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ECT STUDY High-grade or Initially Invasive Vulva - GinOnc-ECT Study
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
Conditions
Interventions
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