Trial Information

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.