The Sanderson Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening

The Sanderson Study: A Diagnostic Case-Control Study for the Development of Multiomics Blood Tests for Cancer Screening in a Real World Setting

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.

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