patients with newly diagnosed or recurrent high-grade or initially invasive precancerous squamous lesions of the vulva and non-invasive vulvar Paget's disease
Conditions
Brief summary
Evaluation of histological pathological response of vulvar lesions and non-invasive Paget's disease on surgical specimens 30 days after electrochemotherapy according to RECIST criteria
Detailed description
Safety of the method evaluated using the CTCAE criteria v. 5.0, Assessment of HPV persistence by HPV test at the 6-month visit, Duration of disease control in follow-up, Symptomatology assessment using specific questionnaires (VAS, EQ-5D, FSFI) filled in by patients before treatment and one, three, six and twelve months after treatment
Interventions
DRUGBLEOMYCIN
DRUGCISPLATIN
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of histological pathological response of vulvar lesions and non-invasive Paget's disease on surgical specimens 30 days after electrochemotherapy according to RECIST criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the method evaluated using the CTCAE criteria v. 5.0, Assessment of HPV persistence by HPV test at the 6-month visit, Duration of disease control in follow-up, Symptomatology assessment using specific questionnaires (VAS, EQ-5D, FSFI) filled in by patients before treatment and one, three, six and twelve months after treatment | — |
Countries
Italy
Outcome results
None listed