Epidemiological Factors and Optimization of Conservative Approaches to Precancerous Lesions of Female Reproductive Organs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- To evaluate spontaneous regression/progression over a 2-year period according to HPV HR genotyping
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 46 Years (Adult)
- Sex
- Female
- Accepts 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
Outcomes
Primary Outcomes
To evaluate spontaneous regression/progression over a 2-year period according to HPV HR genotyping
Time Frame: 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
Time Frame: 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
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Nikola Janovska
Medical doctor, Department of Gynecology and Obstetrics
Faculty Hospital Kralovske Vinohrady