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

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Brief Title

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

Official Title

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

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.
    

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


Primary Outcome

Accuracy, negative predictive value (NPV) and positive predictive value (PPV) of ultrasound morphometry (USM) in the prediction of groin lymph node status


Condition

Vulvar Cancer

Intervention

Groin ultrasound +/- fine needle aspiration

Study Arms / Comparison Groups

 Invasive vulvar cancer (IVC)
Description:  Vulvar carcinoma (stromal infiltration > 1 mm)
Histotypes different from squamous cells carcinomas are included

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

120

Start Date

December 2016

Completion Date

December 2018

Primary Completion Date

December 2018

Eligibility Criteria

        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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT02988765

Organization ID

Morpho-Node


Responsible Party

Principal Investigator

Study Sponsor

Catholic University of the Sacred Heart


Study Sponsor

, , 


Verification Date

December 2016