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

Primary Purpose

Vulvar Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Groin ultrasound +/- fine needle aspiration

About this trial

This is an interventional diagnostic trial for Vulvar Cancer focused on measuring vulvar cancer, inguinal lymph node, lymph node status, cytology, core biopsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Division of Gynecologic Oncology/Fondazione Policlinico GemelliRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Invasive vulvar cancer (IVC)

Arm Description

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

Outcomes

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

Accuracy, negative predictive value (NPV) and positive predictive value (PPV) of fine needle aspiration in the prediction of groin lymph node status

Secondary Outcome Measures

Full Information

NCT ID

NCT02988765

First Posted

December 2, 2016

Last Updated

December 7, 2016

Sponsor

Catholic University of the Sacred Heart

1. Study Identification

Unique Protocol Identification Number

NCT02988765

Brief Title

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

Acronym

Morpho-Node

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vulvar Cancer

Keywords

vulvar cancer, inguinal lymph node, lymph node status, cytology, core biopsy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Invasive vulvar cancer (IVC)

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Groin ultrasound +/- fine needle aspiration

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Division of Gynecologic Oncology/Fondazione Policlinico Gemelli

City

Rome

ZIP/Postal Code

00168

Country

Italy

Individual Site Status

Recruiting

Facility Contact: