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Sponsored by: |
Epigenomics, Inc |
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Information provided by: | Epigenomics, Inc |
ClinicalTrials.gov Identifier: | NCT00855348 |
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 |
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Colorectal Cancer |
Other: All eligible subjects will provide blood for SEPT9 biomarker testing |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | PRESEPT Study: Prospective Evaluation of Septin 9 Performance for Colorectal Cancer Screening |
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.
Estimated Enrollment: | 7500 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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Adults > 50 Years Scheduled for Colonscopy
Average to increased risk adults older than 50 years without symptoms indicative of CRC and designated for colonoscopy.
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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.
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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.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
The study will be conducted in Subjects scheduled for screening colonoscopy according to current U.S. CRC screening guidelines.
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael Wandell, PharmD. | 206-883- 2918 | michael.wandell@epigenomics.com |
Contact: Catherine Lofton-Day, Ph.D. | 206-883-2913 | catherine.lofton-day@epigenomics.com |
Principal Investigator: | Timothy R Church, Ph.D. | University of Minnesota School of Public Health |
Study Director: | Michael Wandell, PharmD. | Epigenomics, Inc |
Study Chair: | David F Ransohoff, MD | University of North Carolina |
Responsible Party: | University of Minnesota School of Public Health ( Timothy R. Church, Ph.D. ) |
Study ID Numbers: | Epigenomics_SPR0006 |
Study First Received: | February 4, 2009 |
Last Updated: | September 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00855348 History of Changes |
Health Authority: | United States: Institutional Review Board; Germany: Ethics Commission |
colorectal cancer early detection methylation, biomarker |
Digestive System Diseases Digestive System Neoplasms Troclosene Gastrointestinal Diseases Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |