Detection of Colorectal Cancer in Peripheral Blood by Septin 9 DNA Methylation Assay
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
1 other identifier
observational
700
2 countries
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2005
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 10, 2008
CompletedFirst Posted
Study publicly available on registry
June 12, 2008
CompletedJune 17, 2008
June 1, 2008
1.7 years
June 10, 2008
June 13, 2008
Conditions
Keywords
Study Arms (2)
1
Colorectal cancer patients, Stages I-IV
2
Non colorectal cancer patients, verified by colonoscopy
Eligibility Criteria
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.
You may qualify if:
- Group 1 diagnosis of colorectal cancer
You may not qualify if:
- Group 2 diagnosis of colorectal cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Epigenomics, Inclead
Study Sites (5)
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, 01307, Germany
Department of Surgery, University Hospital Schleswig-Holstein, Campus Lübeck
Lübeck, 23538, Germany
Völklingen Clinic
Völklingen, Germany
Semmelweis University
Budapest, Hungary
Biospecimen
Residual plasma samples retained according to protocol.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine Lofton-Day, PhD
Epigenomics, Inc
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 10, 2008
First Posted
June 12, 2008
Study Start
January 1, 2005
Primary Completion
October 1, 2006
Study Completion
February 1, 2007
Last Updated
June 17, 2008
Record last verified: 2008-06