NCT06967740

Epidemiological Factors and Optimization of Conservative Approaches to Precancerous Lesions of Female Reproductive Organs

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Nikola Janovska · Other Government
• Sex: Female
• Age: 18 Years – 46 Years
• Healthy volunteers: Not accepted

Summary

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

• Cervical Cancer
• Cervical Intraepithelial Neoplasia (CIN)
• Risk Factors
• Conservative Management

Timeline

• Start date: 2024-11-01
• Primary completion: 2028-12-01
• Completion: 2029-12-01
• First posted: 2025-05-13
• Last updated: 2025-07-31

Locations

1 site across 1 country: Czechia