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临床试验/NCT04783649
NCT04783649Unknown不适用

Clinical Validation of Cervical Cancer Screening Methods in St. Petersburg, Russia

N.N. Petrov National Medical Research Center of Oncology1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2020年7月13日最近更新:
适应症

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

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)

研究者

发起方
N.N. Petrov National Medical Research Center of Oncology
申办方类型
Other
责任方
Sponsor

研究点 (1)

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