Epidemiological Factors and Optimization of Conservative Approaches to Precancerous Lesions of Female Reproductive Organs
NCT ID: NCT06967740
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2024-11-01
2029-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Unvaccinated
Without adjuvant vaccination for HPV
No interventions assigned to this group
Vaccinated
Adjuvantly vaccinated against HPV with Gardasil-9
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* cervical biopsy - HG lesion
* Age: 18-46 years
* colposcopicaly visible transformation zone
* HPV: Unvaccinated
* cytology all except AIS, adenocarcinoma, squamous cell carcinoma, AGC NEO
Exclusion Criteria
* immunosuppression
* active autoimmune disease
* history of cervical cryodestruction
* HPV vaccinated prior to start of the study
18 Years
46 Years
FEMALE
No
Sponsors
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Nikola Janovska
OTHER_GOV
Responsible Party
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Nikola Janovska
Medical doctor, Department of Gynecology and Obstetrics
Principal Investigators
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Lukas Rob, Prof., MUDr., Csc.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Kralovske Vinohrady
Locations
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University Hospital Kralovske Vinohrady
Prague, , Czechia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Kyrgiou 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.
Depuydt 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.
Other Identifiers
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EKVP/51/2024
Identifier Type: -
Identifier Source: org_study_id
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