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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-01-30

Brief Summary

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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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Detailed Description

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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

Conditions

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Cervical Intraepithelial Neoplasia Grade 2/3 Recurrence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

vaccination against human papillomavirus infection (HPV vaccination)

Intervention Type BIOLOGICAL

Women with or without HPV vaccination before or after excision

Interventions

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vaccination against human papillomavirus infection (HPV vaccination)

Women with or without HPV vaccination before or after excision

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No