<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/NCT03790735</url>
  </required_header>
  <id_info>
    <org_study_id>TianjinCIH2018</org_study_id>
    <nct_id>NCT03790735</nct_id>
  </id_info>
  <brief_title>The MDA Test to Differentiate of Benign and Malignant Pulmonary Nodules</brief_title>
  <official_title>Targeted Chromosomal Aberrations Detection by FISH Analysis of Circulating Abnormal Cells to Differentiate of Benign and Malignant Pulmonary Nodules</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Medical University Cancer Institute and Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zhuhai livzon cynvenio diagnostics LTD</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tianjin Medical University Cancer Institute and 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 purpose of the study is the identification of the efficacy of MDA Test to&#xD;
           Differentiate of Benign and Malignant Pulmonary Nodules.&#xD;
&#xD;
        -  In this study, the investigators are going to validate the efficacy of the MDA test for&#xD;
           diagnosing early lung cancer by comparing results of the pre-surgery MDA test with the&#xD;
           post-surgery pathology.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Current state-of-the-art lung cancer early screening utilizes low-dose CT scan to&#xD;
           identify lung nodules smaller than 3 cm in diameter. However, it's still a clinical&#xD;
           challenge to differentiate between malignant and benign nodules.&#xD;
&#xD;
        -  This study is being conducted to evaluate the efficacy of the MDA TEST to detect&#xD;
           Targeted chromosomal aberrations in circulating abnormal cells by FISH analysis that&#xD;
           might be an early indicator of lung cancer. Approximately 200 Pre-surgery adult patients&#xD;
           with single pulmonary nodule found by CT scan, will be enrolled in the study. The sample&#xD;
           type of MDA test is Peripheral Blood. This study will compare the results of the&#xD;
           pre-surgery MDA Test with the post-surgery pathology to determine if the test can detect&#xD;
           lung cancer or the lack of lung cancer .&#xD;
&#xD;
        -  The results of the test will not be provided to the subject, the investigator and will&#xD;
           not be used to diagnose or treat the subject.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 3, 2018</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">March 2019</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Early detection of lung cancer</measure>
    <time_frame>6 months</time_frame>
    <description>The efficacy of the MDA TEST assay comparing with pathologic diagnosis(the gold standard), and CT/LDCT diagnosis, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Pulmonary Nodule, Solitary</condition>
  <arm_group>
    <arm_group_label>Diagnostic test</arm_group_label>
    <description>Targeted chromosomal aberrations detection by FISH (MDA TEST).</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>FISH</intervention_name>
    <description>Targeted chromosomal aberrations detection</description>
    <arm_group_label>Diagnostic test</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        200 participants&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years old or above&#xD;
&#xD;
          -  single pulmonary nodule found by CT scan.&#xD;
&#xD;
          -  the diameter of the pulmonary nodule is between 5mm to 30mm.&#xD;
&#xD;
          -  plan to accept pneumonectomy due to the pulmonary nodule.&#xD;
&#xD;
          -  agree to sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  fail to understand or agree to sign informed consent.&#xD;
&#xD;
          -  pregnant or lactating women.&#xD;
&#xD;
          -  the diameter of the pulmonary nodule is more than 30mm.&#xD;
&#xD;
          -  there are 2 or more pulmonary nodules in one single patient.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Changli Wang, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tianjin Medical University Cancer Institute &amp; Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dongyan Cheng</last_name>
    <phone>(022)23340123-6012</phone>
    <phone_ext>(022)23524155</phone_ext>
    <email>chengdongyan916@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute &amp; Hospital</name>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dongyan Cheng</last_name>
      <phone>(022)23340123-6012</phone>
      <phone_ext>(022)23524155</phone_ext>
      <email>chengdongyan916@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>December 31, 2018</last_update_submitted>
  <last_update_submitted_qc>December 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pulmonary nodule</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Pulmonary Nodules</mesh_term>
    <mesh_term>Solitary Pulmonary Nodule</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03790735
org study id: TianjinCIH2018
nct id: NCT03790735
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
-  The purpose of the study is the identification of the efficacy of MDA Test to
           Differentiate of Benign and Malignant Pulmonary Nodules.

        -  In this study, the investigators are going to validate the efficacy of the MDA test for
           diagnosing early lung cancer by comparing results of the pre-surgery MDA test with the
           post-surgery pathology.
-  Current state-of-the-art lung cancer early screening utilizes low-dose CT scan to
           identify lung nodules smaller than 3 cm in diameter. However, it's still a clinical
           challenge to differentiate between malignant and benign nodules.

        -  This study is being conducted to evaluate the efficacy of the MDA TEST to detect
           Targeted chromosomal aberrations in circulating abnormal cells by FISH analysis that
           might be an early indicator of lung cancer. Approximately 200 Pre-surgery adult patients
           with single pulmonary nodule found by CT scan, will be enrolled in the study. The sample
           type of MDA test is Peripheral Blood. This study will compare the results of the
           pre-surgery MDA Test with the post-surgery pathology to determine if the test can detect
           lung cancer or the lack of lung cancer .

        -  The results of the test will not be provided to the subject, the investigator and will
           not be used to diagnose or treat the subject.
observational model: Cohort
time perspective: Cross-Sectional
measure: Early detection of lung cancer
time frame: 6 months
description: The efficacy of the MDA TEST assay comparing with pathologic diagnosis(the gold standard), and CT/LDCT diagnosis, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).
arm group label: Diagnostic test
description: Targeted chromosomal aberrations detection by FISH (MDA TEST).
intervention type: Diagnostic Test
intervention name: FISH
description: Targeted chromosomal aberrations detection
arm group label: Diagnostic test
whole blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Changli Wang, Prof
role: Principal Investigator
affiliation: Tianjin Medical University Cancer Institute & Hospital
last name: Dongyan Cheng
phone: (022)23340123-6012
phone ext: (022)23524155
email: chengdongyan916@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Multiple Pulmonary Nodules
mesh term: Solitary Pulmonary Nodule
sharing ipd: Undecided