Clinical trialNCT00855348CompletedObservational

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

SponsorEpigenomics, IncEnrollment7,929Colorectal Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

David F Ransohoff, MD
University of North Carolina
Study Chair
clinicaltrials.gov ↗
Michael Wandell, PharmD.
Epigenomics, Inc
Study Director
clinicaltrials.gov ↗
Timothy R Church, Ph.D.
University of Minnesota
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

23 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Germany

Berlin Private-Practice Gastroenterology Working Group
Berlin, Germany
University of Hamburg-Eppendorf
Hamburg, Germany
Technical University of Munich
Munich, Germany

United States

Digestive Care
Boca Raton, Florida, United States
Gi Care Center
Miami, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, United States
Heartland Medical Research, Inc.
Clive, Iowa, United States
University of Louisville
Louisville, Kentucky, United States
Minnesota Gastroenterology
Minneapolis, Minnesota, United States
Jackson Gastrointestinal Associates
Jackson, Mississippi, United States
Asheville Gastroenterology Associates Pa
Asheville, North Carolina, United States
Southern Gastroenterology Associates
New Bern, North Carolina, United States
Digestive Health Specialists
Winston-Salem, North Carolina, United States
Northwest Gastroenterology Clinic
Portland, Oregon, United States
the Oregon Clinic
Portland, Oregon, United States
the Portland Clinic
Portland, Oregon, United States
Regional Gastroenterology Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, United States
Medical University of South Carolina Digestive Disease Center
Charleston, South Carolina, United States
Gastroenterology Center of the Midsouth
Germantown, Tennessee, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Northwest Gastroenterology Associates
Bellevue, Washington, United States
Tacoma Digestive Disease Research Center
Tacoma, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study — it may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Jun 2008
Primary completion: 31 Jan 2010
Completion: 30 Apr 2010
Last update posted: 4 Aug 2014
Registered enrollment: 7,929
Registry id: NCT00855348

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.