Trials / Completed
CompletedNCT01329718
Specimens for Septin 9 Performance
Specimen Collection Protocol for the Performance Evaluation of the Septin 9 Assay
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 562 (actual)
- Sponsor
- Epigenomics, Inc · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Blood Sample | Blood sample collection |
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2012-12-01
- Completion
- 2012-12-01
- First posted
- 2011-04-06
- Last updated
- 2014-08-04
Source: ClinicalTrials.gov record NCT01329718. Inclusion in this directory is not an endorsement.