Colo-rectal Cancer
Conditions
Keywords
plasma, cell-free DNA, DNA Methylation
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.
Interventions
DIAGNOSTIC_TESTEpi proColon
Analysis of DNA methylation status for Septin9 and additional biomarkers
Sponsors
Epigenomics, Inc
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 84 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Test Positivity | Anticipated time frame for testing blood sample is within 12 months of collection | DNA methylation status of Epi proColon and biomarker panel |
Countries
United States
Outcome results
None listed