Impact on Disease Relapse of HPV Vaccination in Women Treated With electrosurgical excision with diathermic loop (LEEP) for Cervical Intraepithelial Neoplasia.

Phase 1

• Conditions: Prevention of recurrence after a first episode of high-grade cervical intraepithelial neoplasia (CIN2 +) up to initially invasive cervical cancer (FIGO IA1); MedDRA version: 21.1Level: LLTClassification code 10008229Term: Cervical cancerSystem Organ Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code 10056576Term: Cervical intraepithelial neoplasiaSystem Organ Class: 100000004872; MedDRA version: 21.1Level: PTClassification code 10064328Term: Human papilloma virus test positiveSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-003507-19-IT
• Lead Sponsor: AZIENDA USL TOSCANA NORD OVEST

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 1220

Inclusion Criteria

1. Patients = 18 years old and ecog performance status = 1
2. 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)
3. No fever at the time of vaccination
4. No previous HPV vaccination
5. Ability to understand and write in Italian
6. Signature of informed consent and consent to personal data
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Patients enrolled in other clinical trials
2. History of allergic reaction or serious adverse events to previous vaccinations
3. Assessment of the state of pregnancy at the time of vaccination
4. Patients on immunosuppressive therapy
5. Subjects who received immunoglobulins or blood products in the 3 months prior to vaccination.
6. Thrombocytopenia or any other coagulation disorder that may lead to bleeding following intramuscular administration
7. Clinical criteria contraindicating the surgical act of conization
8. ECOG performance status =2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the impact of pre-surgical HPV 9-valent vaccination in patients subjected to conization for the management of high-grade cervical intraepithelial neoplasia (CIN2 +) and initially invasive cervical cancer in terms of possible reduction of recurrent post-surgical disease.;Secondary Objective: 1. Analysis of the possible impact of the 9-valent vaccine on the post-surgical natural history of HPV infection.<br>2. Evaluation of 9-valent HPV vaccination in patients treated for CIN2 + in terms of possible reduction of the follow-up scheme in the cervical screening program (investigation on the possible temporal reduction of post-surgical surveillance).;Primary end point(s): - evaluation of the reduction of disease recurrence (cervical intraepithelial neoplasia up to microinvasive cervical cancer) by comparing the number of recurrences in the two arms.;Timepoint(s) of evaluation of this end point: During the entire duration of the study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Analysis of the impact of the vaccine on prevalent post-surgery infections by comparing the prevalence of persistent HPV infections (duration greater than 12 months after surgery) in the two arms.; Analysis of the impact of the vaccine in the post-surgical surveillance times, comparison of the viral wash-out times (negativity of the HPV test), times of negativization of the pap test and of the colposcopic exam in the post-operative period: comparison of the overexposed times of negativization in the two arms.;Timepoint(s) of evaluation of this end point: During the entire duration of the study; During the entire duration of the study