Spots Global Cancer Trial Database for PRESEPT Study: Evaluation of SEPT9 Biomarker Performance for Colorectal Cancer Screening
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Trial Identification
Brief Title: PRESEPT Study: Evaluation of SEPT9 Biomarker Performance for Colorectal Cancer Screening
Official Title: PRESEPT Study: Prospective Evaluation of Septin 9 Performance for Colorectal Cancer Screening
Study ID: NCT00855348
Conditions
Study Description
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.
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.
Eligibility
Minimum Age: 50 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
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
Contact Details
Name: Timothy R Church, Ph.D.
Affiliation: University of Minnesota
Role: PRINCIPAL_INVESTIGATOR
Name: Michael Wandell, PharmD.
Affiliation: Epigenomics, Inc
Role: STUDY_DIRECTOR
Name: David F Ransohoff, MD
Affiliation: University of North Carolina
Role: STUDY_CHAIR
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