临床试验/NCT02955667

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1日最近更新: 2016年11月4日

适应症

干预措施

试验速览

阶段: 不适用
发起方: Shanghai First Maternity and Infant Hospital
入组人数: 600
主要终点: diagnostic accuracy rate

研究概览研究设计入排标准研究组 & 干预措施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

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

研究组 & 干预措施

invivo microscopy group

Experimental

patients receive invivo micro-colposcopy examination and do not have to receive the biopsies

干预措施: invivo microscopy group (Procedure)

normal group

Other

patients receive normal colposcopy examination and the biopsy specimens are sent for pathological HE staining and analysis

干预措施: normal group (Procedure)

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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