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

Not Applicable

• Conditions: Cervical Cancer; Cervical Precancer
• Interventions: Procedure: invivo microscopy group; Procedure: normal group

• Registration Number: NCT02955667
• Lead Sponsor: Shanghai First Maternity and Infant Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-29
• Study First Submitted QC: 2016-11-03
• Last Update Submitted: 2016-11-03
• Study First Posted: 2016-11-04
• Last Update Posted: 2016-11-04
• Study Start: 2016-12
• Primary Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

1. cervical cytologic test result is HSIL
2. persistent infection with high-risk HPV
3. cervical pathological diagnosis is LSIL or HSIL

Exclusion Criteria

1. acute infection of lower genital tract
2. the wound in lower genital tract
3. active bleeding in lower genital tract

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
invivo microscopy group	invivo microscopy group	patients receive invivo micro-colposcopy examination and do not have to receive the biopsies
normal group	normal group	patients receive normal colposcopy examination and the biopsy specimens are sent for pathological HE staining and analysis

Primary Outcome Measures

Name	Time	Method
diagnostic accuracy rate	1 day (time of the examination)

Secondary Outcome Measures

Name	Time	Method
image accordance rate	1 day (time of the examination)