Ultrasound Morphometric and Cyto/Histological Combined Pre-operative Assessment of Inguinal Lymph Node Status in Women With Invasive Vulvar Carcinoma
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Accuracy, negative predictive value (NPV) and positive predictive value (PPV) of fine needle aspiration in the prediction of groin lymph node status
研究概览
简要总结
Vulvar cancer is a rare and very aggressive cancer, mainly spreading through lymphatics, in which the preoperative evaluation is critical to address surgery between sentinel node biopsy or radical groin lymphadenectomy.
详细描述
In the absence of clearly an specific guidelines on preoperative vulvar cancer assessment, the investigators decided to better investigate the role of ultrasound in groin nodes evaluation through the study 10 sonographic features of suspicion for nodal involvement:
- globular shape (loss of the normal elliptical form)
- long/short axis ratio
- cortical/medulla ratio
- cortical focal bulging or thickening
- hilum anomalies
- inhomogeneous echostructure
- intranodal deposits
- extracapsular spread
- grouping
- vascularization
The standard of comparison is histopathology.
The prospectively evaluation of these parameters will be obtained on the enrolled patients.
The investigators also provided the retrospective review - by specialized staff - of ultrasound images collected in archives associated with information relating to the cyto/histological procedures (performed in case of suspicious lymph nodes) in patients who underwent surgical treatment in the last five years at the study center.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Invasive vulvar cancer (all infiltrating histotypes)
- •Age >18 years
排除标准
- •patient unable to follow the study procedures
- •patient with major depressive disorder
结局指标
主要结局
Accuracy, negative predictive value (NPV) and positive predictive value (PPV) of fine needle aspiration in the prediction of groin lymph node status
时间窗: within the first 30 days after surgery
Accuracy, negative predictive value (NPV) and positive predictive value (PPV) of ultrasound morphometry (USM) in the prediction of groin lymph node status
时间窗: within the first 30 days after surgery
次要结局
未报告次要终点
研究者
Prof. Giovanni Scambia
Professor
Catholic University of the Sacred Heart