Plasma-based Colorectal Cancer Screening Research & Development

Study Overview
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Brief Summary
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The objective of this Clinical Sample Collection Study is to develop a biobank of appropriately collected plasma samples from colorectal cancer patients (i.e. AJCC/UICC stages 0, I, II, III) prior to therapeutic intervention, and from people reporting for colorectal cancer screening by colonoscopy, prior to bowel preparation.

Detailed Description
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The objective of this Clinical Sample Collection Study is to develop a biobank of appropriately collected plasma samples from colorectal cancer patients (i.e. AJCC/UICC stages 0, I, II, III) prior to therapeutic intervention, and from people reporting for colorectal cancer screening by colonoscopy, prior to bowel preparation. Samples in the colorectal cancer biobank will be used to: 1) assess the clinical performance of novel biomarkers for colorectal cancer screening; 2) develop improved processing workflows for the Epi proColon® test; 3) develop an automated Epi BiSKit workflow.

Official Title
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Clinical Sample Protocol for Plasma-based Colorectal Cancer Screening Research & Development

Conditions
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Colo-rectal Cancer

Intervention / Treatment
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* Diagnostic Test: Epi proColon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Group 1 Willing and able to sign an Informed Consent and adhere to study requirements. Subjects with colorectal cancer preferably detected by screening (any guideline recommended modality). Colonoscopy diagnosis of colorectal cancer (CRC).* Blood sampling a minimum of 7 days after colonoscopy and before resection surgery. = Strong clinical suspicion of colorectal carcinoma is also acceptable for subject enrollment; Case must have a confirmed diagnosis after surgery of CRC and be accompanied by a complete final pathology report. Inclusion Criteria: Group 2 Willing and able to sign an Informed Consent and adhere to study requirements. Eligible for colorectal cancer screening colonoscopy. 45 - 84 years of age at blood sampling. Able to provide blood sample within up to 2 weeks prior to bowel prep and colonoscopy. Exclusion Criteria: Group 1 Subject with curative biopsy during colonoscopy. Current neoadjuvant treatment. Current diagnosis of any cancer other than CRC, except non-melanoma skin cancer. Known infection with HIV, HBV or HCV. Exclusion Criteria: Group 2 Previous personal history of CRC, adenomatous polyps >10mm or sessile serrated adenomas (polyps). Familial risk for colorectal cancer (1 or more 1st degree relatives with CRC; known HNPCC or FAP). History of inflammatory bowel disease. Current neoadjuvant treatment. Current diagnosis of any cancer other than CRC, except non-melanoma skin cancer. infection with HIV, HBV or HCV.

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 |
| --- | --- |
| Group 1 - Cancer Patients<br>Subjects with known colorectal cancer (i.e. AJCC/UICC stages 0, I, II, and III) who provide plasma at least 7 days after diagnosis by colonoscopy, but prior to surgery or treatment | Diagnostic Test: Epi proColon<br>* Analysis of DNA methylation status for Septin9 and additional biomarkers<br>|
| Group 2 - Screening Subjects<br>Prospectively enrolled subjects reporting for screening colonoscopy who provide a blood sample up to 2 weeks prior to bowel prep and prior to colonoscopy. We accept all subjects who meet the institutional criteria as average risk subjects referred for a screening colonoscopy for colorectal cancer, including subjects undergoing a colonoscopy as a follow-up to a positive (non-colonoscopic) test | Diagnostic Test: Epi proColon<br>* Analysis of DNA methylation status for Septin9 and additional biomarkers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test Positivity | DNA methylation status of Epi proColon and biomarker panel | Anticipated time frame for testing blood sample is within 12 months of collection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plasma, cell-free DNA, DNA Methylation