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

Shanghai First Maternity and Infant Hospital

Status: Unknown

Conditions: Cervical Precancer; Cervical Cancer

Treatments: Procedure: normal group; Procedure: invivo microscopy group

Study type: Interventional

Funder types: Other

Identifiers

NCT02955667

Fang Li

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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600 participants in 2 patient groups

invivo microscopy group

Experimental group

Description:

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

Treatment:

Procedure: invivo microscopy group

normal group

Other group

Description:

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

Treatment:

Procedure: normal group