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

Recruiting now

Conditions studied: Cervical Cancer, Cervical Intraepithelial Neoplasia (CIN), Risk Factors, Conservative Management

In brief

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.

Key facts

Study ID

NCT06967740

Run by

Nikola Janovska

People needed

200

Starts

2024-11-01

Expected to finish

2029-12-01

Last updated by the study team

2025-07-31

Who can join

Age: 18 and older, up to 46. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• University Hospital Kralovske Vinohrady — Prague, Czechia (enrolling)

Full record on ClinicalTrials.gov

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