Clinical trial · Interventional
Ultrasound Morphometric and Cyto/Histological Combined Pre-operative Assessment of Inguinal Lymph Node Status in Women With Invasive Vulvar Carcinoma
NCT02988765CI-TRIAL-00025103Morpho-NodeunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Groin ultrasound +/- fine needle aspiration | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Invasive vulvar cancer (IVC)
- description
- * Vulvar carcinoma (stromal infiltration \> 1 mm) * Histotypes different from squamous cells carcinomas are included
- interventionNames
- Procedure: Groin ultrasound +/- fine needle aspiration
Primary outcomes (2)
- measure
- Accuracy, negative predictive value (NPV) and positive predictive value (PPV) of ultrasound morphometry (USM) in the prediction of groin lymph node status
- timeFrame
- within the first 30 days after surgery
- measure
- Accuracy, negative predictive value (NPV) and positive predictive value (PPV) of fine needle aspiration in the prediction of groin lymph node status
- timeFrame
- within the first 30 days after surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.