Epidemiological Factors and Optimization of Conservative Approaches to Precancerous Lesions of Female Reproductive Organs
Key facts
- Where
- Prague, CzechiaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 46 years old?
Source: NCT06967740, who can take part
Where in Czechia
- University Hospital Kralovske VinohradyPrague, CzechiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nikola Janovska
- Trial code
- NCT06967740
- Record updated
- 31 July 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: HPV vaccinated prior to start of the study; active autoimmune disease; history of cervical cryodestruction; cytology AIS, AGC NEO, adenocarcinoma, squamous cell carcinoma; immunosuppression.