Phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy of pre-surgical HPV9-valente vaccination in women treated with loop electrosurgical excision (LEEP) for high-grade cervical intraepithelial neoplasia (CIN2+) up to cervical cancer initially invasive (FIGO IA1) - HOPE 9 STUDY
- Conditions
- cervical cancerMedDRA version: 21.1Level: LLTClassification code: 10008229Term: Cervical cancer Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-513704-34-00
- Lead Sponsor
- Azienda Unita Sanitaria Locale Toscana Nord Ovest
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1220
Patients >= 18 years old and ecog performance status <= 1, Patients diagnosed with high-grade cervical intraepithelial neoplasia or initially invasive cervical cancer (histological findings = CIN2 + and = Ia1 according to the FIGO staging of cervical cancer), No fever at the time of vaccination, No previous HPV vaccination, Ability to understand and write in Italian, Signature of informed consent and consent to personal data
Patients enrolled in other clinical trials, History of allergic reaction or serious adverse events to previous vaccinations, Assessment of the state of pregnancy at the time of vaccination, Patients on immunosuppressive therapy, Subjects who received immunoglobulins or blood products in the 3 months prior to vaccination., Thrombocytopenia or any other coagulation disorder that may lead to bleeding following intramuscular administration, Clinical criteria contraindicating the surgical act of conization, ECOG performance status =2
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method