Ex-vivo Sentinel Lymph Node in Stage I-II Colon Cancer: Kappa Analysis With Immunochemistry and Molecular Biology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Concordance between immunochemistry and molecular biology
研究概览
简要总结
Unmask Trial aims to evaluate the Kappa concordance between immunochemistry and molecular biology to detecting cancer cells in sentinel lymph node in patients undergoing colectomy for non metastatic colon cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colectomy for Non metastatic colon cancer
排除标准
- •No medical insurance
- •Pregnant woman
- •Psychiatric disorders
结局指标
主要结局
Concordance between immunochemistry and molecular biology
时间窗: 1 month
The primary outcome is the rate of concordance between the number of positive sentinel lymph nodes detected by immunochemistry using an anti-cytokeratin antibody (KL1) and molecular biology targeting CK20 on tumoral RNA after RT-PCR. The rate of positivity of the sentinel lymph nodes will be then compared to the standard technique using HES coloration used in routine pathological examination. Only the result using the routine examination will be used to decide whether the patient should benefit from an adjuvant chemotherapy.
次要结局
- Disease-free survival(3 years)
研究者
Zaher Lakkis
MD
Centre Hospitalier Universitaire de Besancon