PRESEPT Study: Prospective Evaluation of Septin 9 Performance for Colorectal Cancer Screening
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.
Observational Model: Cohort, Time Perspective: Prospective
Clinical/surgical diagnosis of invasive colorectal adenocarcinoma detected by optical colonoscopy and confirmed by histology compared to the Septin 9 Biomarker classification.
Timothy R Church, Ph.D.
University of Minnesota - Clinical and Translational Science Institute
United States: Institutional Review Board
|Northwest Gastroenterology Associates||Bellevue, Washington 98004|
|University of Louisville||Louisville, Kentucky 40202|
|Atlanta Gastroenterology Associates||Atlanta, Georgia|
|The Oregon Clinic||Portland, Oregon 97213|
|Minnesota Gastroenterology||Plymouth, Minnesota 55446|
|Northwest Gastroenterology Clinic||Portland, Oregon 97210|
|Charlottesville Medical Research||Charlottesville, Virginia 22911|
|Digestive Care||Boca Raton, Florida 33486|
|GI Care Center||Miami, Florida 33173|
|Rockford Gastroenterology Associates, Ltd.||Rockford, Illinois 61107|
|Heartland Medical Research, Inc.||Clive, Iowa 50325|
|Jackson Gastrointestinal Associates||Jackson, Mississippi 39202|
|Asheville Gastroenterology Associates PA||Asheville, North Carolina 28801|
|Southern Gastroenterology Associates||New Bern, North Carolina 28562|
|Digestive Health Specialists||Winston-Salem, North Carolina 27103|
|The Portland Clinic||Portland, Oregon 97205|
|Regional Gastroenterology Associates of Lancaster, Ltd.||Lancaster, Pennsylvania 17604|
|Medical University of South Carolina Digestive Disease Center||Charleston, South Carolina 29425|
|Gastroenterology Center of the MidSouth||Germantown, Tennessee 38138|
|Tacoma Digestive Disease Research Center||Tacoma, Washington 98405|