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The DISCOVER Study

ConditionsCancerCancer Diagnosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorDana-Farber Cancer Institute

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • GRAIL Galleri MCED test

    Device

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Galleri MCED TestExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Multi-cancer Early Detection (MCED) Positive Cancer Type

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).

Time frame
MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.
2

Multi-cancer Early Detection (MCED) Positive Cancer Incidence

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

Time frame
MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.
3

Multi-cancer Early Detection (MCED) Positive Cancer Stage

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

Time frame
MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.
4

Multi-cancer Early Detection (MCED) Undetected Cancer Type

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).

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

Secondary outcomes

1

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

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.

Time frame
12 months
2

Number of Additional Tests

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

Time frame
MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.
3

Types of Additional Tests

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

Time frame
MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.
4

Tissue of Origin Correct Prediction Rate

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dana-Farber Cancer Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: