Clinical trial NCT00855348: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: colorectal cancer
early detection
methylation, biomarker
Lead sponsor: Epigenomics, Inc
Sponsor class: INDUSTRY
First posted: 2009-03-04
Enrollment: 7929
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted in Subjects scheduled for screening colonoscopy according to current U.S. CRC screening guidelines.

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 criteria: 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)

Primary outcomes:
measure: Clinical/surgical diagnosis of invasive colorectal adenocarcinoma detected by optical colonoscopy and confirmed by histology compared to the Septin 9 Biomarker classification.
timeFrame: One Year
Secondary outcomes:
measure: Detection of adenomatous polyp(s) equal to or greater than 10 mm, flat lesion (s) or non-invasive adenocarcinoma by colonoscopy and confirmed by histology compared to the Septin 9 Biomarker classification will also be described.
timeFrame: One Year
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Digestive Care
state: Florida
city: Miami
country: United States
facility: GI Care Center
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Rockford
country: United States
facility: Rockford Gastroenterology Associates, Ltd.
state: Illinois
city: Clive
country: United States
facility: Heartland Medical Research, Inc.
state: Iowa
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Minneapolis
country: United States
facility: Minnesota Gastroenterology
state: Minnesota
city: Jackson
country: United States
facility: Jackson Gastrointestinal Associates
state: Mississippi
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates PA
state: North Carolina
city: New Bern
country: United States
facility: Southern Gastroenterology Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Digestive Health Specialists
state: North Carolina
city: Portland
country: United States
facility: The Portland Clinic
state: Oregon
city: Portland
country: United States
facility: Northwest Gastroenterology Clinic
state: Oregon
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
city: Lancaster
country: United States
facility: Regional Gastroenterology Associates of Lancaster, Ltd.
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina Digestive Disease Center
state: South Carolina
city: Germantown
country: United States
facility: Gastroenterology Center of the MidSouth
state: Tennessee
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Bellevue
country: United States
facility: Northwest Gastroenterology Associates
state: Washington
city: Tacoma
country: United States
facility: Tacoma Digestive Disease Research Center
state: Washington
city: Berlin
country: Germany
facility: Berlin Private-Practice Gastroenterology Working Group
city: Hamburg
country: Germany
facility: University of Hamburg-Eppendorf
city: Munich
country: Germany
facility: Technical University of Munich
Study officials:
affiliation: University of Minnesota
name: Timothy R Church, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Epigenomics, Inc
name: Michael Wandell, PharmD.
role: STUDY_DIRECTOR
affiliation: University of North Carolina
name: David F Ransohoff, MD
role: STUDY_CHAIR
References:
citation: Payne SR, Church TR, Wandell M, Rosch T, Osborn N, Snover D, Day RW, Ransohoff DF, Rex DK. Endoscopic detection of proximal serrated lesions and pathologic identification of sessile serrated adenomas/polyps vary on the basis of center. Clin Gastroenterol Hepatol. 2014 Jul;12(7):1119-26. doi: 10.1016/j.cgh.2013.11.034. Epub 2013 Dec 10.
citation: Church TR, Wandell M, Lofton-Day C, Mongin SJ, Burger M, Payne SR, Castanos-Velez E, Blumenstein BA, Rosch T, Osborn N, Snover D, Day RW, Ransohoff DF; PRESEPT Clinical Study Steering Committee, Investigators and Study Team. Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer. Gut. 2014 Feb;63(2):317-25. doi: 10.1136/gutjnl-2012-304149. Epub 2013 Feb 13.