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/NCT05983835</url>
    </required_header>
    <id_info>
      <org_study_id>Union-01</org_study_id>
      <nct_id>NCT05983835</nct_id>
    </id_info>
    <brief_title>Combined Segmentectomy Versus Lobectomy for Stage IA Lung Adenocarcinoma With Ground-glass Component of Prospective, Randomized, Controlled Clinical Study</brief_title>
    <official_title>Combined Segmentectomy Versus Lobectomy for Stage IA Lung Adenocarcinoma With Ground-glass Component of Prospective, Randomized, Controlled Clinical Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fujian Medical University Union Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Wu Jieping Medical Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Fujian Medical University Union 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 project intends to include stage IA lung adenocarcinoma patients with CT imaging&#xD;
        grboreal lesions; compare the results of lobectomy vs combined subsegmentectomy, and compare&#xD;
        perioperative complications, differences in lung function and long-term outcomes between the&#xD;
        two groups.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">October 1, 2022</start_date>
    <completion_date type="Anticipated">October 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Disease-Free Survival</measure>
      <time_frame>2 years</time_frame>
      <description>This is the time from the time of surgery until the patient's tumor recurred, metastasized, or died</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">688</enrollment>
    <condition>IA Lung Adenocarcinoma</condition>
    <condition>Combined Segmentectomy</condition>
    <arm_group>
      <arm_group_label>combined segmentectomy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>lobectomy</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Patients receive subsegmentectomy</intervention_name>
      <description>Patients receive lobectomy</description>
      <arm_group_label>combined segmentectomy</arm_group_label>
      <arm_group_label>lobectomy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  (1)Age: 20-80 years, (2)suspected non-small-cell lung carcinoma, mixed nodules with&#xD;
               GGO in the middle and peripheral lung fields, (3) clinical stage (UICC Stage 8) ,&#xD;
               Stage IA (T1a-cN0M0) , (4) multiple GGO was considered to be multiple primary lung&#xD;
               cancer, but the largest diameter of GGO was less than 3 cm, the largest diameter of&#xD;
               compactness was less than 2 cm, the largest diameter of GGO was less than 3 cm, the&#xD;
               largest diameter of compactness was less than 2 cm, the largest diameter of GGO was&#xD;
               less than 3 cm, the largest diameter of compactness was less than 2 cm (5) without any&#xD;
               induction therapy; (6) PS score of 0-1, without severe complications, and functional&#xD;
               status tolerant to minimally invasive lobectomy.&#xD;
  &#xD;
               (7) FEV1≥1L was assessed by pulmonary function test and was greater than 50% of the&#xD;
               predicted value, (8) no hilar and mediastinal lymph node metastasis and no distant&#xD;
               metastasis were found in the preoperative clinical evaluation, (9) voluntary&#xD;
               participation and informed consent were obtained;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  (1) pure dense nodules without GGO, or pure GGO ≤0.5 cm with GGO;(2) the lesion was&#xD;
               located in 1/3 of the lung field, and combined segmental resection may not meet the&#xD;
               requirement of resection margin (3) multiple GGO considered multiple primary lung&#xD;
               cancer with the largest diameter ≥1cm, dense component ≥0.5 cm and a second primary&#xD;
               lesion that may require surgical treatment in the next 5 years (4) high risk patients&#xD;
               with severe other organ diseases, (5) history of other malignant tumors within 5&#xD;
               years, (6) history of ipsilateral thoracic surgery. (7) the lesion was located in the&#xD;
               middle lobe of the right lung, (8) in pregnant or lactating women, (9) with severe&#xD;
               mental disorders, (10) with a history of unstable angina or myocardial infarction&#xD;
               within 6 months, and severe stenosis of the major branches of the coronary artery;&#xD;
               (11) a history of cerebral infarction or cerebral hemorrhage within 6 months, (12) a&#xD;
               history of continuous systemic corticosteroid therapy within 1 month, and (13)&#xD;
               according to the judgment of the investigators, the patients were not suitable to be&#xD;
               included in the trial.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Fujian Medical University Union Hospital</name>
        <address>
          <city>Fuzhou</city>
          <zip>350001</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>October 2022</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 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 9, 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>Adenocarcinoma</mesh_term>
      <mesh_term>Adenocarcinoma of Lung</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/NCT05983835
  org study id: Union-01
  nct id: NCT05983835
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This project intends to include stage IA lung adenocarcinoma patients with CT imaging
        grboreal lesions; compare the results of lobectomy vs combined subsegmentectomy, and compare
        perioperative complications, differences in lung function and long-term outcomes between the
        two groups.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Disease-Free Survival
  time frame: 2 years
  description: This is the time from the time of surgery until the patient's tumor recurred, metastasized, or died
  arm group label: combined segmentectomy
  arm group type: Experimental
  arm group label: lobectomy
  arm group type: Placebo Comparator
  intervention type: Procedure
  intervention name: Patients receive subsegmentectomy
  description: Patients receive lobectomy
  arm group label: combined segmentectomy
  arm group label: lobectomy
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 80 Years
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Adenocarcinoma
  mesh term: Adenocarcinoma of Lung