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

Completed

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT00855348

Run by

Epigenomics, Inc

People needed

7929

Starts

2008-06-01

Expected to finish

2010-04-01

Last updated by the study team

2014-08-04

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

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)

Where it is running

• 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
• The Portland Clinic — Portland, Oregon, United States
• Northwest Gastroenterology Clinic — Portland, Oregon, United States
• The Oregon 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
• Berlin Private-Practice Gastroenterology Working Group — Berlin, Germany
• University of Hamburg-Eppendorf — Hamburg, Germany
• Technical University of Munich — Munich, Germany

Full record on ClinicalTrials.gov

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