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

Study Overview
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Brief Summary
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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.

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

Conditions
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Newly-diagnosed Cancers, Non-cancer Controls

Intervention / Treatment
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* Diagnostic Test: Freenome Test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer Group<br>Collect Subject Data Collect Blood Specimen | Diagnostic Test: Freenome Test<br>* Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled.<br>|
| Non-cancer Group<br>Collect Subject Data Collect Blood Specimen | Diagnostic Test: Freenome Test<br>* Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Blood Samples from Cancer Case and Non-cancer Control Participants | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Test, Liquid Biopsy, Cancer Diagnostic, Genomics, Multiomics, Artificial Intelligence, Screening, Machine Learning, Freenome, Early Detection, Multicancer