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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
100
A multi-cancer early detection (MCED) blood test.
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
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).
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
MCED positive cancer incidence is defined as the number of cancers detected by the MCED test.
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
MCED positive cancer stage is defined as the stage of cancer detected by the MCED test.
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
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).
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
MCED undetected cancer incidence is defined as the number of cancers detected by standard diagnostic methods that was not identified by the MCED test.
Time frame: MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months.
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.
Time frame: 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.
Time frame: 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.
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
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.
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
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.
Time frame: 24 months