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Not yet recruiting NCT07390643

The DISCOVER Study

No phase Interventional Cancer Cancer Diagnosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GRAIL Galleri MCED test.
Who it may be relevant to
Registry conditions: Cancer, Cancer Diagnosis. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed 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.

Interventions

  • Device GRAIL Galleri MCED test
    A multi-cancer early detection (MCED) blood test.

Primary outcome measures

  • 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.]
  • 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.]
  • 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.]
  • 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.]
  • 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.]
  • 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.]
Secondary outcome measures (5)
  • Positive Predictive Value (PPV) of Multi-cancer Early Detection (MCED) [Time frame: 12 months]
  • Number 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 [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 [Time frame: MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.]
  • Qualitative Provider Assessment of MCED Test Utility [Time frame: 24 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

United States · 1 center
  • Dana-Farber Cancer Institute — Boston

Identifiers

NCT: NCT07390643 · 25-467

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗