Newly-diagnosed Cancers, Non-cancer Controls
Conditions
Keywords
Liquid Biopsy, Blood Test, Cancer Diagnostic, Genomics, Multiomics, Artificial Intelligence, Screening, Machine Learning, Freenome, Early Detection, Multicancer
Brief summary
This protocol is a prospective, case-control multi-center diagnostic study to assess the sensitivity and specificity of blood-based screening tests for the early detection of multiple cancers.
Interventions
DIAGNOSTIC_TESTFreenome Test
Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled.
Sponsors
Freenome Holdings Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Age ≥30 years within 30 days of enrollment * Able and willing to provide blood samples per protocol * Able to comprehend and willing to sign and date the informed consent and HIPAA * Authorization documents * Able and willing to allow existing health data to be utilized for study purposes Key
Exclusion criteria
* Any history of solid organ or bone marrow transplantation * Any physical trauma or surgery requiring inpatient overnight hospitalization in the 30 days preceding enrollment * Received a blood transfusion in the 30 days preceding enrollment * A medical condition that, in the opinion of the Investigator, should preclude enrollment in the study * Known to be pregnant * Any therapy for cancer, including but not limited to surgery, chemotherapy, biologic therapy, immunotherapy, and/or radiation therapy in the 5 years preceding enrollment * Participated or currently participating in a clinical research study in which an experimental medication has been administered during the 30 days preceding enrollment * Participated or currently participating in another Freenome-sponsored clinical study * For non-cancer groups: Any previous cancer diagnosis in the 5 years preceding enrollment; OR recurrence of the same primary cancer within any timeframe; OR concurrent diagnosis of multiple primary cancers within any timeframe * For the cancer groups: Any previous cancer diagnosis in the 5 years preceding enrollment, apart from the current cancer diagnosis; OR recurrence of the same primary cancer within any timeframe; OR concurrent diagnosis of multiple primary cancers within any timeframe
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Blood Samples from Cancer Case and Non-cancer Control Participants | 12 months | To compare blood samples from cancer case and non-cancer control subjects in order to develop and characterize blood-based multiomics tests in specific cancer types or in a combination of multiple cancers. |
Countries
United States
Outcome results
None listed