RecruitingNCT06967740

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


Sponsor

Nikola Janovska

Enrollment

200 participants

Start Date

Nov 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 46 Years

Plain Language Summary

Simplified for easier understanding

This study is examining the best ways to treat pre-cancerous changes on the cervix (called high-grade cervical lesions) using minimally invasive approaches, with the goal of avoiding more aggressive surgery while still keeping women safe. **You may be eligible if...** - You are between 18 and 46 years old - A cervical biopsy has confirmed a high-grade pre-cancerous lesion - Your doctor can see the affected area clearly during a colposcopy exam - You have not been vaccinated against HPV - Your cervical cell test results do not show actual cancer - You have given informed consent **You may NOT be eligible if...** - Your cervical tests show signs of actual cancer (adenocarcinoma, squamous cell carcinoma, or related abnormal glandular cells pointing to cancer) - You are pregnant - You have a condition that affects immune function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

University Hospital Kralovske Vinohrady

Prague, Czechia

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NCT06967740


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