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Specimens for Septin 9 Performance (SPR0012)

This study has been completed.
Information provided by (Responsible Party):
Epigenomics, Inc Identifier:
First received: April 4, 2011
Last updated: August 1, 2014
Last verified: August 2014

April 4, 2011
August 1, 2014
May 2011
December 2012   (final data collection date for primary outcome measure)
Effectiveness of the Epi proColon test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The primary objective of the investigation is to determine the safety and effectiveness of the Epi proColon test in precision and reproducibility studies and varying conditions including interfering substances and co-morbidities associated with the testing population. The specimens collected as described in this protocol will be used in the experiments needed to achieve this objective. Validate the Stability of the Septin 9 Biomarker.
Same as current
Complete list of historical versions of study NCT01329718 on Archive Site
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Specimens for Septin 9 Performance
Specimen Collection Protocol for the Performance Evaluation of the Septin 9 Assay

Epigenomics has identified methylated gene regions that are specific for colorectal cancer (CRC). Through Epigenomics' marker discovery and validation process Septin 9 was identified as a particularly robust methylation marker for detection of CRC. Epigenomics is currently developing a blood based CRC screening test based on Septin 9 and is performing a large prospective clinical trial showing its clinical utility in a population at average risk for CRC. Parallel to this trial further activities are needed to evaluate, optimize, and develop pre-analytical and analytical workflows as well as molecular assays making possible the use of Septin 9 methylation in the clinical routine.

Not Provided
Phase 0
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Colorectal Cancer
Other: Blood Sample
Blood sample collection
Experimental: CRC Group
Intervention: Other: Blood Sample
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 50 years of age or older at the time of the blood draw
  • Histologically confirmed or strong clinical suspicion of adenocarcinoma of the colon or rectum
  • CRC defined as invasive adenocarcinoma

Exclusion Criteria:

  • Previous personal history of colorectal cancer
  • Any cancer specific treatment (e.g. polypectomy, chemotherapy, radiation, or surgery) prior to blood draw, including neoadjuvant treatment
  • Known infection with HIV, HBV or HCV
  • Subject concurrently receiving intravenous fluid at the time of the specimen collection
50 Years and older
Contact information is only displayed when the study is recruiting subjects
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Epigenomics, Inc
Epigenomics, Inc
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Epigenomics, Inc
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP