Clinical Validation of Cervical Cancer Screening Methods in St. Petersburg, Russia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Sensitivity
研究概览
简要总结
This single-institution cross-sectional non-inferiority validation study evaluates alternative techniques and tests for primary cervical cancer screening programs in Russia, particularly: local cytology staining techniques, local HPV tests.
详细描述
Cervical cytology practices are different across the world. While the Pap test became the cornerstone of the highly-effective cervical cancer screening in the countries that initially implemented population-based programs in the 60s and the 70s, alternative staining techniques were implemented in the Soviet Union. The tradition to apply other staining techniques than conventional Pap test remained unchanged in the national screening program implemented in the 2010s in Russia. As a new alternative option HPV testing showed effectiveness in screening women older than 30. The acceptable sensitivity and specificity of a screening test are crucial in population-based screening, that is why validation against "the gold standard" should be the first step in the process of program implementation. The objective of this study is to evaluate alternative techniques and tests for primary cervical cancer screening programs in Russia, particularly: local cytology staining techniques, local HPV tests in the population of 25-65 yo women without prior history of malignancy referred to colposcopy enriched with a population sample of women from several primary healthcare facilities referred to a primary screening test.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 25 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 25 and 65 years old Referral to colposcopy or to a primary screening test Signed informed consent
排除标准
- •Prior history of malignancy or cervical dysplasia Prior history of cervical dysplasia
结局指标
主要结局
Sensitivity
时间窗: 24 months
Cervical screening tests sensitivity
Specificity
时间窗: 24 months
Cervical screening tests specificity
次要结局
- Cervical dysplasia prevalence(24 months)
- HPV prevalence by type(24 months)
