Avera/Sema4 Oncology and Analytics Protocol

Study Overview
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Brief Summary
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The purpose of this study is to understand the breadth of molecular characteristics present in participants cared for in a large integrated, community-based health care system. Using comprehensive genomic profiling and proteomics, the investigators seek to identify the underlying genomic drivers of premalignant or malignant conditions in participants across different stages of disease development and cancer types. Comprehensive molecular profiling will consist of somatic tumor testing (tissue and/or blood) using whole exome sequencing, whole transcriptome sequencing, proteomics, and selected instances of whole genome sequencing. In addition, the investigators seek to perform broad hereditary cancer testing in affected participant populations. Hereditary testing has implications in screening, prognosis, and therapeutics for affected participants, as well as broad implications for genetic counseling and cascade testing. In order to maximize the value of genomic information, participants consented to this protocol will have their electronic health records (both retrospectively and prospectively) abstracted, curated, annotated and linked to genomic information obtained though the testing performed. Given the long-term value of this data, participants will also be asked to voluntarily consent to have their samples stored in a biobank and have their de-identified information used for future research. Information collected across this participant population will aid in advancing the investigators' knowledge of cancer biology, to discover and validate biomarkers associated with clinical outcomes, and shared in collaborative projects in order to promote the study of cancer.

Official Title
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Implementation of Comprehensive Molecular Profiling and Deep Clinical Annotation of Electronic Health Records in Participants Diagnosed With a Malignancy or at Risk of Developing Cancer

Conditions
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Cancer, Cancer Diagnosis, Early Detection of Cancer, Breast Cancer, Lung Cancer, Colon Cancer, GI Cancer, Gynecologic Cancer, Ovarian Cancer, Endometrial Cancer, CNS Cancer, Hematologic Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be at least 18 years of age Must be undergoing a workup or being followed for a premalignant condition or have a diagnosis of cancer Must voluntarily sign and understand the most current IRB-approved consent form prior to study participation Exclusion Criteria: Participants incapable of understanding the items listed in the consent form and process Participants with a history of or known psychiatric illness deemed unable to consent or adhere to study requirements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients participating in comprehensive molecular profiling |  | 5 years | 
| Percent of patients referred for cascade genetic testing |  | 5 years | 
| Percent of patients referred for molecularly targeted clinical trials |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients that had therapy changed due to comprehensive molecular profiling |  | 5 years | 
| Percent of patients that had therapy changed due to pharmacogenomic testing |  | 5 years | 
| Percent of patient participating in microbiome collection and analysis |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Genomics, Genetics, Microbiome, Pharmacogenomics