search
Back to results

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
Shanghai First Maternity and Infant Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Cancer focused on measuring invivo microscopy, colposcopy, cervical precancer and cancer

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

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

    First Posted
    October 29, 2016
    Last Updated
    November 3, 2016
    Sponsor
    Shanghai First Maternity and Infant Hospital
    search

    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

    We'll reach out to this number within 24 hrs