A Single-Arm Comparison Study with Cervical Cytology to Evaluate the Efficacy of HPV Screening in Pregnant Women

Yokohama City University Hospital Obstetrics and Gynecology0 个研究点目标入组 5,000 人开始时间: 2024年10月29日最近更新: 2025年2月26日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 5,000
主要终点: detection rate of CIN2+

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Single Arm Study
干预模型: Single Assignment
主要目的: Diagnostic Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 30age old over 至 No limit（—）
性别: Female

入选标准

•30 years of age or older
•Less than 17 weeks pregnant

排除标准

•No cervix
•Undergoing treatment or history of invasive cancer of the cervix
•Undergoing treatment or follow-up at a medical institution for precancerous lesion of the cervix or suspected precancerous lesion of the cervix
•Other cases in which the subject is judged to be inappropriate by the physician's judgment.

结局指标

主要结局

detection rate of CIN2+

时间窗: immediately after early pregnancy testing

To test the non-inferiority of HPV screening to cytology screening for the detection rate of CIN2+ immediately after early pregnancy testing using a mathematical statistical model.

次要结局

Descriptive statistics
Comparison of lesion detection rates
Comparison of risk of lesion progression
Rate of definitive results
Prognosis

研究者

发起方

Yokohama City University Hospital Obstetrics and Gynecology

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Unknown

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