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

NCT00855348 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 7929

Last updated 2014-08-04

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Epigenomics, Inc

    lead INDUSTRY

Principal Investigators

  • Timothy R Church, Ph.D. · University of Minnesota

  • Michael Wandell, PharmD. · Epigenomics, Inc

  • David F Ransohoff, MD · University of North Carolina

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-01-31
Completion
2010-04-30

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00855348 on ClinicalTrials.gov