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

This study has been completed.
Sponsor:
Information provided by:
Epigenomics, Inc
ClinicalTrials.gov Identifier:
NCT00696345
First received: June 10, 2008
Last updated: June 13, 2008
Last verified: June 2008
  Purpose

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
Colorectal Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Epigenomics, Inc:

Biospecimen Retention:   Samples With DNA

Residual plasma samples retained according to protocol.


Enrollment: 700
Study Start Date: January 2005
Study Completion Date: February 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Colorectal cancer patients, Stages I-IV
2
Non colorectal cancer patients, verified by colonoscopy

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

  • Group 1 diagnosis of colorectal cancer

Exclusion Criteria:

  • Group 2 diagnosis of colorectal cancer
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00696345

Locations
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, 01307
Department of Surgery, University Hospital Schleswig-Holstein, Campus Lübeck
Lübeck, Germany, 23538
Völklingen Clinic
Völklingen, Germany
Hungary
Semmelweis University
Budapest, Hungary
Sponsors and Collaborators
Epigenomics, Inc
Investigators
Principal Investigator: Catherine Lofton-Day, PhD Epigenomics, Inc
  More Information

No publications provided

Responsible Party: Michael Wandell VP Clinical, Regulatory, Quality, Epigenomics
ClinicalTrials.gov Identifier: NCT00696345     History of Changes
Other Study ID Numbers: Septin-9-2006
Study First Received: June 10, 2008
Last Updated: June 13, 2008
Health Authority: United States: Institutional Review Board
Germany: Ethics Commission

Keywords provided by Epigenomics, Inc:
colorectal cancer
screening
biomarker
plasma
blood

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 20, 2014