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/NCT05984017</url>
    </required_header>
    <id_info>
      <org_study_id>SHR-1701 RWS</org_study_id>
      <nct_id>NCT05984017</nct_id>
    </id_info>
    <brief_title>A Non-interventional Study With Advanced Lung Squamous Cell Carcinoma</brief_title>
    <official_title>A Non-interventional Study and Its Clinical Relevance With Advanced Lung Squamous Cell Carcinoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hunan Province Tumor Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hunan Province Tumor Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a descriptive observational study, in which data are collected in an epidemiological&#xD;
        fashion and prospective. This study does not intend to intervene the current medical practice&#xD;
        of the recruited patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 10, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>progression-free survival</measure>
      <time_frame>2 years</time_frame>
      <description>From registration onto that step until death, or censored at the date of last contact.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Overall survival</measure>
      <time_frame>2 years</time_frame>
      <description>From registration onto that step until death, or censored at the date of last contact.</description>
    </primary_outcome>
    <enrollment type="Anticipated">130</enrollment>
    <condition>Advanced Lung Squamous Cell Carcinoma</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No treatment is included in this study</intervention_name>
      <description>No drug intervention or tissue sampling will be included in this study.</description>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        needle biopsy for samples with DNA&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          advanced or metastatic (stage IV) lung squamous cell carcinoma&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients must be ≥18 years.&#xD;
  &#xD;
            -  Provision of fully informed consent prior to any study specific procedures.&#xD;
  &#xD;
            -  Advanced or metastatic lung squamous cell carcinoma confirmed by histology or&#xD;
               cytology.&#xD;
  &#xD;
            -  According to the RECIST 1.1 standard, the patient must have at least one measurable&#xD;
               lesion.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  None&#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>Yongchang Zhang, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hunan Cancer Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yongchang C Zhang, MD</last_name>
      <phone>+8613873123436</phone>
      <phone_ext>7+861383123436</phone_ext>
      <email>zhangyongchang@csu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nong Yang, MD</last_name>
      <phone>+8613055193557</phone>
      <phone_ext>+8613873123436</phone_ext>
      <email>yangnong0217@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Yongchang Zhang</name>
        <address>
          <city>Changsha</city>
          <state>Hunan</state>
          <zip>410013</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yongchang Yongchang Zhang, MD</last_name>
        <phone>+8613873123436</phone>
        <phone_ext>+8613873123436</phone_ext>
        <email>zhangyongchang@csu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hunan Province Tumor Hospital</investigator_affiliation>
      <investigator_full_name>Yongchang Zhang</investigator_full_name>
      <investigator_title>Professor, Deputy Director of Thoracic Oncology Department</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>
    </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/NCT05984017
  org study id: SHR-1701 RWS
  nct id: NCT05984017
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a descriptive observational study, in which data are collected in an epidemiological
        fashion and prospective. This study does not intend to intervene the current medical practice
        of the recruited patients.
  observational model: Cohort
  time perspective: Prospective
  measure: progression-free survival
  time frame: 2 years
  description: From registration onto that step until death, or censored at the date of last contact.
  measure: Overall survival
  time frame: 2 years
  description: From registration onto that step until death, or censored at the date of last contact.
  intervention type: Other
  intervention name: No treatment is included in this study
  description: No drug intervention or tissue sampling will be included in this study.
  needle biopsy for samples with DNA
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yongchang Zhang, MD
  role: Principal Investigator
  affiliation: Hunan Cancer Hospital
  last name: Yongchang C Zhang, MD
  phone: +8613873123436
  phone ext: 7+861383123436
  email: zhangyongchang@csu.edu.cn
  last name: Nong Yang, MD
  phone: +8613055193557
  phone ext: +8613873123436
  email: yangnong0217@163.com
  facility: 
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Hunan Province Tumor Hospital
  investigator full name: Yongchang Zhang
  investigator title: Professor, Deputy Director of Thoracic Oncology Department
  mesh term: Carcinoma
  mesh term: Carcinoma, Squamous Cell