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PRESEPT Study: Evaluation of SEPT9 Biomarker Performance for Colorectal Cancer Screening (PRESEPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00855348
Recruitment Status : Completed
First Posted : March 4, 2009
Last Update Posted : August 4, 2014
Information provided by:
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.

Condition or disease Intervention/treatment
Colorectal Cancer Other: All eligible subjects will provide blood for SEPT9 biomarker testing

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.

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Study Type : Observational
Actual Enrollment : 7929 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PRESEPT Study: Prospective Evaluation of Septin 9 Performance for Colorectal Cancer Screening
Study Start Date : June 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Group/Cohort Intervention/treatment
Adults > 50 Years Scheduled for Colonscopy
Average to increased risk adults older than 50 years without symptoms indicative of CRC and designated for colonoscopy.
Other: All eligible subjects will provide blood for SEPT9 biomarker testing
A single blood sample per participant selected according to analysis plan is tested for evidence of methylation of a specific DNA sequence, SEPT9.
Other Names:
  • biomarker
  • blood
  • colorectal cancer
  • DNA methylation

Primary Outcome Measures :
  1. Clinical/surgical diagnosis of invasive colorectal adenocarcinoma detected by optical colonoscopy and confirmed by histology compared to the Septin 9 Biomarker classification. [ Time Frame: One Year ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: One Year ]

Biospecimen Retention:   Samples With DNA
Eligible consented Subjects meeting inclusion / exclusion criteria will have 40 ml of blood drawn prior to undergoing bowel cleansing in preparation for screening colonoscopy. Subject blood specimens will be processed according to Epigenomics' plasma preparation procedure (Blood Collection and Plasma Preparation SOP.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00855348

Show Show 23 study locations
Sponsors and Collaborators
Epigenomics, Inc
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Principal Investigator: Timothy R Church, Ph.D. University of Minnesota
Study Director: Michael Wandell, PharmD. Epigenomics, Inc
Study Chair: David F Ransohoff, MD University of North Carolina
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Timothy R. Church, Ph.D., University of Minnesota School of Public Health Identifier: NCT00855348    
Other Study ID Numbers: Epigenomics_SPR0006
First Posted: March 4, 2009    Key Record Dates
Last Update Posted: August 4, 2014
Last Verified: August 2014
Keywords provided by Epigenomics, Inc:
colorectal cancer
early detection
methylation, biomarker
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases