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

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

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.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)