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

This study has been completed.
Sponsor:
Information provided by:
Epigenomics, Inc
ClinicalTrials.gov Identifier:
NCT00855348
First received: February 4, 2009
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

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 Intervention
Colorectal Cancer
Other: All eligible subjects will provide blood for SEPT9 biomarker testing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PRESEPT Study: Prospective Evaluation of Septin 9 Performance for Colorectal Cancer Screening

Resource links provided by NLM:


Further study details as provided by Epigenomics, Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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.


Enrollment: 7929
Study Start Date: June 2008
Study Completion Date: April 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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.

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855348

  Show 23 Study Locations
Sponsors and Collaborators
Epigenomics, Inc
Investigators
Principal Investigator: Timothy R Church, Ph.D. University of Minnesota - Clinical and Translational Science Institute
Study Director: Michael Wandell, PharmD. Epigenomics, Inc
Study Chair: David F Ransohoff, MD University of North Carolina
  More Information

No publications provided by Epigenomics, Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Timothy R. Church, Ph.D., University of Minnesota School of Public Health
ClinicalTrials.gov Identifier: NCT00855348     History of Changes
Other Study ID Numbers: Epigenomics_SPR0006
Study First Received: February 4, 2009
Last Updated: August 1, 2014
Health Authority: United States: Institutional Review Board
Germany: Ethics Commission

Keywords provided by Epigenomics, Inc:
colorectal cancer
early detection
methylation, biomarker

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Troclosene
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Disinfectants

ClinicalTrials.gov processed this record on August 27, 2014