Specimens for Septin 9 Performance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

562 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CRC Group

Group Type EXPERIMENTAL

Blood Sample

Intervention Type OTHER

Blood sample collection

Interventions

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Blood Sample

Blood sample collection

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes