Plasma-based Colorectal Cancer Screening Research & Development

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

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.

Study Overview

• Status: Completed
• Conditions: Colo-rectal Cancer
• Intervention / Treatment: Diagnostic test: Epi proColon

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.

• Study Type: Observational
• Enrollment (Actual): 354

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Illinois
    • Springfield, Illinois, United States, 62702
      • Springfield Clinic
  • Louisiana
    • New Orleans, Louisiana, United States, 70170
      • Ochsner Clinic Foundation
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Perelman Center for Advanced Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 84 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Women and Men age 45-84 reporting for screening colonoscopy (Group 2) or with known colorectal cancer, prior to intervention (Group 1).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 - Cancer Patients; 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; Analysis of DNA methylation status for Septin9 and additional biomarkers
Group 2 - Screening Subjects; 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; Analysis of DNA methylation status for Septin9 and additional biomarkers

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Epigenomics, Inc

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 3, 2019
• Primary Completion (ACTUAL): March 31, 2020
• Study Completion (ACTUAL): March 31, 2020

Study Registration Dates

• First Submitted: June 6, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (ACTUAL): July 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: cell-free DNA; DNA Methylation; plasma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: ECS0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No