NCT00826579已完成1 期
Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer
University Hospital, Basel, Switzerland6 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2000年5月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 6
- 主要终点
- To assess the extent of upstaging due to the SLN procedure for colon cancer.
研究概览
简要总结
The study is a feasibility and validation study of the sentinel lymph node (SLN) procedure in all stages of colon cancer. If the SLN can be reliably identified, it could be submitted to a more accurate histopathological examination (multiple sections, special staining). The detection of micrometastases in the SLN (occult stage III, upstaging) is possible. Patients with micrometastases should be considered at higher risk.
Additionally, a search for occult metastatic tumor cells in the bone marrow is performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colon cancer at any stage diagnosed histologically or high degree of suspicion for colon cancer at endoscopy, which cannot be confirmed with certainty in the biopsy. The diagnosis of cancer must be certain in the definitive histology.
- •Possibility of transabdominal injection of the dye (cancers below the peritoneal reflection in which the injection of dye must be carried out through rectoscopy, are therefore excluded).
- •Patient's informed consent
排除标准
- •Prior intrabdominal tumor surgery
- •Other preexisting malignancies
- •Hypersensitivity/allergy to dye (isosulfan blue)
- •Pregnancy
- •Breast-feeding
- •No patient's informed consent
结局指标
主要结局
To assess the extent of upstaging due to the SLN procedure for colon cancer.
时间窗: 1 month
次要结局
- To evaluate the accuracy of the SLN procedure for colon cancer. To identify factors influencing the success of the procedure. To correlate SLN results with the presence of colon cancer cell in bone marrow aspirates. To assess OS and DFS.(1 month, 3 and 5 years after surgery)
研究者
研究点 (6)
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