Specimens for Septin 9 Performance

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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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample

Other

Blood sample collection

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Epigenomics, Inc

Industry

Registry information

Official study title

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

Acronym: SPR0012

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Apr 6, 2011
Registry last updated: Aug 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed