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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00696345
Recruitment Status : Completed
First Posted : June 12, 2008
Last Update Posted : June 17, 2008
Information provided by:
Epigenomics, Inc

Brief 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.

Condition or disease
Colorectal Cancer

Detailed 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.

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Study Type : Observational
Actual Enrollment : 700 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Study Start Date : January 2005
Actual Primary Completion Date : October 2006
Actual Study Completion Date : February 2007

Colorectal cancer patients, Stages I-IV
Non colorectal cancer patients, verified by colonoscopy

Biospecimen Retention:   Samples With DNA
Residual plasma samples retained according to protocol.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects are identified at colonoscopy as having or not having colorectal cancer. Blood from all subjects was drawn either before or more than 2 days and up to 6 months after colonoscopy and prior to starting any cancer specific treatment. Cancer diagnosis was confirmed histologically from the surgical specimen and only adenocarcinomas were included in this study.

Inclusion Criteria:

  • Group 1 diagnosis of colorectal cancer

Exclusion Criteria:

  • Group 2 diagnosis of colorectal cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00696345

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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, 01307
Department of Surgery, University Hospital Schleswig-Holstein, Campus Lübeck
Lübeck, Germany, 23538
Völklingen Clinic
Völklingen, Germany
Semmelweis University
Budapest, Hungary
Sponsors and Collaborators
Epigenomics, Inc
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Principal Investigator: Catherine Lofton-Day, PhD Epigenomics, Inc
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Responsible Party: Michael Wandell VP Clinical, Regulatory, Quality, Epigenomics Identifier: NCT00696345    
Other Study ID Numbers: Septin-9-2006
First Posted: June 12, 2008    Key Record Dates
Last Update Posted: June 17, 2008
Last Verified: June 2008
Keywords provided by Epigenomics, Inc:
colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases