Prevention of Colorectal Cancer Through Multiomics Blood Testing

Study Overview
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Brief Summary
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The PREEMPT CRC study is a prospective multi-center observational study to validate a blood-based test for the early detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.

Detailed Description
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Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in blood to detect cancer early. The purpose of this prospective multi-center observational study is to validate a blood-based test for the detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.

Official Title
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Prevention of Colorectal Cancer Through Multiomics Blood Testing

Conditions
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Colon Cancer, Rectal Cancer, Colon Neoplasm, Colon Diseases, Colon Lesion, Colon Polyp, Colorectal Cancer, Polyp, Adenoma, Rectal Diseases, Gastrointestinal Tract Cancers

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 45-85 years of age Willing to undergo a standard-of-care screening colonoscopy Able and willing to provide a blood sample Able and willing to sign informed consent Key Exclusion Criteria Known hereditary gastrointestinal cancer syndrome (for example, hereditary non-polyposis CRC syndrome (HNPCC) or Lynch syndrome, or familial adenomatous polyposis (FAP) Personal history 2.1 CRC or colorectal adenoma 2.2 Inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and crohn's disease (CD) 2.3 Colonoscopy in the 9 years preceding enrollment 2.4 Stool DNA testing in the 2 years preceding enrollment 2.5 Symptoms of lower gastrointestinal tract disease warranting colonoscopic evaluation A medical condition which, in the opinion of the Investigator, should preclude enrollment in the study Participated or currently participating in a clinical research study in which an experimental medication has been administered during the 60 days up to and including the date of providing informed consent or may be administered through the time of the colonoscopy

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Freenome test|Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled. Participants will undergo blood collection and will then complete a standard-of-care screening colonoscopy.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity for CRC of the Freenome test |  | 90 days | 
| Specificity of the Freenome test |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRC, Artificial Intelligence, Liquid Biopsy, Blood Test Cancer, Cancer Diagnostic, Genomics, Genomics Test, Cancer Screening, Cancer Early Detection Test, Screening, Colonoscopy, Machine Learning, Freenome Test, Colorectal Cancer (CRC), Colorectal Cancer Screening