NCT00720993Unknown不适用
Altered Gene Expression in Colorectal "Smears" of Individuals With Colon Cancer
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- - To select a threshold for Mahalanobis distance to determine the best operating characteristics (sensitivity and specificity) in subjects with cancer and subjects without cancer. - To explore other empirical metrics based on previous exploratory data
研究概览
简要总结
The purpose of this study is to evaluate the gene expression patterns from colorectal mucosal cells collected through the use of a standard anoscope and cytology brush. Patients will include those scheduled for routine colonoscopy procedures and those with confirmed colorectal cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •willing to provide informed consent
- •greater than or equal to 50 years of age
- •patient is scheduled for routine colonoscopy procedure or colorectal cancer surgery
- •subject is willing to provide colorectal mucosal sample for gene expression testing
排除标准
- •recent radiation or treatment for gynecologic, prostate or rectal cancer
- •recent surgery for anal rectal disease
- •polys, family or self history of cancer (control group only)
- •GI disease
- •any mucosal disease or systemic condition that may confound the scientific interpretation of the gene expression results
结局指标
主要结局
- To select a threshold for Mahalanobis distance to determine the best operating characteristics (sensitivity and specificity) in subjects with cancer and subjects without cancer. - To explore other empirical metrics based on previous exploratory data
时间窗: Mai 2009
次要结局
- - To obtain data to estimate sensitivity, specificity, and the ROC curve for a test based on M-distance. - To determine the variability of sensitivity and specificity estimates(Mai 2009)
研究者
研究点 (1)
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