PRESEPT Study: Evaluation of SEPT9 Biomarker Performance for Colorectal Cancer Screening (PRESEPT)

PRESEPT Study: Prospective Evaluation of Septin 9 Performance for Colorectal Cancer Screening

The purpose of this study is to collect blood specimens and clinical data from screening guideline eligible individuals designated by their physician to receive a screening colonoscopy, and to evaluate the performance of a colorectal cancer-specific DNA methylation biomarker for detection of colorectal cancer in this cohort. Based on the outcome of the colonoscopy, polypectomy, biopsy and surgical tissue histopathology, the clinical utility of Septin 9 as colorectal cancer screening test will be evaluated.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: All eligible subjects will provide blood for SEPT9 biomarker testing

Detailed Description

The study is designed as a prospective, open enrollment clinical investigation involving multiple clinical study sites in the United States and Germany. Subjects will be competitively enrolled at multiple sites until at least 50 invasive colorectal adenocarcinoma cases identified by screening colonoscopy and verified by clinical and histopathological examination have been enrolled. The primary objective of the investigation is to evaluate and describe the clinical performance of the Septin 9 Biomarker for detecting the 50 individuals with invasive colorectal adenocarcinoma identified in this population representative of the US screening guideline eligible population. Secondary objectives will be to evaluate and describe performance characteristics of the biomarker in individuals with adenomatous polyps 10 mm or larger, flat lesion (s) or non-invasive adenocarcinoma.

Collaborating sites will identify and contact patients scheduled for screening colonoscopy. These patients may be screened by the PI or designee to determine the patients' appropriateness for, and interest in, study participation. Study site personnel will meet with patients meeting eligibility guidelines and offer them participation. Patients interested in participation and who provide written informed consent will be enrolled as Subjects in the study.

• Study Type: Observational
• Enrollment (Actual): 7929

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Berlin Private-Practice Gastroenterology Working Group
  • Hamburg, Germany, 20246
    • University of Hamburg-Eppendorf
  • Munich, Germany
    • Technical University of Munich
• United States
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Digestive Care
    • Miami, Florida, United States, 33173
      • GI Care Center
  • Georgia
    • Atlanta, Georgia, United States, 30134
      • Atlanta Gastroenterology Associates
  • Illinois
    • Rockford, Illinois, United States, 61107
      • Rockford Gastroenterology Associates, Ltd.
  • Iowa
    • Clive, Iowa, United States, 50325
      • Heartland Medical Research, Inc.
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Minnesota Gastroenterology
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Jackson Gastrointestinal Associates
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Asheville Gastroenterology Associates PA
    • New Bern, North Carolina, United States, 28562
      • Southern Gastroenterology Associates
    • Winston-Salem, North Carolina, United States, 27103
      • Digestive Health Specialists
  • Oregon
    • Portland, Oregon, United States, 97220
      • The Oregon Clinic
    • Portland, Oregon, United States, 97210
      • Northwest Gastroenterology Clinic
    • Portland, Oregon, United States, 97205
      • The Portland Clinic
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17604
      • Regional Gastroenterology Associates of Lancaster, Ltd.
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina Digestive Disease Center
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Gastroenterology Center Of The Midsouth
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research
  • Washington
    • Bellevue, Washington, United States, 98008
      • Northwest Gastroenterology Associates
    • Tacoma, Washington, United States, 98405
      • Tacoma Digestive Disease Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted in Subjects scheduled for screening colonoscopy according to current U.S. CRC screening guidelines.

Description

Inclusion Criteria:

• Informed Consent provided
• Capable of providing adequate health history
• Age 50 or older at time of colonoscopy (colorectal screening guideline eligible)
• Accessible for blood draw prior to start of bowel preparation for colonoscopy
• First large bowel endoscopy in lifetime

Exclusion Criteria:

• Anorectal bleeding or hematochezia within last 6 months for which patient sought medical attention
• Known iron deficiency anemia in the last 6 months for which patient sought medical attention
• Previous history of colorectal polyps or CRC
• High risk for colorectal cancer (2 or more 10 relatives with CRC; 1 or more 10 relative(s) < 50 years with CRC; known HNPCC or FAP)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adults > 50 Years Scheduled for Colonscopy; Average to increased risk adults older than 50 years without symptoms indicative of CRC and designated for colonoscopy.	Other: All eligible subjects will provide blood for SEPT9 biomarker testing; A single blood sample per participant selected according to analysis plan is tested for evidence of methylation of a specific DNA sequence, SEPT9.; Other Names: biomarker; blood; colorectal cancer; DNA methylation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical/surgical diagnosis of invasive colorectal adenocarcinoma detected by optical colonoscopy and confirmed by histology compared to the Septin 9 Biomarker classification.	One Year

Secondary Outcome Measures

Outcome Measure	Time Frame
Detection of adenomatous polyp(s) equal to or greater than 10 mm, flat lesion (s) or non-invasive adenocarcinoma by colonoscopy and confirmed by histology compared to the Septin 9 Biomarker classification will also be described.	One Year

Collaborators and Investigators

• Sponsor: Epigenomics, Inc
• Investigators: Principal Investigator: Timothy R Church, Ph.D., University of Minnesota; Study Director: Michael Wandell, PharmD., Epigenomics, Inc; Study Chair: David F Ransohoff, MD, University of North Carolina

Publications and helpful links

General Publications

• Payne SR, Church TR, Wandell M, Rosch T, Osborn N, Snover D, Day RW, Ransohoff DF, Rex DK. Endoscopic detection of proximal serrated lesions and pathologic identification of sessile serrated adenomas/polyps vary on the basis of center. Clin Gastroenterol Hepatol. 2014 Jul;12(7):1119-26. doi: 10.1016/j.cgh.2013.11.034. Epub 2013 Dec 10.
• Church TR, Wandell M, Lofton-Day C, Mongin SJ, Burger M, Payne SR, Castanos-Velez E, Blumenstein BA, Rosch T, Osborn N, Snover D, Day RW, Ransohoff DF; PRESEPT Clinical Study Steering Committee, Investigators and Study Team. Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer. Gut. 2014 Feb;63(2):317-25. doi: 10.1136/gutjnl-2012-304149. Epub 2013 Feb 13.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: February 4, 2009
• First Submitted That Met QC Criteria: March 2, 2009
• First Posted (Estimate): March 4, 2009

Study Record Updates

• Last Update Posted (Estimate): August 4, 2014
• Last Update Submitted That Met QC Criteria: August 1, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: colorectal cancer; early detection; methylation, biomarker
• 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: Epigenomics_SPR0006