Cervical Cancer, Cervical Intraepithelial Neoplasia (CIN), Conservative Management, Risk Factors
Conditions
Keywords
Cervical Intraepithelial Neoplasia (CIN), Conservative management, Precancerous cervical lesions
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.
Interventions
None listed
Sponsors
Nikola Janovska
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Czechia
Contacts
Primary ContactLukas Rob, Prof. MUDr., Csc.
Outcome results
None listed