The Application of Invivo Microscopy Imaging in the Early... | NCT02955667

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

NCT02955667

Sponsor

Shanghai First Maternity and Infant Hospital

Status

Unknown status

Last Update Posted

Nov 4, 2016Estimated

Enrollment

600Estimated

Phase

Not Applicable

Conditions

Cervical Cancer
Cervical Precancer

Interventions

invivo microscopy group
normal group

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Dec 2018Estimated

Completion Date

Not provided

First Submitted Date

Oct 29, 2016

First Submission Date that Met QC Criteria

Nov 3, 2016

First Posted Date

Nov 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2016

Last Update Posted Date

Nov 4, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
invivo microscopy group	Procedure	patients receive invivo micro-colposcopy examination	invivo microscopy group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms
D002578	Uterine Cervical Dysplasia
D009369	Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided