- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01676168
To Study Gene Expression of Postburn Hypertrophic Scar
Study Overview
Status
Conditions
Detailed Description
Background: Postburn hypertrophic scar (HS) remains a challenging problem. Although varied clinical therapeutic methods have been used, none of them has been widely accepted as a standard care. As hypertrophic scar is hereditary, gene therapy can be a potential tool for scar treatment. To investigate the correlation between the clinical presentation of the hypertrophic scar and its gene expression, we propose an analysis of gene expression in the hypertrophic scar using DNA microarray and Real-Time Quantitative PCR. The study result may form the base of clinical treatment.
Methods and Materials: Thirty scar patients requiring surgical treatment in NTUH burn center will be enrolled into the study. Inclusion criteria: (1) Age between 20 and 80 (2) Patients with postburn hypertrophic scar require surgical treatment.
- Hypertrophic scar and normal skin collection: Under Clinical Trial Informed Consent of Research Ethic Committee, scar and normal skin specimen of 1x1cm2 each will be collected and transported to tissue bank with a vacuum low temperature container. The specimen will be kept in a -80℃ refrigerator.
- RNA extraction from skin tissue: The RNA extraction will be performed using kit available in the market. Spectrophotometer and gel electrophoresis will be used to measure the purity and concentration of RNA.
- Gene expression analysis: DNA microarray and Real-Time Quantitative PCR will be used to analyze RNA expression of hypertrophic scar and normal skin.
Statistics: Student's t-test will be used to compare statistically gene expression between hypertrophic scar and normal skin. P < 0.05 will be considered as statistical significance.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Kean Eng Yeong, college
- Phone Number: 65648 886-2-23123456
- Email: smartpace88@hotmail.com
Study Locations
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Taipei, Taiwan, 10002
- Recruiting
- National Taiwan University Hospital
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Contact:
- Kean Eng Yeong, college
- Phone Number: 65648 886-2-23123456
- Email: smartpace88@hotmail.com
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Principal Investigator:
- Kean Eng Yeong, College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- age20~80, hypertrophic scar patient
Exclusion Criteria:
- no specific limitation
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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hypertrophic scar
1x1cm2 hypertrophic scar of post-burn patients are taked by visiting staff when they accept scar-reconstructive surgery.
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normal skin
When the patient accept skin grafting surgery, visiting staff will take 1x1cm2 normal skin.
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Collaborators and Investigators
Investigators
- Study Chair: Kean Eng Yeong, college, NTUH Burn lab
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201205098RIC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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