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/NCT05965024</url>
    </required_header>
    <id_info>
      <org_study_id>LungMate-016</org_study_id>
      <nct_id>NCT05965024</nct_id>
    </id_info>
    <brief_title>Exploration on the Value of MRD Based on ctDNA Detection in Predicting Recurrence of Resected Non-small Cell Lung Cancer</brief_title>
    <official_title>Exploration on the Value of Molecular Residual Disease Based on Circulating Tumor DNA Detection in Predicting Recurrence of Resected Non-small Cell Lung Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Pulmonary Hospital, Shanghai, China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Pulmonary Hospital, Shanghai, China</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>
        Based on the unique patented MONOD and Methyl Titan methylation sequencing technology on lung&#xD;
        cancer tissue and blood samples, a lung cancer MRD monitoring panel is designed. The panel is&#xD;
        used to detect molecular residual disease of stage IB-IIIB non-small cell lung cancer&#xD;
        patients underwent radical surgery, explore personalized analysis models, and conduct&#xD;
        research on recurrence monitoring for non-small cell lung cancer patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2028</completion_date>
    <primary_completion_date type="Anticipated">August 2026</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>Prospective</time_perspective>
    </study_design_info>
    <target_duration>2 Years</target_duration>
    <primary_outcome>
      <measure>2-year recurrence-free survival rate</measure>
      <time_frame>Up to 24 months</time_frame>
      <description>Recurrence-free survival means the time from the date of surgery to the first recorded date of disease recurrence or patient death, whichever occurs earlier. 2-year recurrence-free survival rate means the rate of patients survive without recurrence for 2 years or more.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Median recurrence-free survival</measure>
      <time_frame>up to 60 months</time_frame>
      <description>Recurrence-free survival means the time from the date of surgery to the first recorded date of disease recurrence or patient death, whichever occurs earlier. Median recurrence-free survival means the median value of recurrence-free survival.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">377</enrollment>
    <condition>Non-small Cell Lung Cancer</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with pathological diagnosis of non-small cell lung cancer and clinical staging of&#xD;
          stage IB-IIIB&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥ 18 years old, regardless of gender;&#xD;
  &#xD;
            2. Patients with pathological diagnosis of non-small cell lung cancer and clinical&#xD;
               staging of stage IB-IIIB;&#xD;
  &#xD;
            3. Able to undergo radical surgical treatment;&#xD;
  &#xD;
            4. Physical condition score (ECOG) ≤1;&#xD;
  &#xD;
            5. The expected survival time exceeds 24 months;&#xD;
  &#xD;
            6. Volunteer to participate in this study and sign an informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Individuals with a history of other malignant tumors within 5 years;&#xD;
  &#xD;
            2. Those who have undergone neoadjuvant therapy before surgery;&#xD;
  &#xD;
            3. Postoperative incision margin R1 or incision margin R2;&#xD;
  &#xD;
            4. Those who have undergone a blood transfusion within 2 weeks before the surgery;&#xD;
  &#xD;
            5. Individuals with systemic inflammatory response syndrome;&#xD;
  &#xD;
            6. Those with serious diseases of important organs such as the heart, lungs, kidneys, and&#xD;
               brain;&#xD;
  &#xD;
            7. Participants in other clinical trials within the past 30 days and have taken&#xD;
               investigational drugs;&#xD;
  &#xD;
            8. Due to various reasons, sampling cannot be completed, samples do not meet the&#xD;
               requirements, or baseline samples (preoperative and postoperative plasma samples,&#xD;
               tumor tissue samples) are incomplete;&#xD;
  &#xD;
            9. Researchers believe that it is not appropriate to participate in this experiment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Shanghai Pulmonary Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200433</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Peng Zhang, PhD</last_name>
        <phone>02165115006</phone>
        <email>zhangpeng1121@tongji.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Shanghai Pulmonary Hospital, Shanghai, China</investigator_affiliation>
      <investigator_full_name>Peng Zhang</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Neoplasms</mesh_term>
      <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
      <mesh_term>Recurrence</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05965024
  org study id: LungMate-016
  nct id: NCT05965024
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Based on the unique patented MONOD and Methyl Titan methylation sequencing technology on lung
        cancer tissue and blood samples, a lung cancer MRD monitoring panel is designed. The panel is
        used to detect molecular residual disease of stage IB-IIIB non-small cell lung cancer
        patients underwent radical surgery, explore personalized analysis models, and conduct
        research on recurrence monitoring for non-small cell lung cancer patients.
  observational model: Cohort
  time perspective: Prospective
  measure: 2-year recurrence-free survival rate
  time frame: Up to 24 months
  description: Recurrence-free survival means the time from the date of surgery to the first recorded date of disease recurrence or patient death, whichever occurs earlier. 2-year recurrence-free survival rate means the rate of patients survive without recurrence for 2 years or more.
  measure: Median recurrence-free survival
  time frame: up to 60 months
  description: Recurrence-free survival means the time from the date of surgery to the first recorded date of disease recurrence or patient death, whichever occurs earlier. Median recurrence-free survival means the median value of recurrence-free survival.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  facility: 
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Shanghai Pulmonary Hospital, Shanghai, China
  investigator full name: Peng Zhang
  investigator title: Professor
  mesh term: Lung Neoplasms
  mesh term: Carcinoma, Non-Small-Cell Lung
  mesh term: Recurrence
  sharing ipd: Undecided