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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Invasive vulvar cancer (IVC) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Groin ultrasound +/- fine needle aspiration | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Gynecologic Oncology/Fondazione Policlinico Gemelli | Recruiting | Rome | Rome | 00168 | Italy |
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| ID | Term |
|---|---|
| D014846 | Vulvar Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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