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

November 3, 2016 updated by: Shanghai First Maternity and Infant Hospital
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: invivo microscopy group
patients receive invivo micro-colposcopy examination and do not have to receive the biopsies
Procedure: invivo microscopy group
patients receive invivo micro-colposcopy examination
Other: normal group
patients receive normal colposcopy examination and the biopsy specimens are sent for pathological HE staining and analysis
Procedure: normal group
patients receive normal colposcopy examination and the biopsy specimens are sent for pathological HE staining and analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
diagnostic accuracy rate
Time Frame: 1 day (time of the examination)
1 day (time of the examination)

Secondary Outcome Measures

Outcome Measure
Time Frame
image accordance rate
Time Frame: 1 day (time of the examination)
1 day (time of the examination)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai First Maternity and Infant Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 29, 2016

First Submitted That Met QC Criteria

November 3, 2016

First Posted (Estimate)

November 4, 2016

Study Record Updates

Last Update Posted (Estimate)

November 4, 2016

Last Update Submitted That Met QC Criteria

November 3, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fang Li

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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