International Prospective Multicentre Study That Evaluate the Sentinel Lymph Node Detection Rate in Patients With First Local Recurrent Scamous Cell Carcinoma of the Vulva. (VULCA-NODE)

June 9, 2025 updated by: Myriam Gracia, Hospital Universitario La Paz

Sentinel Node Biopsy in Relapsed Vulvar Cancer. VULCA-NODE Study.

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • La Paz University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: First local recurrent vulvar carcinoma
Other: Sentinel Lymph Node Biopsy in first local recurrent vulvar carcinoma
All patients will undergo a local tumor radical excision and unilateral (if medial border > 1 cm from midline) or bilateral (medial border < or equal to 1 cm from midline) Sentinel Lymph Node procedure, followed by bilateral Inguinophemoral lymphadenectomy. .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the SLN detection rate in the first recurrent vulvar carcinoma setting.
Time Frame: From enrollment to the first 30 day after surgery
From enrollment to the first 30 day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario La Paz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

June 9, 2025

First Submitted That Met QC Criteria

June 9, 2025

First Posted (Actual)

June 17, 2025

Study Record Updates

Last Update Posted (Actual)

June 17, 2025

Last Update Submitted That Met QC Criteria

June 9, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HULP: PI-6605

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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