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

Not Applicable

• Conditions: Vulvar Cancer
• Interventions: Procedure: Groin ultrasound +/- fine needle aspiration

• Registration Number: NCT02988765
• Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary

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

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.

Study Timeline

• Status Verified: 2016-12
• Study Start: 2016-12
• Study First Submitted: 2016-12-02
• Study First Submitted QC: 2016-12-07
• Last Update Submitted: 2016-12-07
• Study First Posted: 2016-12-09
• Last Update Posted: 2016-12-09
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Invasive vulvar cancer (IVC)	Groin ultrasound +/- fine needle aspiration	* Vulvar carcinoma (stromal infiltration \> 1 mm) * Histotypes different from squamous cells carcinomas are included

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Division of Gynecologic Oncology/Fondazione Policlinico Gemelli; 🇮🇹 Rome, Italy