Cervical CancerNCT06967740
Epidemiological Factors and Optimization of Conservative Approaches to Precancerous Lesions of Female Reproductive Organs
An observational study of Cervical Cancer and Cervical Intraepithelial Neoplasia (CIN), run by Nikola Janovska at 1 site in Czechia.
Trial summary
The primary aim of this study is to develop a recommended clinical practice guideline for managing women with HPV HR (high-risk human papillomavirus) positivity and cervical lesions. Read more about this study
- Who is it for?
- Ages 18 to 46 years, women only
- Conditions the study is for
- Cervical Cancer, Cervical Intraepithelial Neoplasia (CIN), Risk Factors
- Type of treatment
- Vaccines
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Nov 2024to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 46 years
- Women only
- No healthy volunteers
- Adult
Study population: Females with HG precancerous lesions of the cervix.
Who may be able to join
- Informed Consent
- cervical biopsy - HG lesion
- Age: 18-46 years
- colposcopicaly visible transformation zone
- HPV: Unvaccinated
- cytology all except AIS, adenocarcinoma, squamous cell carcinoma, AGC NEO
Who cannot join
- cytology AIS, AGC NEO, adenocarcinoma, squamous cell carcinoma
- immunosuppression
- active autoimmune disease
- history of cervical cryodestruction
- HPV vaccinated prior to start of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Kralovske Vinohrady
Prague, 10034
Lukas Rob, Prof., MUDr., Csc., +420 296472368, lukas.rob@fnkv.cz
Nikola Janovska, MUDr.
About this study
The primary aim of this study is to develop a recommended clinical practice guideline for managing women with HPV HR (high-risk human papillomavirus) positivity and cervical lesions. Additionally, in collaboration with the Bioptic Laboratory, the study will analyze the integration of HPV HR testing into screening programs for women aged 35, 45, and 55, with a focus on optimizing management strategies for HPV HR-positive women.
Research Objectives:
- Evaluate spontaneous regression/progression over two years based on HPV HR genotyping (three groups - according to Alinity: high, intermediate, and low risk).
- Assess spontaneous regression/progression over two years based on HPV HR genotyping and viral load in HPV-vaccinated vs. non-vaccinated patients.
- Evaluate spontaneous regression/progression over two years based on methylation results.
- Assess spontaneous regression/progression over two years based on CinTec plus results.
- Conditions
- Cervical Cancer, Cervical Intraepithelial Neoplasia (CIN), Risk Factors, Conservative Management
- Keywords
- Cervical Intraepithelial Neoplasia (CIN), Conservative management, Precancerous cervical lesions
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Unvaccinated | Without adjuvant vaccination for HPV | |
| Vaccinated | Adjuvantly vaccinated against HPV with Gardasil-9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate spontaneous regression/progression over a 2-year period according to HPV HR genotyping
Evaluate the risk of regression or progression of cervical lesion in patients with HG (high-grade) cervical precancerous lesion - according to stratification of HPV genotyping
Measured: 2 year follow up
To evaluate spontaneous regression/progression over a 2-year period according to methylation results
Evaluate the risk of regression or progression of cervical lesion in patients with HG cervical precancer - according to methylation test (FAM194A, miR124-2)
Measured: 2 year follow up
o evaluate spontaneous regression/progression over a 2-year period according to CinTec plus
Evaluate the risk of regression or progression of cervical lesion in patients with HG cervical precancer - according to CinTec plus test - mmunohistochemical marker utilizing two proteins - p16 and Ki67
Measured: 2 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Nov 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nikola Janovska
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Nikola Janovska, Faculty Hospital Kralovske Vinohrady
- Investigators
- Lukas Rob, Prof., MUDr., Csc., Principal investigator, Vascular surgery, University hospital Královské Vinohrady, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967740
- Sponsor's protocol ID
- EKVP/51/2024
- Status last verified
- Jul 2025
- First submitted
- 4 May 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee MH, Finlayson SJ, Gukova K, Hanley G, Miller D, Sadownik LA. Outcomes of Conservative Management of High Grade Squamous Intraepithelial Lesions in Young Women. J Low Genit Tract Dis. 2018 Jul;22(3):212-218. doi: 10.1097/LGT.0000000000000399.
PubMed 29762428Kyrgiou M, Athanasiou A, Paraskevaidi M, Mitra A, Kalliala I, Martin-Hirsch P, Arbyn M, Bennett P, Paraskevaidis E. Adverse obstetric outcomes after local treatment for cervical preinvasive and early invasive disease according to cone depth: systematic review and meta-analysis. BMJ. 2016 Jul 28;354:i3633. doi: 10.1136/bmj.i3633.
PubMed 27469988Depuydt CE, Jonckheere J, Berth M, Salembier GM, Vereecken AJ, Bogers JJ. Serial type-specific human papillomavirus (HPV) load measurement allows differentiation between regressing cervical lesions and serial virion productive transient infections. Cancer Med. 2015 Aug;4(8):1294-302. doi: 10.1002/cam4.473. Epub 2015 May 20.
PubMed 25991420
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Factors and Optimization of Conservative Approaches to Precancerous Lesions of Female Reproductive Organs
- ClinicalTrials.gov ID
- NCT06967740
- Acronym / sponsor ID
- EKVP/51/2024
- Conditions
- Cervical Cancer, Cervical Intraepithelial Neoplasia (CIN), Risk Factors, Conservative Management
- Keywords
- Cervical Intraepithelial Neoplasia (CIN), Conservative management, Precancerous cervical lesions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nikola JanovskaOther government
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 13 May 2025 (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.
The primary aim of this study is to develop a recommended clinical practice guideline for managing women with HPV HR (high-risk human papillomavirus) positivity and cervical lesions. Additionally, in collaboration with the Bioptic Laboratory, the study will analyze the integration of HPV HR testing into screening programs for women aged 35, 45, and 55, with a focus on optimizing management strategies for HPV HR-positive women.
Research Objectives:
- Evaluate spontaneous regression/progression over two years based on HPV HR genotyping (three groups - according to Alinity: high, intermediate, and low risk).
- Assess spontaneous regression/progression over two years based on HPV HR genotyping and viral load in HPV-vaccinated vs. non-vaccinated patients.
- Evaluate spontaneous regression/progression over two years based on methylation results.
- Assess spontaneous regression/progression over two years based on CinTec plus results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unvaccinated | – | –Without adjuvant vaccination for HPV |
| Vaccinated | – | –Adjuvantly vaccinated against HPV with Gardasil-9 |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Females with HG precancerous lesions of the cervix.
Key inclusion criteria (6 listed)
- Informed Consent
- cervical biopsy - HG lesion
- Age: 18-46 years
- colposcopicaly visible transformation zone
- HPV: Unvaccinated
Key exclusion criteria (5 listed)
- cytology AIS, AGC NEO, adenocarcinoma, squamous cell carcinoma
- immunosuppression
- active autoimmune disease
- history of cervical cryodestruction
- HPV vaccinated prior to start of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate spontaneous regression/progression over a 2-year period according to HPV HR genotyping
Time frame: 2 year follow up
Evaluate the risk of regression or progression of cervical lesion in patients with HG (high-grade) cervical precancerous lesion - according to stratification of HPV genotyping
To evaluate spontaneous regression/progression over a 2-year period according to methylation results
Time frame: 2 year follow up
Evaluate the risk of regression or progression of cervical lesion in patients with HG cervical precancer - according to methylation test (FAM194A, miR124-2)
o evaluate spontaneous regression/progression over a 2-year period according to CinTec plus
Time frame: 2 year follow up
Evaluate the risk of regression or progression of cervical lesion in patients with HG cervical precancer - according to CinTec plus test - mmunohistochemical marker utilizing two proteins - p16 and Ki67
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Background: PubMed 29762428Lee MH, Finlayson SJ, Gukova K, Hanley G, Miller D, Sadownik LA. Outcomes of Conservative Management of High Grade Squamous Intraepithelial Lesions in Young Women. J Low Genit Tract Dis. 2018 Jul;22(3):212-218. doi: 10.1097/LGT.0000000000000399.
- Background: PubMed 27469988Kyrgiou M, Athanasiou A, Paraskevaidi M, Mitra A, Kalliala I, Martin-Hirsch P, Arbyn M, Bennett P, Paraskevaidis E. Adverse obstetric outcomes after local treatment for cervical preinvasive and early invasive disease according to cone depth: systematic review and meta-analysis. BMJ. 2016 Jul 28;354:i3633. doi: 10.1136/bmj.i3633.
- Background: PubMed 25991420Depuydt CE, Jonckheere J, Berth M, Salembier GM, Vereecken AJ, Bogers JJ. Serial type-specific human papillomavirus (HPV) load measurement allows differentiation between regressing cervical lesions and serial virion productive transient infections. Cancer Med. 2015 Aug;4(8):1294-302. doi: 10.1002/cam4.473. Epub 2015 May 20.
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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.
Lukas Rob, Prof., MUDr., Csc. principal investigator
Vascular surgery, University hospital Královské Vinohrady, Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Cervical Intraepithelial Neoplasia (CIN), run by Nikola Janovska at 1 site 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lukas Rob, Prof. MUDr., Csc. (+420 296472368, lukas.rob@fnkv.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate spontaneous regression/progression over a 2-year period according to HPV HR genotyping (time frame: 2 year follow up). The study lists 3 primary outcomes in all. 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 NCT06967740, which also lists 3 linked publications.
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 31 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.