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ACTIVE NOT RECRUITING
NCT06715592
PHASE2

ECT STUDY High-grade or Initially Invasive Vulva - GinOnc-ECT Study

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

Summary

Patients with a new diagnosis or recurrence of high-grade squamous precancerous lesions or initially non-invasive vulvar Paget's disease, who have not undergone other types of treatment, will be considered at the Fondazione Policlinico Universitario A. Gemelli - IRCCS - in Rome.

Official title: Monocentric Phase II Study on the Use of Electrochemotherapy in the Treatment of Paget's Disease and High-grade Squamous Precancerous Lesions or Initially Invasive Vulvar Lesions (GinOnc-ECT Study).

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2023-05-23

Completion Date

2027-02-01

Last Updated

2025-08-08

Healthy Volunteers

No

Interventions

DRUG

Bleomicina

Colposcopically guided ECT following intralesional administration / intravenous Bleomycin or intralesional Cisplatin according to ESOPE recommendations. Reassessment after 30 days by colposcopy and conization with acquisition of histological examination.

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio, Italy