ECT STUDY High-grade or Initially Invasive Vulva - GinOnc-ECT Study (NCT06715592) | Clinical Trial Compass
Active — Not RecruitingPhase 2
ECT STUDY High-grade or Initially Invasive Vulva - GinOnc-ECT Study
Italy18 participantsStarted 2023-05-23
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histological diagnosis of de novo or recurrent vulvar VIN 2-3, microinvasive vulvar carcinoma in situ, and non-invasive vulvar Paget's disease
* Positivity for high-risk cervical and/or vaginal HPV
* Age \> 18 years
* Karnofsky performance status \>70%
* Informed consent to participate in the study
* No surgical treatment indication due to disease extension, patient refusal, anesthesiological or reconstructive reasons
* Negative Beta-hCG measurement in urine (pregnancy test or urinary beta-HCG) or in blood (plasma beta-HCG)
Exclusion Criteria:
* Patients with a histological diagnosis of adenocarcinoma
* Patients with concomitant and/or previous tumors
* Current pregnancy and breastfeeding
* Chronic renal insufficiency
* Chronic renal dysfunction
* Patients with a cardiac pacemaker
* Epilepsy
* Lung diseases with moderate/severe respiratory insufficiency
* Poor lung function or abnormal lung function
* Significant coagulation disorders
* Coagulation abnormalities (platelets \< 70,000/mm³ and INR \> 1.5)
* Ongoing HPV vaccination
* Patients with immunosuppressive conditions or treatments (HIV positive)
* Allergy to Bleomycin and/or Cisplatin
* Cumulative doses of 250 mg/m² of Bleomycin received
What they're measuring
1
Evaluation of the activity of electrochemotherapy in the treatment of vulvar lesions and noninvasive M. of Paget
Timeframe: 30 days post treatment and then Outpatient visit at 3, 6 and 12 months from procedures.