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)

Madrid Health Service

Status

Invitation-only

Conditions

Recurent Vulvar Carcinoma

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07023601

HULP: PI-6605

Details and patient eligibility

About

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

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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