Specimens for Septin 9 Performance

Colorectal Cancer Clinical Trial

— SPR0012  

Official title:

Specimen Collection Protocol for the Performance Evaluation of the Septin 9 Assay

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01329718
• Other study ID #: Epigenomics_SPR0012
• Status: Completed
• Phase: Phase 0
• First received: April 4, 2011
• Last updated: August 1, 2014
• Start date: May 2011
• Est. completion date: December 2012

Study information

• Verified date: August 2014
• Source: Epigenomics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 562
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Other:
• Blood Sample
Blood sample collection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Epigenomics, Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months	No