Clinical trial · Interventional
International Prospective Multicentre Study That Evaluate the Sentinel Lymph Node Detection Rate in Patients With First Local Recurrent Scamous Cell Carcinoma of the Vulva.
Sentinel Node Biopsy in Relapsed Vulvar Cancer. VULCA-NODE Study.
- 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)
Acronym: VULCA-NODE Study Title: Sentinel Node Biopsy in Relapsed Vulvar Cancer Primary Objetive: To evaluate the SLN detection rate in the first recurrent vulvar carcinoma setting. Secondary Objetives: * To compare the utility of different tracers in the detection of SLN for recurrent disease and the injection pattern. * To evaluate the surgical complications rate. * To analyze the nodal status by ultrastaging . * To assess the disease free and overall survival at 24 months from the first recurrence, as well as the dissemination pattern after the procedure. Study Design: International prospective multicentre study Inclusion Criteria: * First local recurrent squamous cell carcinoma of the vulva (SCC). * Unifocal, smaller or equal than 4 cm vulvar tumor not involving urethra, vagina or anus. * No distant or groin metastasis. * To be able to understand the study and sign informed consent. * Over 18 years old. * To be able to undergo planned follow up. Exclusion Criteria: * Multifocal recurrent disease of the vulva. * Previous bilateral IFL. * Synchronous, non-curable second malignancy. Timing: 4 years
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 |
|---|---|---|---|
| Recurent Vulvar Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sentinel Lymph Node Biopsy in first local recurrent vulvar carcinoma | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- First local recurrent vulvar carcinoma
- interventionNames
- Other: Sentinel Lymph Node Biopsy in first local recurrent vulvar carcinoma
Primary outcomes (1)
- measure
- To evaluate the SLN detection rate in the first recurrent vulvar carcinoma setting.
- timeFrame
- From enrollment to the first 30 day after surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * First local recurrent squamous cell carcinoma of the vulva (SCC). * Unifocal, smaller or equal than 4 cm vulvar tumor not involving urethra, vagina or anus. * No distant or groin metastasis. * To be able to understand the study and sign informed consent. * Over 18 years old. * To be able to undergo planned follow up. Exclusion Criteria: * Multifocal recurrent disease of the vulva. * Previous bilateral IFL. * Synchronous, non-curable second malignancy.
References
Publications (0)
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