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

Shanghai First Maternity and Infant Hospital600 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

600

Conditions

Cervical Cancer Cervical Precancer

Interventions

invivo microscopy groupPROCEDURE

patients receive invivo micro-colposcopy examination

normal groupPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

diagnostic accuracy rate

Time frame: 1 day (time of the examination)

Secondary Outcomes

image accordance rate

Time frame: 1 day (time of the examination)

Data from ClinicalTrials.gov

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