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Completed

NCT Number: NCT06258564

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

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

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Key information

Age range

18 year–99 year

Sex eligibility

Female

Study type

Observational

Primary location

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

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About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vaccination against human papillomavirus infection (HPV vaccination)

Biological

Women with or without HPV vaccination before or after excision

Primary outcomes

  1. CIN2+ recurrence rate

    Time frame: 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 outcomes

  1. CIN2+ recurrence frequency

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study title

The Adjuvant Effect of HPV Vaccination on Recurrence of Cervical Intraepithelial Neoplasia Grade 2 or Worse in Women Undergoing Conization: Retrospective Cohort Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 14, 2024
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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