The DISCOVER Study
DISCOVERY
Determining ImpactS of Multi-Cancer Early detectiOn Tests oVER Time in Symptomatic Patients: The DISCOVER Study
1 other identifier
interventional
100
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started Jul 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2026
CompletedFirst Posted
Study publicly available on registry
February 5, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
Study Completion
Last participant's last visit for all outcomes
January 31, 2028
February 5, 2026
January 1, 2026
7 months
January 26, 2026
February 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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 Outcomes (5)
Positive Predictive Value (PPV) of Multi-cancer Early Detection (MCED)
12 months
Number of Additional Tests
MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.
Types of Additional Tests
MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.
Tissue of Origin Correct Prediction Rate
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
24 months
Study Arms (1)
Galleri MCED Test
EXPERIMENTALEnrolled 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth O'Donnell, MD
Dana-Farber Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 26, 2026
First Posted
February 5, 2026
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2028
Last Updated
February 5, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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.