NCT02988765

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vulvar Cancer

Interventions

Type	Name	Description
PROCEDURE	Groin ultrasound +/- fine needle aspiration	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

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2016-12-09
• Last updated: 2016-12-09

Locations

1 site across 1 country: Italy