Cervical Intraepithelial Neoplasia Grade 2/3, Recurrence
Conditions
Keywords
HPV, vaccination, CIN2+ recurrence, conization
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
Interventions
BIOLOGICALvaccination against human papillomavirus infection (HPV vaccination)
Women with or without HPV vaccination before or after excision
Sponsors
Charles University, Czech Republic
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Czechia
Outcome results
None listed