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Clinical Trial 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.


Clinical Trial 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT02988765
Study type Interventional
Source Catholic University of the Sacred Heart
Contact
Status Recruiting
Phase N/A
Start date December 2016
Completion date December 2018

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