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.
Informed Consent
cervical biopsy - HG lesion
Age: 18-46 years
colposcopicaly visible transformation zone
cytology AIS, AGC NEO, adenocarcinoma, squamous cell carcinoma
immunosuppression
active autoimmune disease
history of cervical cryodestruction
Females with HG precancerous lesions of the cervix.
Cohort
Prospective
Not listed
To evaluate spontaneous regression/progression over a 2-year period according to HPV HR genotyping
Evaluate the risk of regression or progression of cervical lesion in patients with HG (high-grade) cervical precancerous lesion - according to stratification of HPV genotyping
To evaluate spontaneous regression/progression over a 2-year period according to methylation results
Evaluate the risk of regression or progression of cervical lesion in patients with HG cervical precancer - according to methylation test (FAM194A, miR124-2)
o evaluate spontaneous regression/progression over a 2-year period according to CinTec plus
Evaluate the risk of regression or progression of cervical lesion in patients with HG cervical precancer - according to CinTec plus test - mmunohistochemical marker utilizing two proteins - p16 and Ki67
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Nikola Janovska
Lead sponsor
Faculty Hospital Kralovske Vinohrady
Sponsor institution
