The Adjuvant Effect of HPV Vaccination on Recurrence of Cervical Precancer or Carcinoma in Women Undergoing Conization

Completed

• Conditions: Cervical Intraepithelial Neoplasia Grade 2/3; Recurrence
• Interventions: Biological: vaccination against human papillomavirus infection (HPV vaccination)

• Registration Number: NCT06258564
• Lead Sponsor: Charles University, Czech Republic

Brief Summary

Assessment of the association between human papillomavirus vaccination (HPV) and recurrences of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) in women undergoing conization.

Detailed Description

The implementation of vaccination against human papillomavirus (HPV) in the national immunization program for the young age cohort was subsequently extended to previously unvaccinated adult women who underwent conization due to cervical intraepithelial neoplasia grade 2 or worse (CIN2+).

These women are offered HPV vaccination, often completed post-excision. Observational and clinical studies conducted between 2010 and 2023 have demonstrated that HPV vaccination contributes to a \>70% reduction in CIN2+ recurrence in women after conization. However, the outcomes of these studies have not conclusively shown whether the adjuvant effect of HPV vaccination depends on the vaccine type (bi-, quadri-, or nona-valent), the timing and completeness of vaccination, and other factors.

This study aims to assess the mentioned factors and potentially reveal new ones, such as age, health status, etc. It is planned to be conducted using the laboratory records of women who underwent conization between 2010 and 2024, with their cervical screening examinations performed at the central laboratory UNILABS in Prague

Study Timeline

• Study First Submitted: 2024-02-06
• Study First Submitted QC: 2024-02-06
• Study First Posted: 2024-02-14
• Study Start: 2024-05-01
• Primary Completion: 2024-12-31
• Status Verified: 2025-01
• Study Completion: 2025-01-30
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12000

Inclusion Criteria

• Women >18 years, with conization for CIN2+ (HSIL)
• Women who had more than one examination during a follow-up period of >6 months.

Exclusion Criteria

• Women who underwent hysterectomy after conization.

• Women who had excision procedures other than cervical excision.
• Women who did not undergo any other cytological/histological examinations.
• Women with more than one conization before CIN2+ recurrence

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
single cohort of women with cervical excision for CIN2+	vaccination against human papillomavirus infection (HPV vaccination)	single cohort of women with cervical excision for CIN2+; those with HPV vaccination and those without HPV vaccination

Primary Outcome Measures

Name	Time	Method
CIN2+ recurrence rate	2010-2024	CIN2+ recurrence rate - obtained from the number of women with this find-ing related the number of women with no finding within the time period since the conization; The recurrence rate of CIN2+ will be assessed in relation to vaccination, vaccine type, vaccination completeness, etc., using specific uni-variate analysis (incidence rate ratio) and multivariate analysis (incidence rate ratio or hazard ratio, as appropriate)

Secondary Outcome Measures

Name	Time	Method
CIN2+ recurrence frequency	2010-2024	CIN2+ recurrence frequency - percentage proportion of women with this finding related to all women in follow-up; The recurrence frequency of CIN2+ will be assessed in relation to vaccination, vaccine type, vaccination completeness, etc., using specific univariate analysis (odds ratio, relative risk) and multivariate analysis (odds ratio, relative risk, as appropriate)

Trial Locations

Locations (2)

Department of Epidemiology and Biostatistics, Third Faculty of Medicine, Charles University; 🇨🇿 Prague, Czechia

Unilabs Pathology K.S; 🇨🇿 Praha, Czechia