The DISCOVER Study (DISCOVERY)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Cancer Diagnosis
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth O'Donnell, MD; Phone Number: 857-215-2361; Email: elizabeth_odonnell@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
      • Principal Investigator: Elizabeth ODonnell, MD
      • Contact: Elizabeth O'Donnell, MD; Phone Number: 857-215-2361; Email: elizabeth_odonnell@dfci.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Galleri MCED Test; 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	MCED positive cancer incidence is defined as the number of cancers detected by the MCED test.	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	MCED positive cancer stage is defined as the stage of cancer detected by the MCED test.	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	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).	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	MCED undetected cancer incidence is defined as the number of cancers detected by standard diagnostic methods that was not identified by the MCED test.	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	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.	MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
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.	MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.
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.	MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.
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.	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	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.	24 months

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Elizabeth O'Donnell, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Cancer Diagnosis
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 25-467

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No