The Vallania 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 case-control, multicenter, diagnostic study to collect blood samples to support the development of blood-based screening tests for multiple cancers.

Official Title
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The Vallania Study: A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening

Conditions
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Cancer

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 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

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 One Year Follow Up On Cancer Status | 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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Freenome, Early Detection, Multicancer, Cancer, Liquid Biopsy, Blood Test, Cancer Diagnostic, Genomics, Multiomics, Artificial Intelligence, Screening, Machine Learning