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
FEMALE
Min age
18 Years
Max age
46 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* cytology AIS, AGC NEO, adenocarcinoma, squamous cell carcinoma
* immunosuppression
* active autoimmune disease
* history of cervical cryodestruction
* HPV vaccinated prior to start of the study
Primary outcome measure(s)
To evaluate spontaneous regression/progression over a 2-year period according to HPV HR genotyping — 2 year follow up 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 — 2 year follow up 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 — 2 year follow up 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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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