Cervical Intraepithelial Neoplasia Grade 2/3NCT06258564
The Adjuvant Effect of HPV Vaccination on Recurrence of Cervical Precancer or Carcinoma in Women Undergoing Conization
An observational study of Cervical Intraepithelial Neoplasia Grade 2/3 and Recurrence, run by Charles University, Czech Republic at 2 sites in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia Grade 2/3, Recurrence
- What is being tested?
- vaccination against human papillomavirus infection (HPV vaccination)
- Type of treatment
- Vaccines
- How many people
- 12,000 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 May 2024to 30 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- Adult, Older adult
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.
Who may be able to join
- Women >18 years, with conization for CIN2+ (HSIL)
- Women who had more than one examination during a follow-up period of >6 months.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
Department of Epidemiology and Biostatistics, Third Faculty of Medicine, Charles University
Prague, 10000
Unilabs Pathology K.S
Prague, 16000
About this study
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
Assessment of the association between human papillomavirus vaccination (HPV) and recurrences of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) in women undergoing conization.
Read the 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
- Being tested
- vaccination against human papillomavirus infection (HPV vaccination)
- Keywords
- HPV, vaccination, CIN2+ recurrence, conization
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaccination against human papillomavirus infection (HPV vaccination)Biological
Women with or without HPV vaccination before or after excision
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: vaccination against human papillomavirus infection (HPV vaccination) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2010-2024
Secondary outcomes (1)
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)
Measured: 2010-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 May 2024
- Primary completion31 Dec 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Intraepithelial Neoplasia Grade 2/3Studies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marek Petráš, assoc.prof., Principal investigator, Department of Epidemiology and Biostatistics, Third Faculty of Medicine, Charles University, Prague, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258564
- Sponsor's protocol ID
- PAVIVE2024
- Other IDs
- Cooperatio 31 fund
- Status last verified
- Jan 2025
- First submitted
- 6 Feb 2024
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37553234
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06258564
- Acronym / sponsor ID
- PAVIVE2024
- Keywords
- HPV, vaccination, CIN2+ recurrence, conization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,000 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single cohort of women with cervical excision for CIN2+ | – | Biological: vaccination against human papillomavirus infection (HPV vaccination)single cohort of women with cervical excision for CIN2+; those with HPV vaccination and those without HPV vaccination |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Women >18 years, with conization for CIN2+ (HSIL)
- Women who had more than one examination during a follow-up period of >6 months.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vaccination against human papillomavirus infection (HPV vaccination)Women with or without HPV vaccination before or after excision | Biological | single cohort of women with cervical excision for CIN2+ |
Primary outcome
CIN2+ recurrence rate
Time frame: 2010-2024
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)
1 secondary outcome
CIN2+ recurrence frequency
Time frame: 2010-2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Results publication: PubMed 37553234Petras 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.
- Timing of HPV vaccination as adjuvant treatment of CIN2+ recurrence in women undergoing surgical excision: a meta-analysis and meta-regressionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marek Petráš, assoc.prof. principal investigator
Department of Epidemiology and Biostatistics, Third Faculty of Medicine, Charles University, Prague, Czech Republic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Intraepithelial Neoplasia Grade 2/3 and Recurrence, run by Charles University, Czech Republic at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CIN2+ recurrence rate (time frame: 2010-2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06258564, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.