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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: | August 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 colorectal cancer and designated for colonoscopy.
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Other: All eligible subjects will provide blood for SEPT9 biomarker testing
A single blood sample for each participant 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 |
United States, Florida | |
Digestive Care | Recruiting |
Boca Raton, Florida, United States, 33486 | |
Contact: Lisa Zwick 561-395-2424 | |
Principal Investigator: Andrew Zwick, MD | |
GI Care Center | Recruiting |
Miami, Florida, United States, 33173 | |
Contact: Jackie Casanova 305-913-0666 | |
Principal Investigator: James Leavitt, MD | |
United States, Georgia | |
Atlanta Gastroenterology Associates | Recruiting |
Atlanta, Georgia, United States, 30134 | |
Contact: Lakshmi Peddareddy lakshmi.peddareddy@atlantagastro.com | |
Principal Investigator: Neal Osborn, MD | |
United States, Illinois | |
Rockford Gastroenterology Associates, Ltd. | Recruiting |
Rockford, Illinois, United States, 61107 | |
Contact: Kathy Geissler KathyG@rockfordgi.com | |
Principal Investigator: Robert Barclay, MD | |
United States, Iowa | |
Heartland Medical Research, Inc. | Recruiting |
Clive, Iowa, United States, 50325 | |
Contact: Kim Naberhaus 515-223-4823 ext 323 | |
Principal Investigator: Harvey A. Giller, M.D. | |
United States, Kentucky | |
University of Louisville | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Contact: Rhonda Simpson rgsimp01@gwise.louisville.edu | |
Principal Investigator: John Wo, MD | |
United States, Minnesota | |
Minnesota Gastroenterology | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Jill Cordes jec@cccs.umn.edu | |
Principal Investigator: Timothy Church, Ph.D | |
Sub-Investigator: John Allen, MD | |
United States, North Carolina | |
Asheville Gastroenterology Associates PA | Recruiting |
Asheville, North Carolina, United States, 28801 | |
Contact: Roberta Golden 828-254-0881 | |
Principal Investigator: William Harlan, MD | |
Digestive Health Specialists | Recruiting |
Winston-Salem, North Carolina, United States, 27103 | |
Contact: Stephanie Riggs stephanier@digestivehealth.ws | |
Principal Investigator: William C. Bray, M.D. | |
United States, Oregon | |
Northwest Gastroenterology Clinic | Recruiting |
Portland, Oregon, United States, 97210 | |
Contact: Joann Baldwin jbaldwin@nwgastro.net | |
Principal Investigator: Roland W Bennetts, M.D. | |
The Portland Clinic | Recruiting |
Portland, Oregon, United States, 97205 | |
Contact: Susan Stindt sstindt@tpcllp.com | |
Principal Investigator: Burton Lazar, M.D. | |
United States, Pennsylvania | |
Regional Gastroenterology Associates of Lancaster, Ltd. | Recruiting |
Lancaster, Pennsylvania, United States, 17604 | |
Contact: Lani Coelho coelho@rgal.com | |
Principal Investigator: Raymond Foley, M.D. | |
United States, South Carolina | |
Medical University of South Carolina Digestive Disease Center | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Contact: Kyle Orrell orrell@musc.edu | |
Principal Investigator: Joseph Romagnuolo, M.D. | |
United States, Tennessee | |
Gastroenterology Center of the MidSouth | Recruiting |
Germantown, Tennessee, United States, 38138 | |
Contact: Kathy Wilson kathyw@gicentermidsouth.com | |
Principal Investigator: Ziad Younes, M.D. | |
United States, Virginia | |
Charlottesville Medical Research | Recruiting |
Charlottesville, Virginia, United States, 22911 | |
Contact: Nancy Bolton 434-817-2442 | |
Principal Investigator: Dan Pambianco, MD | |
United States, Washington | |
Northwest Gastroenterology Associates | Recruiting |
Bellevue, Washington, United States, 98008 | |
Contact: Bari Dorward bari@nwgastroassoc.com | |
Principal Investigator: Robert Wohlman, M.D. | |
Tacoma Digestive Disease Research Center | Recruiting |
Tacoma, Washington, United States, 98405 | |
Contact: Michelle Haggerty 253-272-8664 | |
Principal Investigator: William Hirota, M.D. | |
Germany | |
Berlin Private-Practice Gastroenterology Working Group | Recruiting |
Berlin, Germany | |
Contact: Thomas Rösch t.roesch@uke.de | |
Principal Investigator: Thomas Rösch, MD | |
Sub-Investigator: Jens Aschenbeck, MD | |
Sub-Investigator: Alireza Aminalai, MD | |
Sub-Investigator: Andreas Schroeder, MD | |
Sub-Investigator: Michael Mayr, MD |
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: | March 2, 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 |