<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01676168</url>
  </required_header>
  <id_info>
    <org_study_id>201205098RIC</org_study_id>
    <nct_id>NCT01676168</nct_id>
  </id_info>
  <brief_title>To Study Gene Expression of Postburn Hypertrophic Scar</brief_title>
  <official_title>To Study Gene Expression of Postburn Hypertrophic Scar</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim: To compare the gene expression of postburn hypertrophic scar with normal skin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Postburn hypertrophic scar (HS) remains a challenging problem. Although varied&#xD;
      clinical therapeutic methods have been used, none of them has been widely accepted as a&#xD;
      standard care. As hypertrophic scar is hereditary, gene therapy can be a potential tool for&#xD;
      scar treatment. To investigate the correlation between the clinical presentation of the&#xD;
      hypertrophic scar and its gene expression, we propose an analysis of gene expression in the&#xD;
      hypertrophic scar using DNA microarray and Real-Time Quantitative PCR. The study result may&#xD;
      form the base of clinical treatment.&#xD;
&#xD;
      Methods and Materials: Thirty scar patients requiring surgical treatment in NTUH burn center&#xD;
      will be enrolled into the study. Inclusion criteria: (1) Age between 20 and 80 (2) Patients&#xD;
      with postburn hypertrophic scar require surgical treatment.&#xD;
&#xD;
        1. Hypertrophic scar and normal skin collection: Under Clinical Trial Informed Consent of&#xD;
           Research Ethic Committee, scar and normal skin specimen of 1x1cm2 each will be collected&#xD;
           and transported to tissue bank with a vacuum low temperature container. The specimen&#xD;
           will be kept in a -80℃ refrigerator.&#xD;
&#xD;
        2. RNA extraction from skin tissue: The RNA extraction will be performed using kit&#xD;
           available in the market. Spectrophotometer and gel electrophoresis will be used to&#xD;
           measure the purity and concentration of RNA.&#xD;
&#xD;
        3. Gene expression analysis: DNA microarray and Real-Time Quantitative PCR will be used to&#xD;
           analyze RNA expression of hypertrophic scar and normal skin.&#xD;
&#xD;
      Statistics: Student's t-test will be used to compare statistically gene expression between&#xD;
      hypertrophic scar and normal skin. P &lt; 0.05 will be considered as statistical significance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2012</start_date>
  <primary_completion_date type="Anticipated">July 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Cicatrix, Hypertrophic</condition>
  <arm_group>
    <arm_group_label>hypertrophic scar</arm_group_label>
    <description>1x1cm2 hypertrophic scar of post-burn patients are taked by visiting staff when they accept scar-reconstructive surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal skin</arm_group_label>
    <description>When the patient accept skin grafting surgery, visiting staff will take 1x1cm2 normal skin.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Hypertrophic scar from post-burn patient&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The patient have hypertrophic scar.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age20~80, hypertrophic scar patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no specific limitation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kean Eng Yeong, college</last_name>
    <role>Study Chair</role>
    <affiliation>NTUH Burn lab</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kean Eng Yeong, college</last_name>
    <phone>886-2-23123456</phone>
    <phone_ext>65648</phone_ext>
    <email>smartpace88@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>10002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kean Eng Yeong, college</last_name>
      <phone>886-2-23123456</phone>
      <phone_ext>65648</phone_ext>
      <email>smartpace88@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Kean Eng Yeong, College</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>August 28, 2012</last_update_submitted>
  <last_update_submitted_qc>August 28, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 30, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertrophy</mesh_term>
    <mesh_term>Cicatrix, Hypertrophic</mesh_term>
    <mesh_term>Cicatrix</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01676168
org study id: 201205098RIC
nct id: NCT01676168
lead sponsor: 
has dmc: No
Aim: To compare the gene expression of postburn hypertrophic scar with normal skin.
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.

        1. 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.

        2. 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.

        3. 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.
observational model: Case-Control
time perspective: Prospective
arm group label: hypertrophic scar
description: 1x1cm2 hypertrophic scar of post-burn patients are taked by visiting staff when they accept scar-reconstructive surgery.
arm group label: normal skin
description: When the patient accept skin grafting surgery, visiting staff will take 1x1cm2 normal skin.
Hypertrophic scar from post-burn patient
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Kean Eng Yeong, college
role: Study Chair
affiliation: NTUH Burn lab
last name: Kean Eng Yeong, college
phone: 886-2-23123456
phone ext: 65648
email: smartpace88@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
responsible party type: Sponsor
mesh term: Hypertrophy
mesh term: Cicatrix, Hypertrophic
mesh term: Cicatrix