NCT03779009招募中不适用
Minimally INvasive Colon Cancer Surgery Through IMmunomics and Optical Mapping of the Sentinel Lymph Node.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Tumor status of the sentinel lymph node (SLN) and other lymph nodes (LN's)
研究概览
简要总结
The project investigates the feasibility of laparoscopic fluorescent imaging for the intraoperative detection of the sentinel lymph node (SLN) in colon cancer patients. In addition, the topology of immunological and microenvironmental changes in normal and invaded lymph nodes (LN's) will be correlated to the LN location (anatomical mapping).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Tumor type: proven adenocarcinoma of the colon
- •Extent of disease (AJCC 7th edition): clinically node negative (stage II) non-metastatic colon cancer
- •Locally resectable disease
- •Adequate mental faculty, allowing to understand the proposed treatment protocol and provide informed consent
- •Laboratory data
- •Serum creatinine ≤ 1.5 mg/dl or a calculated GFR ≥ 60 mL/min/1.73 m2
- •Serum total bilirubin ≤ 1.5 mg/dl, except for known Gilbert's disease
- •Platelet count > 100,000/µl
- •Hemoglobin > 9g/dl
- •Neutrophil granulocytes > 1,500/ml
- •International Normalized Ratio (INR) ≤ 2
- •Absence of alcohol and/or drug abuse
- •No inclusion in other clinical trials interfering with the study protocol
- •No concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy
- •Absence of any severe organ insufficiency
- •No pregnancy or breast feeding
- •Adequate contraception in fertile patients
- •Written informed consent
排除标准
- •Node positive and/or metastatic disease
- •Locally unresectable disease
- •Medically unfit patients (Karnofsky index < 70%)
- •Allergies to any of the procedural substances (allergy to iodides, hypersensitivity to products containing human albumin)
结局指标
主要结局
Tumor status of the sentinel lymph node (SLN) and other lymph nodes (LN's)
时间窗: up to 1 month after surgery
All LN in the resection specimen will be collected, mapped, and labeled. The SLN is defined as fluorescent hotspot that appears after injection of the tracer. Standard H\&E staining will be performed on LN sections and all mapped LN (including the SLN) will be analyzed for their tumor status.
次要结局
- Immunological markers(up to 12 months after surgery)
研究者
研究点 (2)
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