Collection of Samples USOPTIVAL Study

Study Overview
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Brief Summary
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A prospective multi-center observational study. The study will enroll eligible subjects from the United States to optimize the biomarker panel and evaluate the performance of a cfDNA marker panel selected by the Sponsor for CRC and advanced adenoma detection.

Detailed Description
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This study is designed to prospectively collect blood samples and clinical data from subjects that have a suspected advanced adenoma or have been newly diagnosed with CRC scheduled for resection surgery, as well as subjects who are at average-risk of colorectal cancer and who are scheduled for routine colonoscopy examination. Subjects interested in participation and who meet inclusion criteria and provide written informed consent will be enrolled in the study. By accepting participation in the study, subjects will consent to provide up to 40 ml of blood at the study visit.

Official Title
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Collection of Samples From the United States Population for Optimization and Evaluation of Colorectal Cancer (CRC) Plasma Circulating Free-DNA (cfDNA) Marker Panel Performance (USOPTIVAL)

Conditions
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Colorectal Cancer (CRC), Advanced Adenomas (AA)

Intervention / Treatment
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* Diagnostic Test: Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Arm A: Must be 45-84 years of age. Must have a suspected advanced adenoma or be newly diagnosed with CRC, still not resected, and scheduled for surgery. Able to comprehend, sign, and date the written informed consent document. Arm B: Must be 45-84 years of age. Able and willing to undergo a standard-of-care screening colonoscopy within 60 days. Able to comprehend, sign, and date the written informed consent document. Exclusion Criteria: Arm A Only: 1. Subject with curative biopsy during colonoscopy. Arm B Only: Subjects with positive FIT Test results in the 6 months preceding enrollment. Subject has a current diagnosis of cancer. Arms A & B: Subject has a personal history of aerodigestive or digestive tract cancers. Subjects having undergone previous partial surgical removal of one or more portions of their colon due to a reason other than colorectal cancer. Has a known diagnosis or personal history of any of the following high-risk indications for colorectal cancer: Inflammatory bowel disease (IBD) including chronic ulcerative colitis (CUC) and Crohn's disease. Familial adenomatous polyposis (FAP, including attenuated FAP). Hereditary non-polyposis colorectal cancer syndrome (HNPCC or Lynch Syndrome). Serrated polyposis syndrome 2 first-degree relatives (e.g., parents, siblings, and offspring) who have been diagnosed with colon cancer. One first-degree relative with CRC diagnosed before the age of 60. A significant disease which, in the Investigator's opinion, would exclude the subject from the study. Legal incapacity or limited mental capacity. Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent. The patient has a known or documented previous or current medical history of infectious diseases that can be transmitted through blood (E.g. Hepatitis, HIV, etc.), including patients that have been treated, are currently being treated, or have not been treated for that conditions. The patient is known to be pregnant when recruited or during her participation in the study.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 84 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 |
| --- | --- |
| Arm A.<br>Subjects that have a suspected advanced adenoma or have been newly diagnosed with CRC still not resected and scheduled for surgery | Diagnostic Test: Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel<br>* Evaluate the performance of a preliminary panel of biomarkers<br>|
| Arm B<br>Subjects at average-risk for CRC and scheduled for CRC screening colonoscopy | Diagnostic Test: Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel<br>* Evaluate the performance of a preliminary panel of biomarkers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Samples Collected for Plasma Circulating Free-DNA (cfDNA) Marker Testing | Samples Collected for Testing | Within 12 months of sample collection |