Recurent Vulvar CarcinomaVULCA-NODENCT07023601
International Prospective Multicentre Study That Evaluate the Sentinel Lymph Node Detection Rate in Patients With First Local Recurrent Scamous Cell Carcinoma of the Vulva.
A study testing Sentinel Lymph Node Biopsy in first local recurrent vulvar carcinoma in people with Recurent Vulvar Carcinoma, run by Hospital Universitario La Paz at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurent Vulvar Carcinoma
- What is being tested?
- Sentinel Lymph Node Biopsy in first local recurrent vulvar carcinoma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Multifocal recurrent disease of the vulva.
- Previous bilateral IFL.
- Synchronous, non-curable second malignancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
Read more
- 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
- Recurent Vulvar Carcinoma
- Being tested
- Sentinel Lymph Node Biopsy in first local recurrent vulvar carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel Lymph Node Biopsy in first local recurrent vulvar carcinomaOther
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. .
| Study group | Role | What they receive |
|---|---|---|
| First local recurrent vulvar carcinoma | Experimental | Not described Receives: Other: Sentinel Lymph Node Biopsy in first local recurrent vulvar carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the SLN detection rate in the first recurrent vulvar carcinoma setting.
Measured: From enrollment to the first 30 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurent Vulvar CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myriam Gracia, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023601
- Sponsor's protocol ID
- HULP: PI-6605
- Acronym
- VULCA-NODE
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Node Biopsy in Relapsed Vulvar Cancer. VULCA-NODE Study.
- ClinicalTrials.gov ID
- NCT07023601
- Acronym / sponsor ID
- VULCA-NODE / HULP: PI-6605
- Conditions
- Recurent Vulvar Carcinoma
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First local recurrent vulvar carcinoma | Experimental | Other: Sentinel Lymph Node Biopsy in first local recurrent vulvar carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Multifocal recurrent disease of the vulva.
- Previous bilateral IFL.
- Synchronous, non-curable second malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentinel Lymph Node Biopsy in first local recurrent vulvar carcinomaAll 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. . | Other | First local recurrent vulvar carcinoma |
Primary outcome
To evaluate the SLN detection rate in the first recurrent vulvar carcinoma setting.
Time frame: From enrollment to the first 30 day after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel Lymph Node Biopsy in first local recurrent vulvar carcinoma in people with Recurent Vulvar Carcinoma, run by Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the SLN detection rate in the first recurrent vulvar carcinoma setting. (time frame: From enrollment to the first 30 day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.