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

Vulvar Cancer Clinical Trial

— Morpho-Node  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02988765
• Other study ID #: Morpho-Node
• Status: Recruiting
• Phase: N/A
• First received: December 2, 2016
• Last updated: December 7, 2016
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: December 2016
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Vulvar Cancer
• Vulvar Neoplasms

Intervention

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

Locations

Country	Name	City	State
Italy	Division of Gynecologic Oncology/Fondazione Policlinico Gemelli	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No