Comparing the Diagnostic Value of Different Lymph Node Tracing Methods in Detecting Sentinel Lymph Node Metastasis in Early Cervical Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 1,143
- 试验地点
- 1
- 主要终点
- Negative Predictive Value
研究概览
简要总结
Lymph node assessment provides the crucial information about the prognosis of cervical cancer. Sentinel lymph node stands in the first station on the lymph node metastasis pathways. While traditional systemically lymph node resection would bring a lot of complications, sentinel node mapping and biopsy is a feasible way with less damage to evaluate whether lymph node metastasis occurs in early cervical cancer patients, due to less lymph nodes resected. However, the process of this technology isn't well established. The investigators intend to conduct a prospective and multicentric study to evaluate the effectiveness of different mapping methods to achieve a reliable lymph node assessment. Early cervical cancer patients in each center will be recruited in the investigators' study with inclusion and exclusion criteria. After the patients signing the informed consent form, the surgery process will be performed, including sentinel lymph node mapping with Carbon Nanoparticles (CNP) or CNP combining Indocyanine Green(ICG), extra-fascial/sub-extensive/extensive hysterectomy, pelvic with or without para-aortic lymph node resection, sequentially. All resected nodes will be pathologically exanimated. Then the data obtained will be analyzed and discussed deeply and finally lead to a conclusion.
详细描述
Quality Control The investigators' quality assurance plan is as follows： A. Once the plan has been approved, it cannot be modified at will. If special circumstances such as difficulty in implementation are found after the start of the study, the proposal may be revised or supplemented by the discussion of the research group and the project leader, and the revised content shall be recorded in writing.
The program change process is as follows:
- Identify the problems and understand the necessary to change the plan;
- Convene the main members of the research team and the project leader to discuss and propose solutions;
- Revise the plan and update the version number, fill out the "Program Description";
- The revised plan and the "Revision of the Plan" need to be signed by the person in charge of the project. If necessary, they must be submitted to the ethics committee for approval or filing; if approved, the revised plan can be implemented.
B. In order to ensure that the research personnel have sufficient qualifications to undertake specific research work, the research personnel should at least complete the following training before the project starts:
- Research object protection and ethical requirements;
- Study protocols and related standard operating procedures (tracer injection methods, use of near-infrared fluorescent vascular imagers, and pathology);
- Case Report Form and gauge filling instructions (form entry criteria, surgical record methods, etc.);
- Clinical research project implementation considerations (such as research object screening, enrollment, data collection process); Project-related training should be carried out throughout the research process. The project leader and project coordinator can increase the training content according to the situation, such as training on weak links in the test, training on updating programs and various causes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of early cervical cancer (FIGO IA1 with LVSI (+) to IIA).
- •Decide to receive extra-fascial/sub-extensive/extensive hysterectomy, pelvic with or without aortic lymph node resection
- •Agree to conduct the study and sign an informed consent form
排除标准
- •Diagnosis of cervical cancer in FIGO IIB stage and above
- •History of previous pelvic or inguinal lymphadenectomy or other history of surgery affecting the uterine lymphatic drainage
- •Other history of pelvic or abdominal malignant tumors in the past 5 years
- •Intolerable for surgery due to severe comorbidities
- •During a period of pregnancy
- •Allergic to the tracer
- •Diagnosis of uncontrolled epilepsy, central nervous system disease or mental disorder, with the judgment from the investigator that the above diseases would affect clinical research compliance.
研究组 & 干预措施
Undergoing sentinel lymph node biopsy
This group of patients will undergo sentinel lymph node biopsy.
干预措施: sentinel lymph node biopsy (Procedure)
结局指标
主要结局
Negative Predictive Value
时间窗: Through study completion, an average of 2 years
Sentinel lymph node detection is defined as at least one lymph node is found in a patient. Sentinel lymph node negative is defined as no sentinel lymph node detected. True negative is defined as no metastasis found in both sentinel lymph nodes (SLNs) and non-SLNs. Negative predictive value is defined as the proportion of true negative patients to SLNs negative patients in patients with sentinel lymph nodes detected, which means patients without SLNs detected won't be included in the calculation.
次要结局
- Sensitivity(Through study completion, an average of 2 years)
- SLNs detection rate(Through study completion, an average of 2 years)
- False negative rate(Through study completion, an average of 2 years)