Cancer
Conditions
Keywords
Liquid Biopsy, Blood Test, Cancer Diagnostic, Genomics, Multiomics, Artificial Intelligence, Screening, Machine Learning, Freenome, Early Detection, Multicancer, Cancer
Brief summary
This protocol is a case-control, multicenter, diagnostic study to collect blood samples to support the development of blood-based screening tests for 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 at least 30 years * Able and willing to provide blood samples per protocol * Able to comprehend and willing to sign and date the informed consent documents * Participants must meet one of the following: * Diagnosed with a single primary cancer that has not yet been treated * No evidence or treatment of any cancer for at least 5 years prior to enrollment Key
Exclusion criteria
* A medical condition which, in the opinion of the investigator, should preclude enrollment in the study * Known to be pregnant * Any therapy for cancer, including surgery, chemotherapy, 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 in the last 30 days * Participated in or currently participating in another Freenome clinical study * For the control cohort: 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 cohorts: 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