Specimens for Septin 9 Performance
SPR0012
Specimen Collection Protocol for the Performance Evaluation of the Septin 9 Assay
1 other identifier
interventional
562
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1 colorectal-cancer
Started May 2011
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2011
CompletedFirst Posted
Study publicly available on registry
April 6, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedAugust 4, 2014
August 1, 2014
1.6 years
April 4, 2011
August 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
CRC Group
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Epigenomics, Inclead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2011
First Posted
April 6, 2011
Study Start
May 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
August 4, 2014
Record last verified: 2014-08