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

Catholic University of the Sacred Heart

Status: Unknown

Conditions: Vulvar Cancer

Treatments: Procedure: Groin ultrasound +/- fine needle aspiration

Study type: Interventional

Funder types: Other

Identifiers

NCT02988765

Morpho-Node

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

120 participants in 1 patient group

Invasive vulvar cancer (IVC)

Experimental group

Description:

* Vulvar carcinoma (stromal infiltration \> 1 mm) * Histotypes different from squamous cells carcinomas are included

Treatment:

Procedure: Groin ultrasound +/- fine needle aspiration