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Trial Title:
The Adjuvant Effect of HPV Vaccination on Recurrence of Cervical Precancer or Carcinoma in Women Undergoing Conization
NCT ID:
NCT06258564
Condition:
Cervical Intraepithelial Neoplasia Grade 2/3
Recurrence
Conditions: Official terms:
Neoplasms
Carcinoma in Situ
Uterine Cervical Dysplasia
Recurrence
Conditions: Keywords:
HPV
vaccination
CIN2+ recurrence
conization
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Biological
Intervention name:
vaccination against human papillomavirus infection (HPV vaccination)
Description:
Women with or without HPV vaccination before or after excision
Arm group label:
single cohort of women with cervical excision for CIN2+
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.
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
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
99 Years
Locations:
Facility:
Name:
Department of Epidemiology and Biostatistics, Third Faculty of Medicine, Charles University
Address:
City:
Prague
Zip:
10000
Country:
Czechia
Status:
Not yet recruiting
Contact:
Last name:
Marek Petráš, assoc.prof.
Phone:
00420 26710 2338
Email:
marek.petras@lf3.cuni.cz
Contact backup:
Last name:
Pavel Dlouhý, assoc.prof.
Email:
pavel.dlouhy@lf3.cuni.cz
Investigator:
Last name:
Danuše Lomozová, Mgr.
Email:
Principal Investigator
Facility:
Name:
Unilabs Pathology K.S
Address:
City:
Praha
Zip:
16000
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Markéta Trnková, MD.
Phone:
00420 255 775 288
Email:
marketa.trnkova@unilabs.com
Start date:
May 1, 2024
Completion date:
July 1, 2025
Lead sponsor:
Agency:
Charles University, Czech Republic
Agency class:
Other
Source:
Charles University, Czech Republic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06258564
https://sti.bmj.com/content/99/8/561
