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Specimens for Septin 9 Performance (SPR0012)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: April 6, 2011
Last Update Posted: August 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Epigenomics, Inc
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 Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Specimen Collection Protocol for the Performance Evaluation of the Septin 9 Assay

Further study details as provided by Epigenomics, Inc:

Primary Outcome Measures:
  • Effectiveness of the Epi proColon test [ Time Frame: 12 months ]
    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.

Enrollment: 562
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


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Responsible Party: Epigenomics, Inc
ClinicalTrials.gov Identifier: NCT01329718     History of Changes
Other Study ID Numbers: Epigenomics_SPR0012
First Submitted: April 4, 2011
First Posted: April 6, 2011
Last Update Posted: August 4, 2014
Last Verified: August 2014

Keywords provided by Epigenomics, Inc:
Stability of the Septin 9 biomarker
Epi Pro Colon Test

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases