Status:
NOT_YET_RECRUITING
Impact on Disease Relapse of HPV Vaccination in Women Treated With LEEP for Cervical Intraepithelial Neoplasia. HOPE9
Lead Sponsor:
Alessandro Ghelardi
Conditions:
Cervical Intraepithelial Neoplasia
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
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+ (hi...
Detailed Description
Rationale: In 2006 HPV vaccination was licensed for primary prevention programs worldwide. Only a few years after, several studies have raised new scenarios about HPV related diseases with strong imp...
Eligibility Criteria
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
- Patients enrolled in other clinical studies
- History of allergic reaction or serious adverse events to previous vaccinations
- Positive pregnancy test at the time of vaccination
- Patient in treatment with immunosuppressive therapy
- Subjects who received immunoglobulins or blood products in 3 months prior to vaccination.
- Thrombocytopenia or any other clotting disorder that may lead to bleeding as a result of intramuscular administration
- Clinical criteria contraindicating the surgical act of conization
- ECOG performance status ≥2
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
1220 Patients enrolled
Trial Details
Trial ID
NCT03848039
Start Date
December 1 2020
End Date
May 1 2028
Last Update
November 5 2020
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