Optimizing management of precancerous cervical lesions in women with HPV
Official title: Epidemiological Factors and Optimization of Conservative Approaches to Precancerous Lesions of Female Reproductive Organs
Run by Faculty Hospital Kralovske Vinohrady · NCT06967740 · Data updated 2026-11-12
This study is testing how to better manage cervical lesions in women with high-risk HPV by looking at how these lesions change over two years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 46 Years |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | Faculty Hospital Kralovske Vinohrady Government |
| Locations | 1 site (Prague) |
| Status | Recruiting |
| Started | November 1, 2024 |
| Main results expected | December 2028 |
| Study ends | December 2029 |
| Registry record updated | July 31, 2025 |
| Trial ID | NCT06967740 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women aged 18-46 with high-grade cervical lesions who are unvaccinated against HPV.
✕Probably not a fit
Patients with a history of cervical cancer or those who have been vaccinated against HPV prior to the study will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to develop clinical practice guidelines for managing women with high-risk HPV positivity and cervical lesions. It will evaluate the spontaneous regression or progression of these lesions over two years, focusing on various factors such as HPV genotyping, viral load, and methylation results. The study will analyze data from women aged 35, 45, and 55 to optimize management strategies for HPV HR-positive patients, in collaboration with the Bioptic Laboratory.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for women with precancerous cervical lesions, potentially reducing the incidence of cervical cancer.
How similar studies have gone: Other studies have shown success in optimizing management strategies for HPV-related conditions, indicating that this approach is promising.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * cytology AIS, AGC NEO, adenocarcinoma, squamous cell carcinoma * immunosuppression * active autoimmune disease * history of cervical cryodestruction * HPV vaccinated prior to start of the study
Where it's running
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University Hospital Kralovske Vinohrady
Prague, Czechia Recruiting
Study contacts
- Principal investigator: Lukas Rob, Prof., MUDr., Csc. — Vascular surgery, University hospital Královské Vinohrady, Prague
- Study coordinator: Lukas Rob, Prof. MUDr., Csc.
- Email: lukas.rob@fnkv.cz
- Phone: +420 296472368
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.