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

NCT ID: NCT02988765

Last Updated: 2016-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Vulvar Cancer

Keywords

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vulvar cancer inguinal lymph node lymph node status cytology core biopsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Invasive vulvar cancer (IVC)

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

Group Type EXPERIMENTAL

Groin ultrasound +/- fine needle aspiration

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

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Prof. Giovanni Scambia

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Division of Gynecologic Oncology/Fondazione Policlinico Gemelli

Rome, Rome, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Giorgia Garganese, MD

Role: primary

Simona M Fragomeni, MD

Role: backup

Other Identifiers

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Morpho-Node

Identifier Type: -

Identifier Source: org_study_id