Epidemiological Factors and Optimization of Conservative Approaches to Precancerous Lesions of Female Reproductive Organs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To evaluate spontaneous regression/progression over a 2-year period according to HPV HR genotyping
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 46 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •cytology AIS, AGC NEO, adenocarcinoma, squamous cell carcinoma
- •immunosuppression
- •active autoimmune disease
- •history of cervical cryodestruction
- •HPV vaccinated prior to start of the study
结局指标
主要结局
To evaluate spontaneous regression/progression over a 2-year period according to HPV HR genotyping
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
Nikola Janovska
Medical doctor, Department of Gynecology and Obstetrics
Faculty Hospital Kralovske Vinohrady