The Application of Invivo Microscopy Imaging in the Early Diagnosis of Cervical Cancer
Primary Purpose
Cervical Cancer, Cervical Precancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
invivo microscopy group
normal group
Sponsored by
About this trial
This is an interventional diagnostic trial for Cervical Cancer focused on measuring invivo microscopy, colposcopy, cervical precancer and cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
invivo microscopy group
normal group
Arm Description
patients receive invivo micro-colposcopy examination and do not have to receive the biopsies
patients receive normal colposcopy examination and the biopsy specimens are sent for pathological HE staining and analysis
Outcomes
Primary Outcome Measures
diagnostic accuracy rate
Secondary Outcome Measures
image accordance rate
Full Information
NCT ID
NCT02955667
First Posted
October 29, 2016
Last Updated
November 3, 2016
Sponsor
Shanghai First Maternity and Infant Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02955667
Brief Title
The Application of Invivo Microscopy Imaging in the Early Diagnosis of Cervical Cancer
Official Title
The Application of Invivo Microscopy Imaging in the Early Diagnosis of Cervical Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai First Maternity and Infant Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Cervical Precancer
Keywords
invivo microscopy, colposcopy, cervical precancer and cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
invivo microscopy group
Arm Type
Experimental
Arm Description
patients receive invivo micro-colposcopy examination and do not have to receive the biopsies
Arm Title
normal group
Arm Type
Other
Arm Description
patients receive normal colposcopy examination and the biopsy specimens are sent for pathological HE staining and analysis
Intervention Type
Procedure
Intervention Name(s)
invivo microscopy group
Intervention Description
patients receive invivo micro-colposcopy examination
Intervention Type
Procedure
Intervention Name(s)
normal group
Intervention Description
patients receive normal colposcopy examination and the biopsy specimens are sent for pathological HE staining and analysis
Primary Outcome Measure Information:
Title
diagnostic accuracy rate
Time Frame
1 day (time of the examination)
Secondary Outcome Measure Information:
Title
image accordance rate
Time Frame
1 day (time of the examination)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Application of Invivo Microscopy Imaging in the Early Diagnosis of Cervical Cancer
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