Specimens for Septin 9 Performance (SPR0012)

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014