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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Galleri MCED Test | Experimental | Enrolled participants will complete:
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GRAIL Galleri MCED test | Device | A multi-cancer early detection (MCED) blood test. |
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| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth O'Donnell, MD | Contact | 857-215-2361 | Elizabeth_odonnell@dfci.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth O'Donnell, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 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. |
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 |