ClinicalTrials.gg
Enrolling by invitationNCT07023601VULCA-NODEUpdated Jun 17, 2025

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

An interventional study of Sentinel Lymph Node Biopsy in first local recurrent vulvar carcinoma in Recurent Vulvar Carcinoma, sponsored by Hospital Universitario La Paz. Enrolling by invitation at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-17.

Sponsored by Hospital Universitario La Paz · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

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
02

Conditions studied

  • Recurent Vulvar Carcinoma
03

In context

Lead sponsor

Hospital Universitario La Paz is the lead sponsor of 56 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  • To be able to understand the study and sign .
  • Over 18 years old.
  • To be able to undergo planned follow up.

Exclusion criteria

Exclusion Criteria:

  • Multifocal recurrent disease of the vulva.
  • Previous bilateral IFL.
  • Synchronous, non-curable second .
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    First local recurrent vulvar carcinoma

    Other: Sentinel Lymph Node Biopsy in first local recurrent vulvar carcinoma

Interventions

  • OtherSentinel 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. .

06

What researchers measure

Primary outcomes

  1. To evaluate the SLN detection rate in the first recurrent vulvar carcinoma setting.

    Time frame: From enrollment to the first 30 day after surgery

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07023601
Lead sponsor
Hospital Universitario La Paz
Responsible party
Myriam Gracia (Myriam Gracia and Ignacio Zapardiel, Hospital Universitario La Paz) — Principal investigator
First posted
Jun 17, 2025
Start date
Aug 1, 2025 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Jun 17, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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