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

NCT06258564 | Completed

• 2 other identifiers: PAVIVE2024Cooperatio 31 fund
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Cervical Intraepithelial Neoplasia Grade 2/3; Recurrence

Keywords

HPV; vaccination; CIN2+ recurrence; conization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• CIN2+ recurrence frequency

  2010-2024

Study Arms (1)

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)

Interventions

vaccination against human papillomavirus infection (HPV vaccination) BIOLOGICAL

Women with or without HPV vaccination before or after excision

single cohort of women with cervical excision for CIN2+

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Women \>18 years, with conization for CIN2+ (HSIL)
• Women who had more than one examination during a follow-up period of \>6 months.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (2)

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

Prague, 10000, Czechia

Location

Unilabs Pathology K.S

Prague, 16000, Czechia

Location

Related 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 Infect. 2023 Dec;99(8):561-570. doi: 10.1136/sextrans-2023-055793. Epub 2023 Aug 8.

  PMID: 37553234 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marek Petráš, assoc.prof.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: May 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 30, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)