<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/NCT03830619</url>
  </required_header>
  <id_info>
    <org_study_id>WuhanUH2018</org_study_id>
    <nct_id>NCT03830619</nct_id>
  </id_info>
  <brief_title>Serum Exosomal Long Noncoding RNAs as Potential Biomarkers for Lung Cancer Diagnosis</brief_title>
  <official_title>Serum Exosomal Long Noncoding RNAs as Potential Biomarkers for Lung Cancer Diagnosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wuhan Union Hospital, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wuhan Union Hospital, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is to investigate the sensitivity and specificity of serum exosome noncoding RNA as&#xD;
      a biomarker for the diagnosis of lung cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Conventional tumor markers for non-invasive diagnosis of Lung cancer (LC) exhibit&#xD;
      insufficient sensitivity and specificity to facilitate detection of early lung cancer (ELC).&#xD;
      The investigators aimed to identify ELC-specific exosomal lncRNA biomarkers that are highly&#xD;
      sensitive and stable for the non-invasive diagnosis of ELC.Hence, in the present study,&#xD;
      exosomes from the plasma of five healthy individuals and 30 LC patients and from culture&#xD;
      media of four human bronchial epithelial cells and four cancer cells were isolated. Exosomal&#xD;
      RNA profiling was performed using RNA sequencing to identify LC specific exosomal lncRNAs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">July 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The expression levels of serum exosome long non-coding RNA</measure>
    <time_frame>the first day subjects are enrolled the outcome will be assessed；up to three years after the completion of the study</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>the expression levels of tumor biomarkers such as CEA, NSE, SCC, CYFR2A-1</measure>
    <time_frame>the first day subjects are enrolled the outcome will be assessed；up to three years after the completion of the study</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>the CT scans of the lung for the patients</measure>
    <time_frame>the first day subjects are enrolled the outcome will be assessed；up to three years after the completion of the study</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1000</enrollment>
  <condition>Lung Cancer (Diagnosis)</condition>
  <arm_group>
    <arm_group_label>lung cancer patients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>normol volunteers</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>collect samples</intervention_name>
    <description>collect serum samples and clinical features</description>
    <arm_group_label>lung cancer patients</arm_group_label>
    <arm_group_label>normol volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed as lung cancer by histopathology or cytopathology in union hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects are willing to sign the informed consent form;&#xD;
&#xD;
          -  Normal subjects have no evidence of any disease;&#xD;
&#xD;
          -  Lung cancer patients are 18 to 75 years old, diagnosed as lung cancer by&#xD;
             histopathology or cytopathology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  People are unwilling to sign the informed consent form;&#xD;
&#xD;
          -  Patients with heart disease, rheumatic disease, allergic disease, COPD, pulmonary&#xD;
             fibrosis, diabetes, thyroid disease, liver, kidney, brain disease and hematopoietic&#xD;
             system disease;&#xD;
&#xD;
          -  Pregnant or lactating women;&#xD;
&#xD;
          -  Patients did not cooperate or participate in other clinical trials&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Union Hospital, Tongji Medical College, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>February 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>November 15, 2021</last_update_submitted>
  <last_update_submitted_qc>November 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wuhan Union Hospital, China</investigator_affiliation>
    <investigator_full_name>Yang Jin</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>exosomes；lncRNA； lung cancer；</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>no plan to share IPD now</ipd_description>
  </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/NCT03830619
org study id: WuhanUH2018
nct id: NCT03830619
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study is to investigate the sensitivity and specificity of serum exosome noncoding RNA as
      a biomarker for the diagnosis of lung cancer
Conventional tumor markers for non-invasive diagnosis of Lung cancer (LC) exhibit
      insufficient sensitivity and specificity to facilitate detection of early lung cancer (ELC).
      The investigators aimed to identify ELC-specific exosomal lncRNA biomarkers that are highly
      sensitive and stable for the non-invasive diagnosis of ELC.Hence, in the present study,
      exosomes from the plasma of five healthy individuals and 30 LC patients and from culture
      media of four human bronchial epithelial cells and four cancer cells were isolated. Exosomal
      RNA profiling was performed using RNA sequencing to identify LC specific exosomal lncRNAs.
observational model: Cohort
time perspective: Prospective
measure: The expression levels of serum exosome long non-coding RNA
time frame: the first day subjects are enrolled the outcome will be assessed；up to three years after the completion of the study
measure: the expression levels of tumor biomarkers such as CEA, NSE, SCC, CYFR2A-1
time frame: the first day subjects are enrolled the outcome will be assessed；up to three years after the completion of the study
measure: the CT scans of the lung for the patients
time frame: the first day subjects are enrolled the outcome will be assessed；up to three years after the completion of the study
arm group label: lung cancer patients
arm group label: normol volunteers
intervention type: Diagnostic Test
intervention name: collect samples
description: collect serum samples and clinical features
arm group label: lung cancer patients
arm group label: normol volunteers
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Wuhan Union Hospital, China
investigator full name: Yang Jin
investigator title: professor
mesh term: Lung Neoplasms
mesh term: Neoplasms
mesh term: Disease
sharing ipd: No
ipd description: no plan to share IPD now