NCT06967740Recruiting
Epidemiological Factors and Optimization of Conservative Approaches to Precancerous Lesions of Female Reproductive Organs
Source: ClinicalTrials.gov · Last updated 31 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 4 May 2025
- Start date
- 1 Nov 2024
- Primary completion date
- Dec 2028
- Lead sponsor
- Nikola Janovska
- Diseases
- Cervical cancer
- NCT number
- NCT06967740
What you commit to
- Study type: Observational
- Planned participants: 200
- From 1 Nov 2024 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- HPV vaccinated prior to start of the study
Other illness
- active autoimmune disease
- history of cervical cryodestruction
Other
- cytology AIS, AGC NEO, adenocarcinoma, squamous cell carcinoma
- immunosuppression
Who the study is looking for
- 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
Age in the registry: 18 years to 46 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.