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/NCT05979623</url>
    </required_header>
    <id_info>
      <org_study_id>B2021-128</org_study_id>
      <nct_id>NCT05979623</nct_id>
    </id_info>
    <brief_title>Clinicopathological Characteristics and Prognosis Analysis of Stage IB Non-small Cell Lung Cancer</brief_title>
    <official_title>Clinicopathological Characteristics and Prognosis Analysis of Stage IB Non-small Cell Lung Cancer：A Retrospective Real World Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Zhongshan Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Zhongshan 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>
        The goal of this observation study is to learn about clinicopathological characteristics and&#xD;
        prognostic factors of stage IB NSCLC. The main question it aims to answer is wheather there&#xD;
        is relationship between newly proposed clinicopathological features and the prognosis of&#xD;
        stage IB NSCLC .The postoperative pathological and follow-up information of participants will&#xD;
        be used for subsequent analysis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A total of 971 NSCLC patients with pathological stage IB resected by surgery (R0) from&#xD;
        January 2016 to December 2020 at Zhongshan Hospital of Fudan University were reviewed. The&#xD;
        primary endpoint is RFS (recurrence-free survival) and OS (overall survival) is the secondary&#xD;
        endpoint. The baseline characteristics of the patients were obtained statistically, and&#xD;
        factors affecting the prognosis of patients with stage IB NSCLC were analyzed using survival&#xD;
        analysis and Cox proportional hazard models. The characteristics of the patients include&#xD;
        pathological type, STAS, GGO, gene mutation, and postoperative adjuvant chemotherapy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 2016</start_date>
    <completion_date type="Actual">December 2022</completion_date>
    <primary_completion_date type="Actual">December 2020</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>RFS</measure>
      <time_frame>5 years</time_frame>
      <description>recurrence-free survival</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>OS</measure>
      <time_frame>5 years</time_frame>
      <description>overall survival</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">971</enrollment>
    <condition>Stage IB Non-Small Cell Lung Carcinoma</condition>
    <arm_group>
      <arm_group_label>ZS-IB-NSCLC</arm_group_label>
      <description>A total of 971 NSCLC patients with pathological stage IB resected by surgery (R0) from January 2016 to December 2020 at Zhongshan Hospital of Fudan University</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          NSCLC patients with pathological stage IB resected by surgery (R0)&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  It was confirmed by histopathology as primary non-small cell lung cancer, and the&#xD;
               pathological type was LUSC or LUAD;&#xD;
  &#xD;
            -  According to the 8th edition of TNM clinical staging standards, it is determined as IB&#xD;
               stage&#xD;
  &#xD;
            -  No treatment was performed for the primary lesion of lung cancer before surgery;&#xD;
  &#xD;
            -  No history of other malignant tumors before surgery;&#xD;
  &#xD;
            -  Detailed clinical and pathological information, complete survival data, and no missing&#xD;
               follow-up data.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The postoperative histopathological types include non-scale and non adenocarcinoma,&#xD;
               such as lung adenosquamous cell carcinoma, large cell lung cancer, or lung sarcomatoid&#xD;
               carcinoma;&#xD;
  &#xD;
            -  Multiple lesion staging surgery;&#xD;
  &#xD;
            -  History of merging with other malignant tumors&#xD;
  &#xD;
            -  Having preoperative treatment;&#xD;
  &#xD;
            -  Missing follow-up information.&#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>Di Ge, Ph.D;M.D</last_name>
      <role>Study Chair</role>
      <affiliation>Zhongshan Hospital, Fudan University, Shanghai, China</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>180 Fenglin Road</name>
        <address>
          <city>Shanghai</city>
          <zip>200032</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 29, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 29, 2023</last_update_submitted>
    <last_update_submitted_qc>July 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 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>Carcinoma, Non-Small-Cell Lung</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05979623
  org study id: B2021-128
  nct id: NCT05979623
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observation study is to learn about clinicopathological characteristics and
        prognostic factors of stage IB NSCLC. The main question it aims to answer is wheather there
        is relationship between newly proposed clinicopathological features and the prognosis of
        stage IB NSCLC .The postoperative pathological and follow-up information of participants will
        be used for subsequent analysis.
  A total of 971 NSCLC patients with pathological stage IB resected by surgery (R0) from
        January 2016 to December 2020 at Zhongshan Hospital of Fudan University were reviewed. The
        primary endpoint is RFS (recurrence-free survival) and OS (overall survival) is the secondary
        endpoint. The baseline characteristics of the patients were obtained statistically, and
        factors affecting the prognosis of patients with stage IB NSCLC were analyzed using survival
        analysis and Cox proportional hazard models. The characteristics of the patients include
        pathological type, STAS, GGO, gene mutation, and postoperative adjuvant chemotherapy.
  observational model: Cohort
  time perspective: Retrospective
  measure: RFS
  time frame: 5 years
  description: recurrence-free survival
  measure: OS
  time frame: 5 years
  description: overall survival
  arm group label: ZS-IB-NSCLC
  description: A total of 971 NSCLC patients with pathological stage IB resected by surgery (R0) from January 2016 to December 2020 at Zhongshan Hospital of Fudan University
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Di Ge, Ph.D;M.D
  role: Study Chair
  affiliation: Zhongshan Hospital, Fudan University, Shanghai, China
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Carcinoma, Non-Small-Cell Lung
  sharing ipd: No