<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/NCT03040492</url>
  </required_header>
  <id_info>
    <org_study_id>X120713008</org_study_id>
    <nct_id>NCT03040492</nct_id>
  </id_info>
  <brief_title>Vitamin D Receptor Polymorphisms and Non-Melanoma Skin Cancer Risk</brief_title>
  <official_title>Vitamin D Receptor Polymorphisms and Non-Melanoma Skin Cancer Risks in Alabama Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to discover whether certain Vitamin D Receptor (VDR) gene&#xD;
      polymorphisms are associated with an increased risk of cutaneous basal cell carcinoma (BCC)&#xD;
      and/or cutaneous squamous cell carcinoma (SCC) in an Alabama population. Participant&#xD;
      demographic information such as physical characteristics (e.g., ethnicity), family history,&#xD;
      and cancer diagnosis will be collected in order to determine if there are relationships&#xD;
      between the gene polymorphisms, cancer diagnosis, and these characteristics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to discover whether certain Vitamin D Receptor (VDR) gene&#xD;
      polymorphisms are associated with an increased risk of cutaneous basal cell carcinoma (BCC)&#xD;
      and/or cutaneous squamous cell carcinoma (SCC) in an Alabama population. Participant&#xD;
      demographic information such as physical characteristics (e.g., ethnicity), family history,&#xD;
      and cancer diagnosis will be collected in order to determine if there are relationships&#xD;
      between the gene polymorphisms, cancer diagnosis, and these characteristics. By identifying&#xD;
      the VDR polymorphisms for the Apa1, Taq1, Bsm1, and Fok1 genes within the participant&#xD;
      population and comparing the genotypes to controls, we hope to demonstrate which gene&#xD;
      polymorphisms indicate an increased risk for SCC or BCC.&#xD;
&#xD;
      Inclusion- patients with a non-melanoma skin cancer. They must be 50 years old or older.&#xD;
      Controls- patients without non-melanoma skin cancer and who have no family history of skin&#xD;
      cancer. They must also be 50 years old or older; Inclusion for both groups- English speakers&#xD;
      and patients at the Kirklin Clinic during the months of our data collection. Exclusion&#xD;
      criteria will be patients younger than 50 years old or who have a diagnosis of melanoma or&#xD;
      other type of cancer, or who are non-English speakers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 31, 2012</start_date>
  <completion_date type="Anticipated">December 6, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2023</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>SIngle nucleotide polymorphisms (SNP)</measure>
    <time_frame>2 years</time_frame>
    <description>Number of patients with the presence or absence of VDR SNP in their DNA isolated from their blood samples. PCR will be performed on the DNA samples for using specific primers for SNP, and the PCR products will be sequenced for detection of SNP.</description>
  </primary_outcome>
  <enrollment type="Actual">200</enrollment>
  <condition>Skin Cancer, Non-Melanoma</condition>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      Biospecimens retained for further analysis of polymorphisms&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The patient group consisted of 100 subjects with a BCC or SCC diagnosis, visiting the&#xD;
        Dermatology Clinics at The Kirklin Clinic at the University of Alabama at Birmingham&#xD;
        between 2012 and 2014&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with non-melanoma skin cancer (cases)&#xD;
&#xD;
          -  Patients without non-melanoma skin cancer or history of non-melanoma skin cancer&#xD;
             (controls)&#xD;
&#xD;
          -  Age 50 and older&#xD;
&#xD;
          -  Native English speakers&#xD;
&#xD;
          -  Patients at Kirklin Clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 50&#xD;
&#xD;
          -  Diagnosis of melanoma or other type of cancer&#xD;
&#xD;
          -  Non-English speakers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Kirklin Clinic</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>August 15, 2023</last_update_submitted>
  <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Nabiha Yusuf</investigator_full_name>
    <investigator_title>Principal Investigator</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03040492
org study id: X120713008
nct id: NCT03040492
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to discover whether certain Vitamin D Receptor (VDR) gene
      polymorphisms are associated with an increased risk of cutaneous basal cell carcinoma (BCC)
      and/or cutaneous squamous cell carcinoma (SCC) in an Alabama population. Participant
      demographic information such as physical characteristics (e.g., ethnicity), family history,
      and cancer diagnosis will be collected in order to determine if there are relationships
      between the gene polymorphisms, cancer diagnosis, and these characteristics.
The purpose of this study is to discover whether certain Vitamin D Receptor (VDR) gene
      polymorphisms are associated with an increased risk of cutaneous basal cell carcinoma (BCC)
      and/or cutaneous squamous cell carcinoma (SCC) in an Alabama population. Participant
      demographic information such as physical characteristics (e.g., ethnicity), family history,
      and cancer diagnosis will be collected in order to determine if there are relationships
      between the gene polymorphisms, cancer diagnosis, and these characteristics. By identifying
      the VDR polymorphisms for the Apa1, Taq1, Bsm1, and Fok1 genes within the participant
      population and comparing the genotypes to controls, we hope to demonstrate which gene
      polymorphisms indicate an increased risk for SCC or BCC.

      Inclusion- patients with a non-melanoma skin cancer. They must be 50 years old or older.
      Controls- patients without non-melanoma skin cancer and who have no family history of skin
      cancer. They must also be 50 years old or older; Inclusion for both groups- English speakers
      and patients at the Kirklin Clinic during the months of our data collection. Exclusion
      criteria will be patients younger than 50 years old or who have a diagnosis of melanoma or
      other type of cancer, or who are non-English speakers.
observational model: Case-Control
time perspective: Cross-Sectional
measure: SIngle nucleotide polymorphisms (SNP)
time frame: 2 years
description: Number of patients with the presence or absence of VDR SNP in their DNA isolated from their blood samples. PCR will be performed on the DNA samples for using specific primers for SNP, and the PCR products will be sequenced for detection of SNP.
Biospecimens retained for further analysis of polymorphisms
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Nabiha Yusuf
investigator title: Principal Investigator
mesh term: Skin Neoplasms
sharing ipd: No