Specimen Collection Protocol for the Performance Evaluation of the Septin 9 Assay
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 562
- 主要终点
- Effectiveness of the Epi proColon test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Effectiveness of the Epi proColon test
时间窗: 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.
次要结局
未报告次要终点