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Specimens for Septin 9 Performance (SPR0012)

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ClinicalTrials.gov Identifier: NCT01329718
Recruitment Status : Completed
First Posted : April 6, 2011
Last Update Posted : August 4, 2014
Sponsor:
Information provided by (Responsible Party):
Epigenomics, Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: Blood Sample Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 562 participants
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
Study Start Date : May 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: CRC Group Other: Blood Sample
Blood sample collection



Primary Outcome Measures :
  1. 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.



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

Responsible Party: Epigenomics, Inc
ClinicalTrials.gov Identifier: NCT01329718     History of Changes
Other Study ID Numbers: Epigenomics_SPR0012
First Posted: April 6, 2011    Key Record Dates
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
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