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

NCT ID: NCT00696345

Last Updated: 2008-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Colorectal Cancer

Keywords

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colorectal cancer screening biomarker plasma blood

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Colorectal cancer patients, Stages I-IV

No interventions assigned to this group

2

Non colorectal cancer patients, verified by colonoscopy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Group 1 diagnosis of colorectal cancer

Exclusion Criteria

* Group 2 diagnosis of colorectal cancer
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Epigenomics, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Epigenomics

Principal Investigators

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Catherine Lofton-Day, PhD

Role: PRINCIPAL_INVESTIGATOR

Epigenomics, Inc

Locations

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Department of Surgery and Surgical Oncology, Charité Campus Berlin Buch

Berlin, , Germany

Site Status

Department of Visceral-, Thoracic- and Vascular Surgery, University Hospital Carl Gustav Carus

Dresden, , Germany

Site Status

Department of Surgery, University Hospital Schleswig-Holstein, Campus Lübeck

Lübeck, , Germany

Site Status

Völklingen Clinic

Völklingen, , Germany

Site Status

Semmelweis University

Budapest, , Hungary

Site Status

Countries

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Germany Hungary

Other Identifiers

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Septin-9-2006

Identifier Type: -

Identifier Source: org_study_id