Tests HPV vaccine to reduce cervical disease returning after surgery
Tests an HPV vaccine against placebo in women treated for cervical precancer.
Plain-language title generated from the registry record
Registry title: Impact on Disease Relapse of HPV Vaccination in Women Treated With LEEP for Cervical Intraepithelial Neoplasia. HOPE9
Key facts
- Where
- Alba, Massa, Milan, Naples, Palermo, Rome, and Treviso, ItalySee the 9 sites
- Phase
- Phase 3
Where in Italy
- Azienda Sanitaria Locale Cn2 Alba-BraAlba, ItalyNo longer taking part
- Azienda Unita Sanitaria Locale Toscana Nord OvestMassa, ItalyNo longer taking part
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyNo longer taking part
- Istituto Europeo di Oncologia s.r.lMilan, ItalyNo longer taking part
- Ospedale San Raffaele S.r.l.Milan, ItalyNo longer taking part
- Istituto Nazionale dei Tumori,Naples, ItalyNo longer taking part
- Azienda Ospedaliera Universitaria Policlinico Paolo GiacconePalermo, ItalyNo longer taking part
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyNo longer taking part
- Azienda Unita' Locale Socio Sanitaria N. 2 Marca TrevigianaTreviso, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alessandro Ghelardi
- Trial code
- NCT03848039EU 2024-513704-34-00
- Record updated
- 5 November 2020
- Original description
This study evaluates the impact on disease relapse of presurgical 9-valent HPV vaccination versus placebo vaccination in women treated with LEEP (loop electrosurgical excision procedure) for CIN2+ (high grade cervical intraepithelial neoplasia) and initially invasive cervical cancer.Read full original descriptionShow less
A Randomised, Double-Blind, Placebo-Controlled, Phase III Study to Investigate the Efficacy of Presurgical 9-valent HPV Vaccination in Women Treated With LEEP for CIN 2+ and Initially Invasive Cervical Cancer.
This study evaluates the impact on disease relapse of presurgical 9-valent HPV vaccination versus placebo vaccination in women treated with LEEP (loop electrosurgical excision procedure) for CIN2+ (high grade cervical intraepithelial neoplasia) and initially invasive cervical cancer.
Inclusion: Patients aged ≥ 18 and ecog performance status ≤ 1; Patients with a diagnosis of high-grade cervical intraepithelial neoplasia or initially invasive cervical cancer (histological results ≥ 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 Italian; Signed informed and privacy consent.
Exclusion: History of allergic reaction or serious adverse events to previous vaccinations; Patient in treatment with immunosuppressive therapy; Subjects who received immunoglobulins or blood products in 3 months prior to vaccination; Clinical criteria contraindicating the surgical act of conization; Thrombocytopenia or any other clotting disorder that may lead to bleeding as a result of intramuscular administration; Patients enrolled in other clinical studies; Positive pregnancy test at the time of vaccination; ECOG performance status ≥2.