The Adjuvant Effect of HPV Vaccination on Recurrence of Cervical Intraepithelial Neoplasia Grade 2 or Worse in Women Undergoing Conization: Retrospective Cohort Study
Data Collection
Collected from past medical records and data - RetrospectivePathologic Processes+1
+ Recurrence
+ Pathological Conditions, Signs and Symptoms
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: May 1, 2024
Actual date on which the first participant was enrolled.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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.12000 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 99 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Department of Epidemiology and Biostatistics, Third Faculty of Medicine, Charles University
Prague, CzechiaOpen Department of Epidemiology and Biostatistics, Third Faculty of Medicine, Charles University in Google MapsUnilabs Pathology K.S
Prague, Czechia