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

Sponsor

Catholic University of the Sacred Heart (Other)

Overall Status

Unknown status

CT.gov ID

NCT02988765

Collaborator

(none)

120

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vulvar Cancer	Procedure: Groin ultrasound +/- fine needle aspiration	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Dec 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Invasive vulvar cancer (IVC) Vulvar carcinoma (stromal infiltration > 1 mm) Histotypes different from squamous cells carcinomas are included	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

Arm

Intervention/Treatment

Experimental: Invasive vulvar cancer (IVC)

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

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

Outcome Measures

Primary Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Gynecologic Oncology/Fondazione Policlinico Gemelli	Rome		Italy	00168

Sponsors and Collaborators

Catholic University of the Sacred Heart

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Giovanni Scambia, Professor, Catholic University of the Sacred Heart

ClinicalTrials.gov Identifier:

NCT02988765

Other Study ID Numbers:

Morpho-Node

First Posted:

Dec 9, 2016

Last Update Posted:

Dec 9, 2016

Last Verified:

Dec 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Prof. Giovanni Scambia, Professor, Catholic University of the Sacred Heart

Additional relevant MeSH terms:

Vulvar Neoplasms

Study Results

No Results Posted as of Dec 9, 2016