NCT03848039Not yet recruitingPhase 3
Impact on Disease Relapse of HPV Vaccination in Women Treated With LEEP for Cervical Intraepithelial Neoplasia. HOPE9
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.
Source: ClinicalTrials.gov · Last updated 5 Nov 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1220 (estimated)
- First submitted
- 19 Feb 2019
- Start date
- Dec 2020
- Primary completion date
- Dec 2022
- Lead sponsor
- Alessandro Ghelardi
- Diseases
- Cervical cancer
- NCT number
- NCT03848039
- EU CT number
- 2024-513704-34-00
- EudraCT number
- 2018-003507-19
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1220
- From Dec 2020 to the primary completion date, Dec 2022
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Thrombocytopenia or any other clotting disorder that may lead to bleeding as a result of intramuscular administration
Other
- Patients enrolled in other clinical studies
- Positive pregnancy test at the time of vaccination
- ECOG performance status ≥2
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Sanitaria Locale Cn2 Alba-Bra Coordinator of this site? Confirm its status | Alba | Italy | Completed |
| Azienda Unita Sanitaria Locale Toscana Nord Ovest Coordinator of this site? Confirm its status | Massa | Italy | Completed |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Istituto Europeo di Oncologia s.r.l Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Istituto Nazionale dei Tumori, Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Coordinator of this site? Confirm its status | Palermo | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana Coordinator of this site? Confirm its status | Treviso | Italy | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.