Last reviewed · How we verify
NCT07023601: VULCA-NODE
International Prospective Multicentre Study That Evaluate the Sentinel Lymph Node Detection Rate in Patients With First Local Recurrent Scamous Cell Carcinoma of the Vulva.
NA trial testing Sentinel Lymph Node Biopsy in first local recurrent vulvar carcinoma in Recurent Vulvar Carcinoma in 100 participants. Enrolling by invitation.
31 December 2027
Quick facts
| Lead sponsor | Hospital Universitario La Paz |
|---|---|
| Phase | NA |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 August 2025 |
| Primary completion | 31 December 2027 |
| Estimated completion | 31 December 2029 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Sentinel Lymph Node Biopsy in first local recurrent vulvar carcinoma
Conditions studied
- Recurent Vulvar Carcinoma — all drugs for Recurent Vulvar Carcinoma →
Sponsor
Hospital Universitario La Paz
Who can join
18 and older, female only, with Recurent Vulvar Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07023601
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07023601 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Universitario La Paz
- Last refreshed: 17 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07023601.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing