Detection of Colorectal Cancer in Peripheral Blood by Septin 9 DNA Methylation Assay

Colorectal Cancer Clinical Trial

Official title:

Feasibility Study for Performance of Septin 9 in Plasma From Cases With Colorectal Cancer and Controls With Non-Diseased, Non-Colorectal Disease and Non-Colorectal Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00696345
• Other study ID #: Septin-9-2006
• Status: Completed
• Phase: N/A
• First received: June 10, 2008
• Last updated: June 13, 2008
• Start date: January 2005
• Est. completion date: February 2007

Study information

• Verified date: June 2008
• 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

Epigenomics is developing a colon cancer screening assay based on differential methylation of specific CpG sites for the detection of early stage disease. A genome-wide methylation analysis and oligonucleotide array study using DNA from various stages of colon cancer and normal tissue have been completed to obtain candidate CpG markers. Based on results obtained in the above studies, Epigenomics has moved to the final stages of feasibility with a specific, highly sensitive real-time marker assay that is able to detect colon cancer DNA in blood plasma.

Description:

From public health as well as health economics perspectives, the poor adoption of current screening options limits the effectiveness of CRC screening initiatives; as stated by Sidney Winawer, MD, "the best test is the one that gets done." Current CRC screening guidelines include FOBT, sigmoidoscopy (alone or with FOBT), or colonoscopy. Non-invasive screening is conducted using FOBT, which while inexpensive, exhibits a low compliance rate (around 16% in the US) due to its use restrictions, perceived inconvenience and lack of consumer acceptance. The gold standard procedure for CRC detection is colonoscopy; it exhibits excellent performance characteristics, but has a limited utility as a first line screen due to its high cost, healthcare delivery resource limitations, and inadequate patient acceptance. It is believed a noninvasive, first-line screening assay capable of detecting individuals with colorectal disease, confirmed by colonoscopy, would have greater utility for population screening.

Epigenomics has identified methylated gene regions that are specific for colorectal cancer or pre-malignant tissue. Aberrantly methylated genes represent attractive candidate markers for cancer screening, as cancer-specific methylation changes occur early in tumorigenesis, appear to be stable, yield a positive amplifiable signal, and can be assayed with high analytical sensitivity. Since methylation occurs early and in distinct genomic areas, it is possible to achieve high clinical sensitivity with a small number of methylated DNA markers. Studies have shown that aberrantly methylated DNA markers can be detected in tissue and body fluids and are highly correlated to colorectal cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: February 2007
• Est. primary completion date: October 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Group 1 diagnosis of colorectal cancer

Exclusion Criteria:

• Group 2 diagnosis of colorectal cancer

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Germany	Department of Surgery and Surgical Oncology, Charité Campus Berlin Buch	Berlin
Germany	Department of Visceral-, Thoracic- and Vascular Surgery, University Hospital Carl Gustav Carus	Dresden
Germany	Department of Surgery, University Hospital Schleswig-Holstein, Campus Lübeck	Lübeck
Germany	Völklingen Clinic	Völklingen
Hungary	Semmelweis University	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Epigenomics, Inc

Countries where clinical trial is conducted

Germany,  Hungary,