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

NCT06715592 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-08-08

No results posted yet for this study

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.

Conditions

  • Paget Disease of the Vulva
  • Vulva Cancer

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.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Giacomo Corrado · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-23
Primary Completion
2025-03-31
Completion
2027-02-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06715592 on ClinicalTrials.gov