Actively Recruiting
Epidemiological Factors and Optimization of Conservative Approaches to Precancerous Lesions of Female Reproductive Organs
Led by Nikola Janovska · Updated on 2025-07-31
200
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Epidemiological Factors and Optimization of Conservative Approaches to Precancerous Lesions of Female Reproductive Organs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent
- Have a cervical biopsy confirming a high-grade lesion
- Aged between 18 and 46 years
- Colposcopically visible transformation zone
- Unvaccinated for HPV
- Cytology results excluding AIS, adenocarcinoma, squamous cell carcinoma, and AGC NEO
You will not qualify if you...
- Cytology showing AIS, AGC NEO, adenocarcinoma, or squamous cell carcinoma
- Immunosuppression
- Active autoimmune disease
- History of cervical cryodestruction
- HPV vaccination prior to study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital Kralovske Vinohrady
Prague, Czechia, 10034
Actively Recruiting
Research Team
L
Lukas Rob, Prof. MUDr., Csc.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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