<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/NCT02244749</url>
  </required_header>
  <id_info>
    <org_study_id>20107851</org_study_id>
    <secondary_id>SEED Grant 405181-66496</secondary_id>
    <nct_id>NCT02244749</nct_id>
  </id_info>
  <brief_title>Role of Metabolic Enzymes in Non-Melanoma Skin Cancer</brief_title>
  <official_title>Role of Metabolic Enzymes in Non-Melanoma Skin Cancer: Potential for Informative Biomarkers and Therapeutic Targets</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Irvine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chao Family Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beckman Laser Institute University of California Irvine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Irvine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The researcher can proved that certain compounds play an important role in the prevention of&#xD;
      skin cancer. Researcher can use specific compounds, which classified as metabolic enzymes,&#xD;
      and lower concentrations and complete absent in skin cancer cells. Researcher can biopsies of&#xD;
      normal skin and precancerous or cancerous lesions, and can compare the concentrations of&#xD;
      these compounds to determine the difference between the two areas. The result can lead to&#xD;
      further understanding of skin cancers and pre-cancers. Because skin cancers and pre-cancers&#xD;
      are so common, any knowledge would be very useful for many people in the future and may be&#xD;
      used for development of future treatments or prevention strategies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Biopsy procedure will be done at the Beckman Laser Institute or at the Dermatology Clinic&#xD;
      Gottschalk Medical Plaza, of University of California, Irvine. Standard procedure of punch&#xD;
      biopsy will be done in the areas determined by the physician researchers. The normal skin&#xD;
      biopsy will be obtained from an area of skin without any suspicious lesions located on an&#xD;
      area of the body. Biopsy specimens will be stored frozen at Beckman Laser Institute&#xD;
      chemistry-lab for research and will be assigned with subject ID number, there will be no&#xD;
      personnel health information attach to the skin specimens. There will be no cost to the&#xD;
      subject or their insurer for participation in this study, except in the specific scenario of&#xD;
      a suspected skin cancer that would undergo biopsy regardless of participation in this study.&#xD;
      The time commitment for each subject is approximately 1 hour for each set of biopsies.&#xD;
&#xD;
      Researchers can test the hypothesis that expression of key metabolic enzymes is reduced&#xD;
      and/or lost during skin cancer progression. Total ribonucleic acid, a single-stranded&#xD;
      biologic molecule involved in gene transcription, regulation, and translation, can be&#xD;
      isolated from biopsied skin specimens. Quantitative Real-Time can be performed to determine&#xD;
      the expression levels of several key metabolic enzymes.&#xD;
&#xD;
      Metabolic enzymes regulate several vital signaling pathways in the human body. Some examples&#xD;
      include hormone and bioactive lipid regulation. Aberrant regulation of these signaling&#xD;
      pathways can lead to human diseases including cancer.&#xD;
&#xD;
      Recent evidence has shown that metabolic enzyme call UGT in the genes call&#xD;
      UDP-glucuronosyltransferases were shown to have significantly reduced expression in breast&#xD;
      tumors compared with normal breast tissue from the same patients This observed loss of&#xD;
      expression is hypothesized to be causal as these two enzymes are responsible for estrogen&#xD;
      metabolism.&#xD;
&#xD;
      However, relatively little is known about metabolic enzymes and skin cancer. We have&#xD;
      preliminary data that UGT enzyme expression is lost during melanoma progression which allows&#xD;
      deregulated lipoxygenase signaling.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>expression levels of metabolic enzymes in normal skin versus precancerous lesions or skin cancer</measure>
    <time_frame>1 month</time_frame>
    <description>Overall, compare normal skin versus precancerous lesions or skin cancer from the same individual. Paired tests of samples are selected from the same subjects.&#xD;
10 actinic keratosis samples,&#xD;
10 basal cell carcinoma samples&#xD;
20 squamous cell carcinoma samples&#xD;
Normal skin control biopsy from the same subject will be collected.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">26</enrollment>
  <condition>Skin Cancer</condition>
  <arm_group>
    <arm_group_label>skin specimen</arm_group_label>
    <description>skin specimen</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>skin specimen</intervention_name>
    <description>skin specimen</description>
    <arm_group_label>skin specimen</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study population will be selected from University of California Irvine Medical Cencal&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or Female are age18 years and older&#xD;
&#xD;
          -  Have normal skin and a skin lesion of interest&#xD;
&#xD;
          -  Willing to have skin biopsies on those areas&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male or Female are under 18 years of age&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristen Kelly, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beckman Laser Institute, UCI</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beckman Laser Institute</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gottschalk Medical Plaza, 1 Medical Plaza Drive</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>October 28, 2022</last_update_submitted>
  <last_update_submitted_qc>October 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Irvine</investigator_affiliation>
    <investigator_full_name>Beckman Laser Institute and Medical Center</investigator_full_name>
    <investigator_title>Kirsten Kelly, M.D., Professor of Dermatology and Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skin Neoplasms</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/NCT02244749
org study id: 20107851
secondary id: SEED Grant 405181-66496
nct id: NCT02244749
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The researcher can proved that certain compounds play an important role in the prevention of
      skin cancer. Researcher can use specific compounds, which classified as metabolic enzymes,
      and lower concentrations and complete absent in skin cancer cells. Researcher can biopsies of
      normal skin and precancerous or cancerous lesions, and can compare the concentrations of
      these compounds to determine the difference between the two areas. The result can lead to
      further understanding of skin cancers and pre-cancers. Because skin cancers and pre-cancers
      are so common, any knowledge would be very useful for many people in the future and may be
      used for development of future treatments or prevention strategies.
Biopsy procedure will be done at the Beckman Laser Institute or at the Dermatology Clinic
      Gottschalk Medical Plaza, of University of California, Irvine. Standard procedure of punch
      biopsy will be done in the areas determined by the physician researchers. The normal skin
      biopsy will be obtained from an area of skin without any suspicious lesions located on an
      area of the body. Biopsy specimens will be stored frozen at Beckman Laser Institute
      chemistry-lab for research and will be assigned with subject ID number, there will be no
      personnel health information attach to the skin specimens. There will be no cost to the
      subject or their insurer for participation in this study, except in the specific scenario of
      a suspected skin cancer that would undergo biopsy regardless of participation in this study.
      The time commitment for each subject is approximately 1 hour for each set of biopsies.

      Researchers can test the hypothesis that expression of key metabolic enzymes is reduced
      and/or lost during skin cancer progression. Total ribonucleic acid, a single-stranded
      biologic molecule involved in gene transcription, regulation, and translation, can be
      isolated from biopsied skin specimens. Quantitative Real-Time can be performed to determine
      the expression levels of several key metabolic enzymes.

      Metabolic enzymes regulate several vital signaling pathways in the human body. Some examples
      include hormone and bioactive lipid regulation. Aberrant regulation of these signaling
      pathways can lead to human diseases including cancer.

      Recent evidence has shown that metabolic enzyme call UGT in the genes call
      UDP-glucuronosyltransferases were shown to have significantly reduced expression in breast
      tumors compared with normal breast tissue from the same patients This observed loss of
      expression is hypothesized to be causal as these two enzymes are responsible for estrogen
      metabolism.

      However, relatively little is known about metabolic enzymes and skin cancer. We have
      preliminary data that UGT enzyme expression is lost during melanoma progression which allows
      deregulated lipoxygenase signaling.
observational model: Case-Only
time perspective: Prospective
measure: expression levels of metabolic enzymes in normal skin versus precancerous lesions or skin cancer
time frame: 1 month
description: Overall, compare normal skin versus precancerous lesions or skin cancer from the same individual. Paired tests of samples are selected from the same subjects.
10 actinic keratosis samples,
10 basal cell carcinoma samples
20 squamous cell carcinoma samples
Normal skin control biopsy from the same subject will be collected.
arm group label: skin specimen
description: skin specimen
intervention type: Other
intervention name: skin specimen
description: skin specimen
arm group label: skin specimen
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kristen Kelly, MD
role: Principal Investigator
affiliation: Beckman Laser Institute, UCI
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Irvine
investigator full name: Beckman Laser Institute and Medical Center
investigator title: Kirsten Kelly, M.D., Professor of Dermatology and Surgery
mesh term: Skin Neoplasms