Specimens for Septin 9 Performance (SPR0012)
This study has been completed.
Sponsor:
Epigenomics, Inc
Information provided by (Responsible Party):
Epigenomics, Inc
ClinicalTrials.gov Identifier:
NCT01329718
First received: April 4, 2011
Last updated: February 6, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Other: Blood Sample |
Phase 0 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Epigenomics, Inc:
Primary Outcome Measures:
- 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.
| Estimated Enrollment: | 600 |
| Study Start Date: | May 2011 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: CRC Group |
Other: Blood Sample
Blood sample collection
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Epigenomics, Inc |
| ClinicalTrials.gov Identifier: | NCT01329718 History of Changes |
| Other Study ID Numbers: | Epigenomics_SPR0012 |
| Study First Received: | April 4, 2011 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Epigenomics, Inc:
|
Stability of the Septin 9 biomarker Epi Pro Colon Test CRC |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013