Detection of Cancer Cells and Tumor Margins During Colorectal Cancer Surgery by Intraoperative Flow Cytometry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Accuracy of intraoperative Flow Cytometry for cancer cell identification in colorectal cancer.
研究概览
简要总结
This study was designed to investigate the efficacy of flow cytometry to accurately identify between normal and cancer cells in colon epithelium in humans diagnosed with colorectal cancer.
详细描述
Tissue samples from normal and cancerous colon epithelium are collected intraoperatively following standard colectomy and analyzed blindly by flow cytometry, which reports, in less than 10 min, on the origin of the sample based in the estimation of DNA and tumor index.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •biopsy proven colorectal cancer signed informed consent for participation
排除标准
- 未提供
结局指标
主要结局
Accuracy of intraoperative Flow Cytometry for cancer cell identification in colorectal cancer.
时间窗: 2017-2021
Samples from cancer and normal colon epithelium are prospectively collected intraoperatively and assessed with intraoperative Flow Cytometry. Following comparative DNA content and phenotypic analysis, the receiver operating characteristic (ROC) curve analysis is used to evaluate the performance of intraoperative Flow Cytometry to distinguish between normal and cancer tissue. The optimal cut-off value is determined to delineate the status of tumor tissue, resulting in the highest sensitivity and specificity and hence the optimal accuracy.
次要结局
未报告次要终点
研究者
CHRISTINA BALI
ACCOSIATE PROFESOR OF SURGERY
University Hospital, Ioannina