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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-46
SponsorNikola Janovska

About this trial

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 criteria

Qualifiers

Informed Consent

cervical biopsy - HG lesion

Age: 18-46 years

colposcopicaly visible transformation zone

Disqualifiers

cytology AIS, AGC NEO, adenocarcinoma, squamous cell carcinoma

immunosuppression

active autoimmune disease

history of cervical cryodestruction

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

200 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Nikola Janovska

Lead sponsor

Faculty Hospital Kralovske Vinohrady

Sponsor institution