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/NCT05969262</url>
    </required_header>
    <id_info>
      <org_study_id>NFEC-2023-123</org_study_id>
      <nct_id>NCT05969262</nct_id>
    </id_info>
    <brief_title>A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites of Head and Neck Cancer</brief_title>
    <official_title>A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites During the Occurrence and Development of Head and Neck Cancer in Southern China</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nanfang Hospital, Southern Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nanfang Hospital, Southern Medical University</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>
        Dynamic changes in the internal environment of the body are important clues for early&#xD;
        detection, diagnosis and even cure of head and neck tumors. This project uses the combination&#xD;
        of proteomics technology and liquid biopsy to provide more primary prevention strategies for&#xD;
        early intervention, secondary prevention strategies for early detection and treatment, and&#xD;
        clues for the study of the mechanism of dynamic evolution of head and neck tumors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Head and neck cancer is the seventh most common malignant tumor in the world, and China is a&#xD;
        country with a high incidence of head and neck cancer. Dynamic changes in the internal&#xD;
        environment of the body are important clues for early detection, diagnosis and even cure of&#xD;
        head and neck tumors. The occurrence and development of head and neck cancer is complex, so&#xD;
        it is particularly important to explore the changes of internal environment in its clinical&#xD;
        pathway. Therefore, we conducted this study to investigate the changes of plasma and urine&#xD;
        metabolites during the development of head and neck cancer.&#xD;
  &#xD;
        (1) Retrospective cohort: 250 patients were recruited, including 125 patients with Head and&#xD;
        neck cancer and 125 healthy people.,(2) Prospective cohort: 250 patients were recruited,&#xD;
        including 125 head and neck cancer patients and 125 healthy people. During the course of the&#xD;
        study, the subjects will not be given or provided with any randomized or any treatment driven&#xD;
        by the study protocol. If it is clinically applicable, the treatment physician shall make the&#xD;
        treatment decision and choose the treatment plan at his discretion.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 25, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2025</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <target_duration>3 Years</target_duration>
    <primary_outcome>
      <measure>Achieve the expected number of enrolled cases</measure>
      <time_frame>3 years</time_frame>
      <description>Retrospective cohort: 250 patients were recruited, including 125 patients with head and neck cancer, 125 healthy people.&#xD;
  Prospective cohort: 250 patients were recruited, including 125 head and neck cancer patients and 125 healthy people.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Head and Neck Cancer</condition>
    <condition>Metabolite</condition>
    <arm_group>
      <arm_group_label>Head and neck cancer patients</arm_group_label>
      <description>Patients who meet the diagnostic criteria of the Guidelines for Diagnosis and Treatment of Head and Neck Cancer</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy people</arm_group_label>
      <description>Healthy people without liver related medical history or other diseases known to affect blood lipid/protein metabolism.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Proteomics technology and liquid biopsy</intervention_name>
      <description>using proteomics technology and liquid biopsy to investigate the changes of plasma and urine metabolites in different liver diseases during the development of liver cancer by collecting residual blood and urine from routine diagnosis and treatment or physical examination</description>
      <arm_group_label>Head and neck cancer patients</arm_group_label>
      <arm_group_label>Healthy people</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Plasma and Urine&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Subjects who met the diagnosis and criteria of head and neck cancer and were hospitalized&#xD;
          in Southern Hospital of Southern Medical University.Subjects agreed to participate in the&#xD;
          study and signed the informed consent form.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Head and neck cancer patients&#xD;
  &#xD;
                 -  Age 18-75 years old;&#xD;
  &#xD;
                 -  Male or non-pregnant female;&#xD;
  &#xD;
                 -  Patients who were normatively diagnosed as head and neck tumors according to the&#xD;
                    WHO standards of 2017;&#xD;
  &#xD;
                 -  The general situation is good: KPS score ≥70;&#xD;
  &#xD;
                 -  No other malignant tumors.&#xD;
  &#xD;
            2. Healthy people&#xD;
  &#xD;
                 -  Age 18-75 years old;&#xD;
  &#xD;
                 -  Male or non-pregnant female;&#xD;
  &#xD;
                 -  No history of head and neck related diseases or other diseases known to affect&#xD;
                    blood lipid/protein metabolism.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous history of non-research related head and neck conditions or other known&#xD;
               effects on blood metabolism (except for controlled type 2 diabetes);&#xD;
  &#xD;
            -  With a history of other malignancies (except cell carcinoma and cervical carcinoma in&#xD;
               situ);&#xD;
  &#xD;
            -  Diseases that require long-term use of immunosuppressive drugs (including steroids),&#xD;
               including but not limited to congenital or acquired immunodeficiency disorders or&#xD;
               active central nervous system rotations, metastatic cancer, active infection, or&#xD;
               uncontrolled heart disease;&#xD;
  &#xD;
            -  Concurrent with other uncontrolled serious medical conditions, such as unstable heart&#xD;
               disease that requires treatment Disease, poorly controlled diabetes (fasting blood&#xD;
               glucose &gt; 1.5× the upper limit of normal), mental illness and a history of severe&#xD;
               allergies.&#xD;
  &#xD;
            -  BMI less than 18 or greater than 25.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Southern medical university</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510515</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jian Guan, M.D.</last_name>
        <phone>86+13632102247</phone>
        <email>guanjian5461@163.com</email>
      </contact>
      <investigator>
        <last_name>Jian Guan, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</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>Head and Neck Neoplasms</mesh_term>
    </condition_browse>
    <!-- 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/NCT05969262
  org study id: NFEC-2023-123
  nct id: NCT05969262
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Dynamic changes in the internal environment of the body are important clues for early
        detection, diagnosis and even cure of head and neck tumors. This project uses the combination
        of proteomics technology and liquid biopsy to provide more primary prevention strategies for
        early intervention, secondary prevention strategies for early detection and treatment, and
        clues for the study of the mechanism of dynamic evolution of head and neck tumors.
  Head and neck cancer is the seventh most common malignant tumor in the world, and China is a
        country with a high incidence of head and neck cancer. Dynamic changes in the internal
        environment of the body are important clues for early detection, diagnosis and even cure of
        head and neck tumors. The occurrence and development of head and neck cancer is complex, so
        it is particularly important to explore the changes of internal environment in its clinical
        pathway. Therefore, we conducted this study to investigate the changes of plasma and urine
        metabolites during the development of head and neck cancer.
  
        (1) Retrospective cohort: 250 patients were recruited, including 125 patients with Head and
        neck cancer and 125 healthy people.,(2) Prospective cohort: 250 patients were recruited,
        including 125 head and neck cancer patients and 125 healthy people. During the course of the
        study, the subjects will not be given or provided with any randomized or any treatment driven
        by the study protocol. If it is clinically applicable, the treatment physician shall make the
        treatment decision and choose the treatment plan at his discretion.
  observational model: Cohort
  time perspective: Other
  measure: Achieve the expected number of enrolled cases
  time frame: 3 years
  description: Retrospective cohort: 250 patients were recruited, including 125 patients with head and neck cancer, 125 healthy people.
  Prospective cohort: 250 patients were recruited, including 125 head and neck cancer patients and 125 healthy people.
  arm group label: Head and neck cancer patients
  description: Patients who meet the diagnostic criteria of the Guidelines for Diagnosis and Treatment of Head and Neck Cancer
  arm group label: Healthy people
  description: Healthy people without liver related medical history or other diseases known to affect blood lipid/protein metabolism.
  intervention type: Diagnostic Test
  intervention name: Proteomics technology and liquid biopsy
  description: using proteomics technology and liquid biopsy to investigate the changes of plasma and urine metabolites in different liver diseases during the development of liver cancer by collecting residual blood and urine from routine diagnosis and treatment or physical examination
  arm group label: Head and neck cancer patients
  arm group label: Healthy people
  Plasma and Urine
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Sponsor
  mesh term: Head and Neck Neoplasms