Clinical Sample Protocol for Plasma-based Colorectal Cancer Screening Research & Development
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colo-rectal Cancer
- Sponsor
- Epigenomics, Inc
- Enrollment
- 354
- Locations
- 5
- Primary Endpoint
- Test Positivity
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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.
Outcomes
Primary Outcomes
Test Positivity
Time Frame: Anticipated time frame for testing blood sample is within 12 months of collection
DNA methylation status of Epi proColon and biomarker panel