Specimens for Septin 9 Performance (SPR0012)
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.
|Study Design:||Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Specimen Collection Protocol for the Performance Evaluation of the Septin 9 Assay|
- 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.
|Study Start Date:||May 2011|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|