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

Sponsor

Epigenomics, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00696345

Collaborator

(none)

700

Enrollment

Locations

Duration (Months)

140

Patients Per Site

5.6

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

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 :

Jan 1, 2005

Actual Primary Completion Date :

Oct 1, 2006

Actual Study Completion Date :

Feb 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
1 Colorectal cancer patients, Stages I-IV
2 Non colorectal cancer patients, verified by colonoscopy

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Group 1 diagnosis of colorectal cancer

Exclusion Criteria:

Group 2 diagnosis of colorectal cancer

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Department of Surgery and Surgical Oncology, Charité Campus Berlin Buch	Berlin	Germany
2	Department of Visceral-, Thoracic- and Vascular Surgery, University Hospital Carl Gustav Carus	Dresden	Germany	01307
3	Department of Surgery, University Hospital Schleswig-Holstein, Campus Lübeck	Lübeck	Germany	23538
4	Völklingen Clinic	Völklingen	Germany
5	Semmelweis University	Budapest	Hungary