Optical Tomographic Scanner for Skin Lesions | NCT02891291

Studies
Optical Tomographic Scanner for Skin Lesions

NCT02891291

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Sep 21, 2016Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

Skin Cancer, Benign Skin Tumor, Inflammatory Skin Disease

Interventions

Not provided

Countries

Taiwan

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

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

May 2019Estimated

Completion Date

May 2019Estimated

First Submitted Date

Sep 1, 2016

First Submission Date that Met QC Criteria

Sep 1, 2016

First Posted Date

Sep 7, 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

Sep 20, 2016

Last Update Posted Date

Sep 21, 2016Estimated

Name	Class
Ministry of Science and Technology, Taiwan	OTHER_GOV

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

Optical coherence tomography is technology widely used in medicine. In this study, the investigators will use an optical tomographic scanner to scan skin tissue image.

Detailed Description

The investigators will use optical tomographic scanner to scan skin specimen and obtain tissue images. Part of skin specimen obtained from skin biopsy or surgery will be scanned.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

Retention

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Skin tissue image obtained.	Part of the skin specimen from surgery or biopsy will be scanned.	1 week

Secondary Outcomes

Measure	Description	Time Frame
Skin histopathology	The skin specimen will be stained with hematoxylin and eosin. Histopathological pictures (or findings) will be obtained and correlate with the scanned images.	2 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Patient who receive skin biopsy or surgery due to skin cancers, benign skin diseases, or inflammatory skin diseases.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patient's age are between 20 to 100 years old. Patients who receive skin biopsy or surgery at Department of Dermatology, National Taiwan University Hospital, Taiwan.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
JENGWEI TJIU	Contact	886-23123456	65315	jengweitjiu@gmail.com

Overall Officials

Name	Affiliation	Role
JENGWEI TJIU, MDPHD	NTUH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei	Taiwan	10002	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

No plan to share data.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012878	Skin Neoplasms
D003872	Dermatitis

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided