<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/NCT03764371</url>
  </required_header>
  <id_info>
    <org_study_id>K2018108</org_study_id>
    <nct_id>NCT03764371</nct_id>
  </id_info>
  <brief_title>Effects of Different Genetic Mutations on Prognosis in sMPLC Adenocarcinoma Patients</brief_title>
  <official_title>A Prospective, Single-center, Phase II Clinical Study of the Effects of Different Genetic Mutations on Prognosis in Multiple Primary Nodular Lung Adenocarcinoma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Hospital of Jilin University</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>
      In 2007 and 2013, the American College of Chest Physicians (ACCP) guidelines applied the&#xD;
      diagnostic criteria of sMPLC （synchronous multiple primary lung cancers）, and the diagnostic&#xD;
      criteria of Martini and Melamed were extended and developed, Summarized as: (1) different&#xD;
      histological types, different genetic characteristics, or different origin of carcinoma in&#xD;
      situ; (2) the histological type is the same, the tumor is located in different lung or&#xD;
      different lung lobes, the common lymphatic drainage site of lung cancer is not cancerous, and&#xD;
      there is no extrapulmonary metastasis at the time of diagnosis.&#xD;
&#xD;
      Postoperative staging of each tumor was carried out in sMPLC patients, if all of them were&#xD;
      stage I lung adenocarcinoma, whether adjuvant therapy could fully refer to the treatment&#xD;
      principle of stage I NSCLC was considered, whether the benefit of subsequent application of&#xD;
      adjuvant chemotherapy was still unclear, and whether adjuvant therapy was needed or not has&#xD;
      been determined.&#xD;
&#xD;
      High-throughput sequencing, also known as &quot;Next generation&quot; sequencing (NGS), is&#xD;
      characterized by sequencing of hundreds of thousands to millions of DNA molecules in&#xD;
      parallel, and generally shorter reads.For multiple tumor lesions resected by sMPLC, only&#xD;
      biopsy gene information from a single cancer focus may not be enough to identify all active&#xD;
      driver gene mutations from the tumor. Therefore, NGS sequencing was proposed for all cancer&#xD;
      lesions of sMPLC patients to reflect the full picture of gene mutation in such patients.&#xD;
&#xD;
      The investigators initiated this prospective clinical study to detect lung cancer related&#xD;
      genes in tumor tissues and patients with at least 2 tumors that were confirmed as invasive&#xD;
      adenocarcinoma by pathology after sMPLC resection (residual non-resectable or non-qualitative&#xD;
      pulmonary nodules). At the same time, application of NGS technology to test lung cancer&#xD;
      related genes in patients' tumor tissues and blood, patients with lung cancer drive genes&#xD;
      were followed up to explore whether different drive genes had an impact on patients' disease&#xD;
      progression. In order to investigate the type of gene that causes disease recurrence in&#xD;
      patients, tissue or blood test was performed again when disease recurrence occur.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 22, 2019</start_date>
  <completion_date type="Anticipated">March 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2022</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>DFS</measure>
    <time_frame>Two years</time_frame>
    <description>Disease-free survival</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Drive-gene about recurrence</measure>
    <time_frame>Five years</time_frame>
    <description>Explore which drive genes are associated with disease recurrence in patients with different drive genes.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Gene Mutation</condition>
  <arm_group>
    <arm_group_label>sMPLC</arm_group_label>
    <description>Lung cancer related genes in tumor tissues and patients with at least 2 tumors that were confirmed as invasive adenocarcinoma by pathology after sMPLC resection (residual non-resectable or non-qualitative pulmonary nodules).</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>KAPA Hyper Prep Kit + Agilent SureSelectQXT</intervention_name>
    <description>We initiated this prospective clinical study to detect lung cancer related genes in tumor tissues and patients with at least 2 tumors that were confirmed as invasive adenocarcinoma by pathology after sMPLC resection (residual non-resectable or non-qualitative pulmonary nodules). At the same time, application of KAPA Hyper Prep Kit + Agilent SureSelectQXT technology to test lung cancer related genes in patients' tumor tissues and blood, patients with lung cancer drive genes were followed up to explore whether different drive genes had an impact on patients' disease progression. In order to investigate the type of gene that causes disease recurrence in patients, tissue or blood test was performed again when disease recurrence occur.</description>
    <arm_group_label>sMPLC</arm_group_label>
    <other_name>NGS technology</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      We use application of NGS technology to test lung cancer related genes in patients' tumor&#xD;
      tissues and blood, patients with lung cancer drive genes were followed up to explore whether&#xD;
      different drive genes had an impact on patients' disease progression.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators initiated this prospective clinical study to detect lung cancer related&#xD;
        genes in tumor tissues and patients with at least 2 tumors that were confirmed as invasive&#xD;
        adenocarcinoma by pathology after sMPLC resection (residual non-resectable or&#xD;
        non-qualitative pulmonary nodules). At the same time, application of NGS technology to test&#xD;
        lung cancer related genes in patients' tumor tissues and blood, patients with lung cancer&#xD;
        drive genes were followed up to explore whether different drive genes had an impact on&#xD;
        patients' disease progression. In order to investigate the type of gene that causes disease&#xD;
        recurrence in patients, tissue or blood test was performed again when disease recurrence&#xD;
        occur.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria：&#xD;
&#xD;
          1. Male or female patients: 18-75 years old;&#xD;
&#xD;
          2. ECOG score: 0-1;&#xD;
&#xD;
          3. At least two tumors in patients with invasive lung adenocarcinoma at stage I are&#xD;
             pathologically confirmed after sMPLC surgery;&#xD;
&#xD;
          4. Genetic test is performed on the pathological tissues of the tumor lesions excised,&#xD;
             and at least one with driver gene;&#xD;
&#xD;
          5. Predicted survival ≥1 year；&#xD;
&#xD;
          6. No more than 3 months after sMPLC surgery (last operation);&#xD;
&#xD;
          7. Good compliance, family members agree to cooperate to receive survival follow-up;&#xD;
&#xD;
          8. Understand and voluntarily sign the informed consent.&#xD;
&#xD;
        Exclusion criteria：&#xD;
&#xD;
          1. Previous or co-existing malignant tumors (patients with resected basal cell carcinoma&#xD;
             or other carcinoma in situ are not included);&#xD;
&#xD;
          2. Systemic anti-tumor therapy, including chemotherapy, radiotherapy or targeted therapy&#xD;
             (including but not limited to monoclonal antibodies, small-molecule tyrosine kinase&#xD;
             inhibitors, etc.) was used before enrollment.&#xD;
&#xD;
          3. Participated in clinical trials of other drugs within 4 weeks&#xD;
&#xD;
          4. All the mutations are insignificant to lung cancer;&#xD;
&#xD;
          5. The investigator is not sure that the subject will be able to complete the study (&#xD;
             management reasons or others).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Kewei F Ma</last_name>
    <phone>008613756060506</phone>
    <email>makw@jlu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ye F Guo</last_name>
    <phone>008615526642279</phone>
    <email>year0904@sina.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The first hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kewei Ma</last_name>
      <phone>13756060506</phone>
      <email>makw@jlu.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>Ye Guo</last_name>
      <phone>15844030579</phone>
      <email>year0904@sina.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>October 12, 2021</last_update_submitted>
  <last_update_submitted_qc>October 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2021</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>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03764371
org study id: K2018108
nct id: NCT03764371
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In 2007 and 2013, the American College of Chest Physicians (ACCP) guidelines applied the
      diagnostic criteria of sMPLC （synchronous multiple primary lung cancers）, and the diagnostic
      criteria of Martini and Melamed were extended and developed, Summarized as: (1) different
      histological types, different genetic characteristics, or different origin of carcinoma in
      situ; (2) the histological type is the same, the tumor is located in different lung or
      different lung lobes, the common lymphatic drainage site of lung cancer is not cancerous, and
      there is no extrapulmonary metastasis at the time of diagnosis.

      Postoperative staging of each tumor was carried out in sMPLC patients, if all of them were
      stage I lung adenocarcinoma, whether adjuvant therapy could fully refer to the treatment
      principle of stage I NSCLC was considered, whether the benefit of subsequent application of
      adjuvant chemotherapy was still unclear, and whether adjuvant therapy was needed or not has
      been determined.

      High-throughput sequencing, also known as "Next generation" sequencing (NGS), is
      characterized by sequencing of hundreds of thousands to millions of DNA molecules in
      parallel, and generally shorter reads.For multiple tumor lesions resected by sMPLC, only
      biopsy gene information from a single cancer focus may not be enough to identify all active
      driver gene mutations from the tumor. Therefore, NGS sequencing was proposed for all cancer
      lesions of sMPLC patients to reflect the full picture of gene mutation in such patients.

      The investigators initiated this prospective clinical study to detect lung cancer related
      genes in tumor tissues and patients with at least 2 tumors that were confirmed as invasive
      adenocarcinoma by pathology after sMPLC resection (residual non-resectable or non-qualitative
      pulmonary nodules). At the same time, application of NGS technology to test lung cancer
      related genes in patients' tumor tissues and blood, patients with lung cancer drive genes
      were followed up to explore whether different drive genes had an impact on patients' disease
      progression. In order to investigate the type of gene that causes disease recurrence in
      patients, tissue or blood test was performed again when disease recurrence occur.
observational model: Cohort
time perspective: Prospective
measure: DFS
time frame: Two years
description: Disease-free survival
measure: Drive-gene about recurrence
time frame: Five years
description: Explore which drive genes are associated with disease recurrence in patients with different drive genes.
arm group label: sMPLC
description: Lung cancer related genes in tumor tissues and patients with at least 2 tumors that were confirmed as invasive adenocarcinoma by pathology after sMPLC resection (residual non-resectable or non-qualitative pulmonary nodules).
intervention type: Diagnostic Test
intervention name: KAPA Hyper Prep Kit + Agilent SureSelectQXT
description: We initiated this prospective clinical study to detect lung cancer related genes in tumor tissues and patients with at least 2 tumors that were confirmed as invasive adenocarcinoma by pathology after sMPLC resection (residual non-resectable or non-qualitative pulmonary nodules). At the same time, application of KAPA Hyper Prep Kit + Agilent SureSelectQXT technology to test lung cancer related genes in patients' tumor tissues and blood, patients with lung cancer drive genes were followed up to explore whether different drive genes had an impact on patients' disease progression. In order to investigate the type of gene that causes disease recurrence in patients, tissue or blood test was performed again when disease recurrence occur.
arm group label: sMPLC
other name: NGS technology
We use application of NGS technology to test lung cancer related genes in patients' tumor
      tissues and blood, patients with lung cancer drive genes were followed up to explore whether
      different drive genes had an impact on patients' disease progression.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Kewei F Ma
phone: 008613756060506
email: makw@jlu.edu.cn
last name: Ye F Guo
phone: 008615526642279
email: year0904@sina.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor
mesh term: Adenocarcinoma