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

December 7, 2016 updated by: Prof. Giovanni Scambia, Catholic University of the Sacred Heart
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Recruiting
        • Division of Gynecologic Oncology/Fondazione Policlinico Gemelli
        • Sub-Investigator:
          • Simona Fragomeni, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accuracy, negative predictive value (NPV) and positive predictive value (PPV) of ultrasound morphometry (USM) in the prediction of groin lymph node status
Time Frame: within the first 30 days after surgery
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
Time Frame: within the first 30 days after surgery
within the first 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

December 2, 2016

First Submitted That Met QC Criteria

December 7, 2016

First Posted (Estimate)

December 9, 2016

Study Record Updates

Last Update Posted (Estimate)

December 9, 2016

Last Update Submitted That Met QC Criteria

December 7, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Morpho-Node

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vulvar Cancer

Clinical Trials on Groin ultrasound +/- fine needle aspiration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe