Vulvar Cancer
Conditions
Keywords
vulvar cancer, inguinal lymph node, lymph node status, cytology, core biopsy
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.
Interventions
PROCEDUREGroin 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
Sponsors
Catholic University of the Sacred Heart
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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 | 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 |
Countries
Italy
Outcome results
None listed