NCT02955667

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 4, 2016

Completed
27 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Last Updated

November 4, 2016

Status Verified

October 1, 2016

Enrollment Period

2 years

First QC Date

October 29, 2016

Last Update Submit

November 3, 2016

Conditions

Cervical CancerCervical Precancer

Keywords

invivo microscopycolposcopycervical precancer and cancer

Outcome Measures

Primary Outcomes (1)

  • diagnostic accuracy rate

    1 day (time of the examination)

Secondary Outcomes (1)

  • image accordance rate

    1 day (time of the examination)

Study Arms (2)

invivo microscopy group

EXPERIMENTAL

patients receive invivo micro-colposcopy examination and do not have to receive the biopsies

Procedure: invivo microscopy group

normal group

OTHER

patients receive normal colposcopy examination and the biopsy specimens are sent for pathological HE staining and analysis

Procedure: normal group

Interventions

invivo microscopy groupPROCEDURE

patients receive invivo micro-colposcopy examination

invivo microscopy group
normal groupPROCEDURE

patients receive normal colposcopy examination and the biopsy specimens are sent for pathological HE staining and analysis

normal group

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cervical cytologic test result is HSIL
  • persistent infection with high-risk HPV
  • cervical pathological diagnosis is LSIL or HSIL

You may not qualify if:

  • acute infection of lower genital tract
  • the wound in lower genital tract
  • active bleeding in lower genital tract

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Cervical NeoplasmsUterine Cervical DysplasiaNeoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPrecancerous Conditions

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2016

First Posted

November 4, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2018

Last Updated

November 4, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share