PRESEPT Study: Evaluation of SEPT9 Biomarker Performance for Colorectal Cancer Screening
PRESEPT
PRESEPT Study: Prospective Evaluation of Septin 9 Performance for Colorectal Cancer Screening
1 other identifier
observational
7,929
2 countries
23
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2008
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 4, 2009
CompletedFirst Posted
Study publicly available on registry
March 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedAugust 4, 2014
August 1, 2014
1.6 years
February 4, 2009
August 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (1)
Adults > 50 Years Scheduled for Colonscopy
Average to increased risk adults older than 50 years without symptoms indicative of CRC and designated for colonoscopy.
Interventions
A single blood sample per participant selected according to analysis plan is tested for evidence of methylation of a specific DNA sequence, SEPT9.
Eligibility Criteria
The study will be conducted in Subjects scheduled for screening colonoscopy according to current U.S. CRC screening guidelines.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Epigenomics, Inclead
Study Sites (23)
Digestive Care
Boca Raton, Florida, 33486, United States
GI Care Center
Miami, Florida, 33173, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30134, United States
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, 61107, United States
Heartland Medical Research, Inc.
Clive, Iowa, 50325, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Minnesota Gastroenterology
Minneapolis, Minnesota, 55455, United States
Jackson Gastrointestinal Associates
Jackson, Mississippi, 39202, United States
Asheville Gastroenterology Associates PA
Asheville, North Carolina, 28801, United States
Southern Gastroenterology Associates
New Bern, North Carolina, 28562, United States
Digestive Health Specialists
Winston-Salem, North Carolina, 27103, United States
The Portland Clinic
Portland, Oregon, 97205, United States
Northwest Gastroenterology Clinic
Portland, Oregon, 97210, United States
The Oregon Clinic
Portland, Oregon, 97220, United States
Regional Gastroenterology Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, 17604, United States
Medical University of South Carolina Digestive Disease Center
Charleston, South Carolina, 29425, United States
Gastroenterology Center of the MidSouth
Germantown, Tennessee, 38138, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Northwest Gastroenterology Associates
Bellevue, Washington, 98008, United States
Tacoma Digestive Disease Research Center
Tacoma, Washington, 98405, United States
Berlin Private-Practice Gastroenterology Working Group
Berlin, Germany
University of Hamburg-Eppendorf
Hamburg, 20246, Germany
Technical University of Munich
Munich, Germany
Related Publications (2)
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.
PMID: 24333512DERIVEDChurch 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.
PMID: 23408352DERIVED
Biospecimen
Eligible consented Subjects meeting inclusion / exclusion criteria will have 40 ml of blood drawn prior to undergoing bowel cleansing in preparation for screening colonoscopy. Subject blood specimens will be processed according to Epigenomics' plasma preparation procedure (Blood Collection and Plasma Preparation SOP.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 4, 2009
First Posted
March 4, 2009
Study Start
June 1, 2008
Primary Completion
January 1, 2010
Study Completion
April 1, 2010
Last Updated
August 4, 2014
Record last verified: 2014-08