Ultrasound Morphometric and Cyto/Histological Combined Pre-operative Assessment of Inguinal Lymph Node Status in Women With Invasive Vulvar Carcinoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Ultrasound Morphometric and Cyto/Histological Combined Pre-operative Assessment of Inguinal Lymph Node Status in Women With Invasive Vulvar Carcinoma

Conditions
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Vulvar Cancer

Intervention / Treatment
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* Procedure: Groin ultrasound +/- fine needle aspiration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Invasive vulvar cancer (all infiltrating histotypes) Age >18 years Exclusion Criteria: patient unable to follow the study procedures patient with major depressive disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Invasive vulvar cancer (IVC)<br>Vulvar carcinoma (stromal infiltration > 1 mm) Histotypes different from squamous cells carcinomas are included | Procedure: Groin ultrasound +/- fine needle aspiration<br>* Preoperative ultrasound morphometry (USM) of the inguino-femoral lymph nodes (IFLN). The FNAC and/or FNAB is performed in case of suspicious nodes, if at least one of the selected criteria is relieved during ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy, negative predictive value (NPV) and positive predictive value (PPV) of ultrasound morphometry (USM) in the prediction of groin lymph node status |  | within the first 30 days after surgery | 
| Accuracy, negative predictive value (NPV) and positive predictive value (PPV) of fine needle aspiration in the prediction of groin lymph node status |  | within the first 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vulvar cancer, inguinal lymph node, lymph node status, cytology, core biopsy