<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/NCT03234179</url>
  </required_header>
  <id_info>
    <org_study_id>201705110RIND</org_study_id>
    <nct_id>NCT03234179</nct_id>
  </id_info>
  <brief_title>A Prognosis and Predicting Genetic Study of Lung Cancer</brief_title>
  <official_title>A Prognosis and Predicting Genetic Study of Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</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>
      Lung cancer is a leading cause of cancer mortality among adults worldwide. The incidence&#xD;
      rates of lung cancer among never smoking females in some parts of East Asia are among the&#xD;
      highest in the world. The adenocarcinoma of lung being the most frequently identified&#xD;
      histological type is more weakly associated with smoking, and often occurs in females and&#xD;
      never-smokers. Although family history of lung cancer has been associated with histological&#xD;
      subtypes, the inherited susceptibility factors that affect specific histology are unknown.&#xD;
&#xD;
      Genetic factors that determine individual predisposition to lung cancer have been identified&#xD;
      via genome-wide association studies. These known common loci, however, explain only a small&#xD;
      fraction of the familial risk of lung cancer. The hypothesis of this study is that there are&#xD;
      genetic factors that confer inherited susceptibility among patients with primary&#xD;
      non-small-cell lung cancer (NSCLC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To delineate the genetic etiology underlying NSCLC, this study proposes to employ a&#xD;
      family-based linkage analysis, together with rich data generated from NGS, to search for&#xD;
      disease susceptibility locus for the patients with strong family history of primary NSCLC. By&#xD;
      using family pedigrees, linkage analysis will be able to find co-segregation of alleles&#xD;
      through multiple generations at a genetic susceptibility locus and a known genetic marker,&#xD;
      and then the highly penetrate gene loci may be detected by our study. These gene loci will be&#xD;
      a good genetic predictor of NSCLC which should be a great advantage in treatment, prevention&#xD;
      and screening of NSCLC in the future.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">August 1, 2017</start_date>
  <completion_date type="Anticipated">August 1, 2037</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Family-Based</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Genetic information of lung cancer patients</measure>
    <time_frame>One week after the study subjects sign the permit of informed consents</time_frame>
    <description>Collect study subjects' blood sample and analysis with Genome-wide SNP genotyping</description>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Lung Cancer</condition>
  <condition>Genetic Predisposition to Disease</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The samples are stored at the lab of NTUH hospital with protected of security. The&#xD;
      information of the study subjects will be reached only by investigator of this study.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with diagnosis of primary non small cell lung cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patient's family (within third-degree relatives) has at least one diagnosed of&#xD;
             primary non-small cell lung cancer.&#xD;
&#xD;
          2. The patient was diagnosed of primary non-small cell lung cancer at the age &lt; 45 years&#xD;
             old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients without the diagnosis of primary non-small cell lung cancer.&#xD;
&#xD;
          2. Patients who are combined with other malignancy and ongoing chemotherapy / radiation&#xD;
             therapy.&#xD;
&#xD;
          3. Patients combined with coagulopathy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin-Shing Chen, PhD</last_name>
    <role>Study Director</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tung-Ming Tsai, MD</last_name>
    <phone>+886972792011</phone>
    <email>eldorado0607@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jin-Shing Chen, PhD</last_name>
    <phone>+8869721451</phone>
    <email>chenjs@ntu.edu.tw</email>
  </overall_contact_backup>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>July 30, 2017</last_update_submitted>
  <last_update_submitted_qc>July 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Non small cell lung cancer</keyword>
  <keyword>Genetic study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Genetic Predisposition to Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share IPD to other researchers.</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/NCT03234179
org study id: 201705110RIND
nct id: NCT03234179
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Lung cancer is a leading cause of cancer mortality among adults worldwide. The incidence
      rates of lung cancer among never smoking females in some parts of East Asia are among the
      highest in the world. The adenocarcinoma of lung being the most frequently identified
      histological type is more weakly associated with smoking, and often occurs in females and
      never-smokers. Although family history of lung cancer has been associated with histological
      subtypes, the inherited susceptibility factors that affect specific histology are unknown.

      Genetic factors that determine individual predisposition to lung cancer have been identified
      via genome-wide association studies. These known common loci, however, explain only a small
      fraction of the familial risk of lung cancer. The hypothesis of this study is that there are
      genetic factors that confer inherited susceptibility among patients with primary
      non-small-cell lung cancer (NSCLC).
To delineate the genetic etiology underlying NSCLC, this study proposes to employ a
      family-based linkage analysis, together with rich data generated from NGS, to search for
      disease susceptibility locus for the patients with strong family history of primary NSCLC. By
      using family pedigrees, linkage analysis will be able to find co-segregation of alleles
      through multiple generations at a genetic susceptibility locus and a known genetic marker,
      and then the highly penetrate gene loci may be detected by our study. These gene loci will be
      a good genetic predictor of NSCLC which should be a great advantage in treatment, prevention
      and screening of NSCLC in the future.
observational model: Family-Based
time perspective: Prospective
measure: Genetic information of lung cancer patients
time frame: One week after the study subjects sign the permit of informed consents
description: Collect study subjects' blood sample and analysis with Genome-wide SNP genotyping
The samples are stored at the lab of NTUH hospital with protected of security. The
      information of the study subjects will be reached only by investigator of this study.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Jin-Shing Chen, PhD
role: Study Director
affiliation: National Taiwan University Hospital
last name: Tung-Ming Tsai, MD
phone: +886972792011
email: eldorado0607@gmail.com
last name: Jin-Shing Chen, PhD
phone: +8869721451
email: chenjs@ntu.edu.tw
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Genetic Predisposition to Disease
sharing ipd: No
ipd description: No plan to share IPD to other researchers.