Overview
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.
Eligibility
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