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

February 11, 2025 updated by: Charles University, Czech Republic

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

12000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia, 10000
        • Department of Epidemiology and Biostatistics, Third Faculty of Medicine, Charles University
      • Praha, Czechia, 16000
        • Unilabs Pathology K.S

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
single cohort of women with cervical excision for CIN2+
single cohort of women with cervical excision for CIN2+; those with HPV vaccination and those without HPV vaccination
Biological: vaccination against human papillomavirus infection (HPV vaccination)
Women with or without HPV vaccination before or after excision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2010-2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2010-2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Investigators

  • Principal Investigator: Marek Petráš, assoc.prof., Department of Epidemiology and Biostatistics, Third Faculty of Medicine, Charles University, Prague, Czech Republic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

January 30, 2025

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAVIVE2024
  • Cooperatio 31 fund (Other Grant/Funding Number: Charles University, Prague)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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