Clinical trial NCT06258564: The Adjuvant Effect of HPV Vaccination on Recurrence of Cervical Precancer or Carcinoma in Women Undergoing Conization
Official title: The Adjuvant Effect of HPV Vaccination on Recurrence of Cervical Intraepithelial Neoplasia Grade 2 or Worse in Women Undergoing Conization: Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Intraepithelial Neoplasia Grade 2/3
Recurrence
Keywords: HPV
vaccination
CIN2+ recurrence
conization
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 12000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population consists of women who underwent conization for CIN2+, and the laboratory examination of conization and other samples was conducted at the central laboratory of UNILABS. The follow-up period for the population must be at least 6 months, with at least one negative finding before a recurrence of CIN2+ is identified.

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

Eligibility criteria: 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

Primary outcomes:
measure: CIN2+ recurrence rate
timeFrame: 2010-2024
Secondary outcomes:
measure: CIN2+ recurrence frequency
timeFrame: 2010-2024
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Department of Epidemiology and Biostatistics, Third Faculty of Medicine, Charles University
city: Praha
country: Czechia
facility: Unilabs Pathology K.S
Study officials:
affiliation: Department of Epidemiology and Biostatistics, Third Faculty of Medicine, Charles University, Prague, Czech Republic
name: Marek Petráš, assoc.prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Petras M, Dvorak V, Lomozova D, Macalik R, Neradova S, Dlouhy P, Malinova J, Rosina J, Lesna IK. Timing of HPV vaccination as adjuvant treatment of CIN2+ recurrence in women undergoing surgical excision: a meta-analysis and meta-regression. Sex Transm Infect. 2023 Dec;99(8):561-570. doi: 10.1136/sextrans-2023-055793. Epub 2023 Aug 8.