Cancer, Cancer Diagnosis
Conditions
Keywords
Cancer, Cancer Diagnosis
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
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.
Interventions
DEVICEGRAIL Galleri MCED test
A multi-cancer early detection (MCED) blood test.
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Multi-cancer Early Detection (MCED) Positive Cancer Type | 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 | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive Predictive Value (PPV) of Multi-cancer Early Detection (MCED) | 12 months | 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. |
| Number of Additional Tests | 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. |
| Types 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 are defined as the specific types of diagnostic tests performed to reach final diagnostic resolution after the initial MCED test. |
| Tissue of Origin Correct Prediction Rate | MCED testing will be performed at enrollment, with diagnostic resolution and cancer type determination expected within 12 months. | 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. |
| Qualitative Provider Assessment of MCED Test Utility | 24 months | 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. |
Countries
United States
Contacts
CONTACTElizabeth O'Donnell, MD
PRINCIPAL_INVESTIGATORElizabeth O'Donnell, MD
Dana-Farber Cancer Institute
Outcome results
None listed