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.

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

Colorectal Cancer

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.

All eligible subjects will provide blood for SEPT9 biomarker testing

PRESEPT Study: Prospective Evaluation of Septin 9 Performance for Colorectal Cancer Screening

Average to increased risk adults older than 50 years without symptoms indicative of CRC and designated for colonoscopy.

Digestive Care

GI Care Center

Atlanta Gastroenterology Associates

Rockford Gastroenterology Associates, Ltd.

Heartland Medical Research, Inc.

University of Louisville

Minnesota Gastroenterology

Jackson Gastrointestinal Associates

Asheville Gastroenterology Associates PA

Southern Gastroenterology Associates

Digestive Health Specialists

The Portland Clinic

Northwest Gastroenterology Clinic

The Oregon Clinic

Regional Gastroenterology Associates of Lancaster, Ltd.

Medical University of South Carolina Digestive Disease Center

Gastroenterology Center of the MidSouth

Charlottesville Medical Research

Northwest Gastroenterology Associates

Tacoma Digestive Disease Research Center

Berlin Private-Practice Gastroenterology Working Group

University of Hamburg-Eppendorf

Technical University of Munich

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

About this trial

Study ID

Status

Type

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?