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

50 Years
Not Enrolling
Colorectal Cancer

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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.

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

- 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)

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Clinical/surgical diagnosis of invasive colorectal adenocarcinoma detected by optical colonoscopy and confirmed by histology compared to the Septin 9 Biomarker classification.

Outcome Time Frame:

One Year

Safety Issue:


Principal Investigator

Timothy R Church, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Minnesota - Clinical and Translational Science Institute


United States: Institutional Review Board

Study ID:




Start Date:

June 2008

Completion Date:

April 2010

Related Keywords:

  • Colorectal Cancer
  • colorectal cancer
  • early detection
  • methylation, biomarker
  • Colorectal Neoplasms



Northwest Gastroenterology AssociatesBellevue, Washington  98004
University of LouisvilleLouisville, Kentucky  40202
Atlanta Gastroenterology AssociatesAtlanta, Georgia  
The Oregon ClinicPortland, Oregon  97213
Minnesota GastroenterologyPlymouth, Minnesota  55446
Northwest Gastroenterology ClinicPortland, Oregon  97210
Charlottesville Medical ResearchCharlottesville, Virginia  22911
Digestive CareBoca Raton, Florida  33486
GI Care CenterMiami, Florida  33173
Rockford Gastroenterology Associates, Ltd.Rockford, Illinois  61107
Heartland Medical Research, Inc.Clive, Iowa  50325
Jackson Gastrointestinal AssociatesJackson, Mississippi  39202
Asheville Gastroenterology Associates PAAsheville, North Carolina  28801
Southern Gastroenterology AssociatesNew Bern, North Carolina  28562
Digestive Health SpecialistsWinston-Salem, North Carolina  27103
The Portland ClinicPortland, Oregon  97205
Regional Gastroenterology Associates of Lancaster, Ltd.Lancaster, Pennsylvania  17604
Medical University of South Carolina Digestive Disease CenterCharleston, South Carolina  29425
Gastroenterology Center of the MidSouthGermantown, Tennessee  38138
Tacoma Digestive Disease Research CenterTacoma, Washington  98405