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NCT02955667 Clinical Trial

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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02955667
Other study ID # Fang Li
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 29, 2016
Last updated November 3, 2016
Start date December 2016

Study information
Verified date October 2016
Source Shanghai First Maternity and Infant Hospital
Contact n/a
Is FDA regulated No
Health authority China: Shanghai Municipal Commission of Health and Family Planning
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 600
Est. completion date
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 65 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• invivo microscopy group
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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Shanghai First Maternity and Infant Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary diagnostic accuracy rate 1 day (time of the examination) No
Secondary image accordance rate 1 day (time of the examination) No
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