xml: <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/NCT06031337</url>
    </required_header>
    <id_info>
      <org_study_id>1591985</org_study_id>
      <nct_id>NCT06031337</nct_id>
    </id_info>
    <brief_title>Salivary Expression of SOX7 in Oral Squamous Cell Carcinoma: Diagnostic Accuracy Study</brief_title>
    <official_title>Salivary Expression of SOX7 in Oral Squamous Cell Carcinoma: Diagnostic Accuracy Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fayoum University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fayoum University</source>
    <oversight_info>
      <has_dmc>Yes</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 study will include patients with oral cancer and healthy controls of both sexes. Subjects&#xD;
        having any systemic diseases or other types of cancer will be excluded. All subjects will be&#xD;
        selected from Oral Medicine Department, Faculty of Dentistry, Al Ahram Canadian University&#xD;
        and Fayoum University. Informed consent will be obtained from all subjects enrolled in this&#xD;
        study after explanation of the whole procedure.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 3, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 22, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>2 Months</target_duration>
    <primary_outcome>
      <measure>salivary expression of SOX7</measure>
      <time_frame>2 months</time_frame>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">46</enrollment>
    <condition>Oral Cancer</condition>
    <condition>Oral Squamous Cell Carcinoma</condition>
    <arm_group>
      <arm_group_label>Oral Cancer Group</arm_group_label>
      <description>23 patients with oral cancer</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <description>23 age-and-sex-matched healthy individuals, as normal controls</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>ELISA</intervention_name>
      <description>quantitative determination of salivary SOX7 using an Enzyme Linked Immunosorbent assay (ELISA) kit based on the sandwich principle according to the manufacturer's protocol.</description>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_label>Oral Cancer Group</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        saliva&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          23 patients with oral cancer 23 healthy controls&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with oral cancer&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  any systemic diseases or other types of cancer will be excluded&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Fayoum University</name>
        <address>
          <city>Fayoum</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fayoum University</last_name>
        <phone>000201222343488</phone>
        <email>sam24@fayoum.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fayoum University</investigator_affiliation>
      <investigator_full_name>Salsabeel</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Squamous Cell</mesh_term>
      <mesh_term>Mouth Neoplasms</mesh_term>
      <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>on request</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06031337
  org study id: 1591985
  nct id: NCT06031337
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The study will include patients with oral cancer and healthy controls of both sexes. Subjects
        having any systemic diseases or other types of cancer will be excluded. All subjects will be
        selected from Oral Medicine Department, Faculty of Dentistry, Al Ahram Canadian University
        and Fayoum University. Informed consent will be obtained from all subjects enrolled in this
        study after explanation of the whole procedure.
  observational model: Case-Control
  time perspective: Prospective
  measure: salivary expression of SOX7
  time frame: 2 months
  arm group label: Oral Cancer Group
  description: 23 patients with oral cancer
  arm group label: Control Group
  description: 23 age-and-sex-matched healthy individuals, as normal controls
  intervention type: Diagnostic Test
  intervention name: ELISA
  description: quantitative determination of salivary SOX7 using an Enzyme Linked Immunosorbent assay (ELISA) kit based on the sandwich principle according to the manufacturer's protocol.
  arm group label: Control Group
  arm group label: Oral Cancer Group
  saliva
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Fayoum University
  investigator full name: Salsabeel
  investigator title: Lecturer
  mesh term: Carcinoma
  mesh term: Carcinoma, Squamous Cell
  mesh term: Mouth Neoplasms
  mesh term: Squamous Cell Carcinoma of Head and Neck
  sharing ipd: Undecided
  ipd description: on request