Specimens for Septin 9 Performance (SPR0012)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Blood Sample
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Stability of the Septin 9 biomarker, Epi Pro Colon Test, CRC
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CRC Group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01329718
Brief Title
Specimens for Septin 9 Performance
Acronym
SPR0012
Official Title
Specimen Collection Protocol for the Performance Evaluation of the Septin 9 Assay
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Epigenomics, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Stability of the Septin 9 biomarker, Epi Pro Colon Test, CRC
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Enrollment
562 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CRC Group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Blood Sample
Intervention Description
Blood sample collection
Primary Outcome Measure Information:
Title
Effectiveness of the Epi proColon test
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
Specimens for Septin 9 Performance
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