Status:
COMPLETED
PRESEPT Study: Evaluation of SEPT9 Biomarker Performance for Colorectal Cancer Screening
Lead Sponsor:
Epigenomics, Inc
Conditions:
Colorectal Cancer
Eligibility:
All Genders
50+ years
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 evaluat...
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 mult...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
7929 Patients enrolled
Trial Details
Trial ID
NCT00855348
Start Date
June 1 2008
End Date
April 1 2010
Last Update
August 4 2014
Active Locations (23)
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1
Digestive Care
Boca Raton, Florida, United States, 33486
2
GI Care Center
Miami, Florida, United States, 33173
3
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30134
4
Rockford Gastroenterology Associates, Ltd.
Rockford, Illinois, United States, 61107