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NCT Number: NCT07390643

The DISCOVER Study

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

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Key information

Conditions

Cancer Cancer Diagnosis Neoplasms

Age range

22 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 contact

Elizabeth O'Donnell, MD

CONTACT

[email protected]

857-215-2361

Elizabeth ODonnell, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

GRAIL Galleri MCED test

Device

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

Primary outcomes

  1. Multi-cancer Early Detection (MCED) Positive Cancer Type

    Time frame: MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.

    MCED positive cancer type is defined as the type of cancer detected by the MCED test. Cancer type will be defined and recorded using ICD-O-3 codes for primary anatomic site (topography) and histology (morphology).

  2. Multi-cancer Early Detection (MCED) Positive Cancer Incidence

    Time frame: MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.

    MCED positive cancer incidence is defined as the number of cancers detected by the MCED test.

  3. Multi-cancer Early Detection (MCED) Positive Cancer Stage

    Time frame: MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.

    MCED positive cancer stage is defined as the stage of cancer detected by the MCED test.

  4. Multi-cancer Early Detection (MCED) Undetected Cancer Type

    Time frame: MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.

    MCED undetected cancer type is defined as the cancer type detected by standard diagnostic methods that was not identified by the MCED test. Cancer type will be recorded using ICD-O-3 codes for both the primary anatomic site (topography) and histology (morphology).

  5. Multi-cancer Early Detection (MCED) Undetected Cancer Incidence

    Time frame: MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.

    MCED undetected cancer incidence is defined as the number of cancers detected by standard diagnostic methods that was not identified by the MCED test.

  6. Multi-cancer Early Detection (MCED) Undetected Cancer Stage

    Time frame: MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.

    MCED undetected cancer stage is defined as the stage of cancer detected by standard diagnostic methods that was not identified by the MCED test. Hodgkin lymphoma (HL) is typically staged using the Ann Arbor system; non-Hodgkin lymphoma (NHL) is staged according to the Lugano classification; multiple myeloma (MM) is staged using the International Staging System (ISS); and chronic lymphocytic leukemia (CLL) is staged according to the Rai staging system.

Secondary outcomes

  1. Positive Predictive Value (PPV) of Multi-cancer Early Detection (MCED)

    Time frame: 12 months

    PPV of the MCED test will be calculated as the proportion of participants diagnosed with cancer among all participants who had positive MCED test results.

  2. Number of Additional Tests

    Time frame: MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.

    Number of additional tests is defined as total number of diagnostic tests performed to achieve final diagnostic resolution after the initial MCED test.

  3. Types of Additional Tests

    Time frame: MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.

    Types of additional tests are defined as the specific types of diagnostic tests performed to reach final diagnostic resolution after the initial MCED test.

  4. Tissue of Origin Correct Prediction Rate

    Time frame: MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.

    Tissue of origin correct prediction rate is defined as the proportion of participants in whom the tissue of origin predicted by the GRAIL Galleri® MCED test matches the confirmed cancer site, based on cancer status assessments.

  5. Qualitative Provider Assessment of MCED Test Utility

    Time frame: 24 months

    At the end of the study, participating providers will be surveyed to assess their attitudes, perceptions, and experiences regarding the utility and integration of MCED tests in clinical practice. The assessment includes multiple-choice questions, and open-ended questions.

Study contacts

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

Elizabeth O'Donnell, MD

CONTACT

[email protected]

857-215-2361

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

Determining ImpactS of Multi-Cancer Early detectiOn Tests oVER Time in Symptomatic Patients: The DISCOVER Study

Acronym: DISCOVERY

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 5, 2026
Registry last updated
Feb 5, 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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