Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT06715592
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06715592
Study Brief:
Protocol Section:
NCT06715592