CancerDISCOVERYNCT07390643
The DISCOVER Study
A study testing GRAIL Galleri MCED test in people with Cancer and Cancer Diagnosis, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Cancer Diagnosis
- What is being tested?
- GRAIL Galleri MCED test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Elizabeth O'Donnell, MD, 857-215-2361, elizabeth_odonnell@dfci.harvard.edu
Elizabeth ODonnell, MD
About this study
Official title: 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
Read the 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.
- Conditions
- Cancer, Cancer Diagnosis
- Being tested
- GRAIL Galleri MCED test
- Keywords
- Cancer, Cancer Diagnosis
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRAIL Galleri MCED testDevice
A multi-cancer early detection (MCED) blood test.
| Study group | Role | What they receive |
|---|---|---|
| Galleri MCED Test | Experimental | 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 Receives: Device: GRAIL Galleri MCED test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study startJul 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth ODonnell, Dana-Farber Cancer Institute
- Investigators
- Elizabeth O'Donnell, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390643
- Sponsor's protocol ID
- 25-467
- Acronym
- DISCOVERY
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining ImpactS of Multi-Cancer Early detectiOn Tests oVER Time in Symptomatic Patients: The DISCOVER Study
- ClinicalTrials.gov ID
- NCT07390643
- Acronym / sponsor ID
- DISCOVERY / 25-467
- Conditions
- Cancer, Cancer Diagnosis
- Keywords
- Cancer, Cancer Diagnosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Galleri MCED Test | Experimental | Device: GRAIL Galleri MCED testEnrolled 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 |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GRAIL Galleri MCED testA multi-cancer early detection (MCED) blood test. | Device | Galleri MCED Test |
Primary outcome
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).
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.
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.
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).
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.
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth O'Donnell, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GRAIL Galleri MCED test in people with Cancer and Cancer Diagnosis, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth O'Donnell, MD (857-215-2361, Elizabeth_odonnell@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.