PRESEPT Study: Evaluation of SEPT9 Biomarker Performance for Colorectal Cancer Screening
- Conditions
- Colorectal Cancer
- Interventions
- Other: All eligible subjects will provide blood for SEPT9 biomarker testing
- Registration Number
- NCT00855348
- Lead Sponsor
- Epigenomics, Inc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7929
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Adults > 50 Years Scheduled for Colonscopy All eligible subjects will provide blood for SEPT9 biomarker testing Average to increased risk adults older than 50 years without symptoms indicative of CRC and designated for colonoscopy.
- Primary Outcome Measures
Name Time Method Clinical/surgical diagnosis of invasive colorectal adenocarcinoma detected by optical colonoscopy and confirmed by histology compared to the Septin 9 Biomarker classification. One Year
- Secondary Outcome Measures
Name Time Method 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. One Year
Trial Locations
- Locations (23)
GI Care Center
🇺🇸Miami, Florida, United States
Digestive Care
🇺🇸Boca Raton, Florida, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
University of Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Technical University of Munich
🇩🇪Munich, Germany
Asheville Gastroenterology Associates PA
🇺🇸Asheville, North Carolina, United States
Southern Gastroenterology Associates
🇺🇸New Bern, North Carolina, United States
Gastroenterology Center of the MidSouth
🇺🇸Germantown, Tennessee, United States
Northwest Gastroenterology Associates
🇺🇸Bellevue, Washington, United States
Tacoma Digestive Disease Research Center
🇺🇸Tacoma, Washington, United States
Jackson Gastrointestinal Associates
🇺🇸Jackson, Mississippi, United States
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
Rockford Gastroenterology Associates, Ltd.
🇺🇸Rockford, Illinois, United States
Heartland Medical Research, Inc.
🇺🇸Clive, Iowa, United States
Regional Gastroenterology Associates of Lancaster, Ltd.
🇺🇸Lancaster, Pennsylvania, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Minnesota Gastroenterology
🇺🇸Minneapolis, Minnesota, United States
Digestive Health Specialists
🇺🇸Winston-Salem, North Carolina, United States
The Portland Clinic
🇺🇸Portland, Oregon, United States
Northwest Gastroenterology Clinic
🇺🇸Portland, Oregon, United States
The Oregon Clinic
🇺🇸Portland, Oregon, United States
Medical University of South Carolina Digestive Disease Center
🇺🇸Charleston, South Carolina, United States
Berlin Private-Practice Gastroenterology Working Group
🇩🇪Berlin, Germany