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Automatic Early Melanoma Detection by Ultrahigh Resolution Three Dimensional Optical Coherence Tomography

Primary Purpose

Melanoma

Status
Unknown status
Phase
Locations
Taiwan
Study Type
Observational
Intervention
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Melanoma focused on measuring optical coherence tomography

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged older than 20 years old
  • Patients who had melanoma, melanoma in situ, and/or other benign pigmented lesions,
  • Patients who had non-melanoma skin cancers (basal cell carcinoma, or squamous cell carcinoma).
  • Patients who had precancerous skin lesions (Bowen's disease, actinicc keratosis)

Exclusion Criteria:

• Pregnant women.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Outcomes

Primary Outcome Measures

Ex vivo Tissue image.
Partial fragments of tissue specimens from melanoma, melanoma in situ, or other benign pigmented lesions will be used for imaging purpose by a optical coherence tomography.

Secondary Outcome Measures

Full Information

First Posted
January 7, 2015
Last Updated
October 13, 2016
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02335476
Brief Title
Automatic Early Melanoma Detection by Ultrahigh Resolution Three Dimensional Optical Coherence Tomography
Official Title
Automatic Early Melanoma Detection by Ultrahigh Resolution Three Dimensional Optical Coherence Tomography
Study Type
Observational

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators will use optical coherence tomography to detect the ex-vivo tissue image of surgical removed melanoma or other benign pigmented lesions of skin.
Detailed Description
The investigators will use an advanced high resolution 3D optical coherence tomography (OCT) technology to observe skin tissue images in ex vivo culture. Parts of melanoma or benign pigmented lesions specimens derived from biopsy or surgical excision specimen will be observed by 3D optical tomography. A tiny tissue fragment of melanoma or benign pigmented lesions will be taken from surgical specimen without interference normal pathological evaluation. The location of melanocytic cells in melanoma or benign tissue fragments will be mapped by the 3D optical coherence tomography (OCT). The 3D optic tomography system utilize a Ce:YAG optical fiber as light source and also combined with confocal microscopy. Taken together, these features made the 3D optic tomography system have very high resolution and suitable for single cell imaging. This study will not interfere with the normal medical practice and had no impact on patient's safety and health. All of the materials will be destroyed once the experiments are done. The enrollment criteria will be dermatological patients who need to surgical intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
optical coherence tomography

7. Study Design

Enrollment
100 (Anticipated)
Primary Outcome Measure Information:
Title
Ex vivo Tissue image.
Description
Partial fragments of tissue specimens from melanoma, melanoma in situ, or other benign pigmented lesions will be used for imaging purpose by a optical coherence tomography.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged older than 20 years old Patients who had melanoma, melanoma in situ, and/or other benign pigmented lesions, Patients who had non-melanoma skin cancers (basal cell carcinoma, or squamous cell carcinoma). Patients who had precancerous skin lesions (Bowen's disease, actinicc keratosis) Exclusion Criteria: • Pregnant women.
Study Population Description
Participants are patients at out-patient clinics or ward of Department of Dermatology, National Taiwan University Hospital.
Sampling Method
Non-Probability Sample
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JENGWEI TJIU
Phone
886-2-23123456
Ext
65315
Email
jengweitjiu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JENGWEI TJIU
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
10016
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
邱政偉
Phone
886-2-23123456
Ext
65315
Email
jengweitjiu@gmail.com

12. IPD Sharing Statement

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Automatic Early Melanoma Detection by Ultrahigh Resolution Three Dimensional Optical Coherence Tomography

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