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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.

ENROLLING BY INVITATION NA Last updated 17 June 2025
What this trial tests

NA trial testing Sentinel Lymph Node Biopsy in first local recurrent vulvar carcinoma in Recurent Vulvar Carcinoma in 100 participants. Enrolling by invitation.

Timeline
1 August 2025
Primary endpoint
31 December 2027
31 December 2029

Quick facts

Lead sponsorHospital Universitario La Paz
PhaseNA
StatusENROLLING BY INVITATION
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment100
Start date1 August 2025
Primary completion31 December 2027
Estimated completion31 December 2029
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

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.

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Other Hospital Universitario La Paz trials

Trials by the same sponsor.

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Data sources for this page

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.

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