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

Recurrence Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06258564
• Other study ID #: PAVIVE2024
• Secondary ID: Cooperatio 31 fu
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: January 2024
• Source: Charles University, Czech Republic
• Contact: Marek Petráš, assoc.prof.
• Phone: 00420 26710 2338
• Email: marek.petras[@]lf3.cuni.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: July 1, 2025
• Est. primary completion date: December 31, 2024
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia Grade 2/3
• Neoplasms
• Recurrence
• Uterine Cervical Dysplasia

Intervention

Biological:
• vaccination against human papillomavirus infection (HPV vaccination)
Women with or without HPV vaccination before or after excision

Locations

Country	Name	City	State
Czechia	Department of Epidemiology and Biostatistics, Third Faculty of Medicine, Charles University	Prague
Czechia	Unilabs Pathology K.S	Praha

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

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 Inf — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CIN2+ recurrence rate	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	CIN2+ recurrence frequency	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

External Links

•   Timing of HPV vaccination as adjuvant treatment of CIN2+ recurrence in women undergoing surgical excision: a meta-analysis and meta-regression