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

Colorectal Cancer Clinical Trial

— PRESEPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00855348
• Other study ID #: Epigenomics_SPR0006
• Status: Completed
• Phase: N/A
• First received: February 4, 2009
• Last updated: August 1, 2014
• Start date: June 2008
• Est. completion date: April 2010

Study information

• Verified date: August 2014
• Source: Epigenomics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardGermany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7929
• Est. completion date: April 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Germany	Berlin Private-Practice Gastroenterology Working Group	Berlin
Germany	University of Hamburg-Eppendorf	Hamburg
Germany	Technical University of Munich	Munich
United States	Asheville Gastroenterology Associates PA	Asheville	North Carolina
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Northwest Gastroenterology Associates	Bellevue	Washington
United States	Digestive Care	Boca Raton	Florida
United States	Medical University of South Carolina Digestive Disease Center	Charleston	South Carolina
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	Heartland Medical Research, Inc.	Clive	Iowa
United States	Gastroenterology Center of the MidSouth	Germantown	Tennessee
United States	Jackson Gastrointestinal Associates	Jackson	Mississippi
United States	Regional Gastroenterology Associates of Lancaster, Ltd.	Lancaster	Pennsylvania
United States	University of Louisville	Louisville	Kentucky
United States	GI Care Center	Miami	Florida
United States	Minnesota Gastroenterology	Minneapolis	Minnesota
United States	Southern Gastroenterology Associates	New Bern	North Carolina
United States	Northwest Gastroenterology Clinic	Portland	Oregon
United States	The Oregon Clinic	Portland	Oregon
United States	The Portland Clinic	Portland	Oregon
United States	Rockford Gastroenterology Associates, Ltd.	Rockford	Illinois
United States	Tacoma Digestive Disease Research Center	Tacoma	Washington
United States	Digestive Health Specialists	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Epigenomics, Inc

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical/surgical diagnosis of invasive colorectal adenocarcinoma detected by optical colonoscopy and confirmed by histology compared to the Septin 9 Biomarker classification.		One Year	No
Secondary	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.		One Year	No