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:
- cervical cytologic test result is HSIL
- persistent infection with high-risk HPV
- cervical pathological diagnosis is LSIL or HSIL
Exclusion Criteria:
- acute infection of lower genital tract
- the wound in lower genital tract
- 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
|
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
|
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.
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
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.