Specimens for Septin 9 Performance

Early Phase 1

Completed

• Conditions: Colorectal Cancer
• Interventions: Other: Blood Sample

• Registration Number: NCT01329718
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-04
• Study First Submitted QC: 2011-04-05
• Study First Posted: 2011-04-06
• Study Start: 2011-05
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-01
• Last Update Posted: 2014-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 562

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CRC Group	Blood Sample	-

Primary Outcome Measures

Name	Time	Method
Effectiveness of the Epi proColon test	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.