Specimen Collection Protocol for the Performance Evaluation of the Septin 9 Assay
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Epigenomics, Inc
- Enrollment
- 562
- Primary Endpoint
- Effectiveness of the Epi proColon test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported