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

NCT ID: NCT02955667

Last Updated: 2016-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Brief Summary

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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

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Conditions

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Cervical Cancer Cervical Precancer

Keywords

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invivo microscopy colposcopy cervical precancer and cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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invivo microscopy group

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

Group Type EXPERIMENTAL

invivo microscopy group

Intervention Type PROCEDURE

patients receive invivo micro-colposcopy examination

normal group

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

Group Type OTHER

normal group

Intervention Type PROCEDURE

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

Interventions

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invivo microscopy group

patients receive invivo micro-colposcopy examination

Intervention Type PROCEDURE

normal group

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai First Maternity and Infant Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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Fang Li

Identifier Type: -

Identifier Source: org_study_id