An Early Phase 1 interventional study of Blood Sample in Colorectal Cancer, sponsored by Epigenomics, Inc. Completed. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-04.
Sponsored by Epigenomics, Inc · Early Phase 1, Interventional, and Diagnostic
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 562 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Epigenomics, Inc is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Blood Sample
Blood sample collection
Effectiveness of the Epi proColon test
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.
Time frame: 12 months
No study locations are listed for this record.
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Epigenomics, Inc