NCT02955667Unknown不适用

The Application of Invivo Microscopy Imaging in the Early Diagnosis of Cervical Cancer

Shanghai First Maternity and Infant Hospital0 个研究点目标入组 600 人开始时间: 2016年12月最近更新: 2016年11月4日

研究概览

简要总结

This study intends to carry out a prospective, randomized controlled trial to research and development a new invivo microscopy based on the technology which is combined with high-definition microscopy and colposcopy，so as to diagnose cervical lesion directly and non-invasively by observing cervical tissues and cells, which makes it possible to diagnose cervical cancer without wounds.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Diagnostic
盲法: Double (Participant, Outcomes Assessor)

入排标准

年龄范围: 20 Years 至 65 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•cervical cytologic test result is HSIL
•persistent infection with high-risk HPV
•cervical pathological diagnosis is LSIL or HSIL

排除标准

•acute infection of lower genital tract
•the wound in lower genital tract
•active bleeding in lower genital tract

结局指标

主要结局

diagnostic accuracy rate

时间窗: 1 day (time of the examination)

次要结局

image accordance rate(1 day (time of the examination))

研究者

发起方

Shanghai First Maternity and Infant Hospital

申办方类型

Other

责任方

Sponsor

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