnostic work-up that is negative, follow-up will be at the discretion of the principal investigator. * Online post-test questionnaire * Online post-diagnostic questionnaire * Follow up will be up to 24 months

Treatment:

Device: GRAIL Galleri MCED test