<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/NCT03795155</url>
  </required_header>
  <id_info>
    <org_study_id>RenJiH-2018-056</org_study_id>
    <nct_id>NCT03795155</nct_id>
  </id_info>
  <brief_title>Prospective Genomics Initiative on Multiple Synchronous Lung Cancer (PGI-MSLC)</brief_title>
  <official_title>Prospective Genomics Initiative on Multiple Synchronous Lung Cancer (PGI-MSLC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RenJi 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>
      This prospective study is to characterize the genomic landscape and genetic heterogeneity of&#xD;
      multiple synchronous lung cancer (MSLC) in correlation with comprehensive clinical,&#xD;
      histopathological and medical imaging information, in order to improve disease diagnosis and&#xD;
      tailored treatment for MSLC patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  To initiate a prospective registry of MSLC patients with high-quality clinical samples&#xD;
           and detailed medical data.&#xD;
&#xD;
        -  To define the clonal relationship, genomic landscape and potential driver alterations of&#xD;
           MSLC using whole-genome sequencing.&#xD;
&#xD;
        -  To determine the intrapatient and intratumor genetic heterogeneity of MSLC.&#xD;
&#xD;
        -  To correlate molecular features with clinical parameters and patient outcome.&#xD;
&#xD;
        -  To serve as a continuous infrastructure for a large variety of research purposes&#xD;
           including: A. Diagnostic research B. Prognostic research C. Biological research D.&#xD;
           Interventional trial design testing new therapies in MSLC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">November 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 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>Genomic characters of synchronous lessions in each MSLC patient</measure>
    <time_frame>November 30, 2021</time_frame>
    <description>Whole-genome sequencing reveals the mutation, copy number variation and structure variation of MSLCs. We will analysis the genomic characters of synchronous lesions in each MSLC patient.</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Multiple Synchronous Lung Cancers (MSLCs)</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Clinical diagnosis of multiple synchronous lung cancers (MSLCs)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Confirmed diagnosis of multiple synchronous lung cancers (MSLCs) without metastatic&#xD;
             disease&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical or psychiatric condition that would preclude informed consent&#xD;
&#xD;
          -  History of known high-risk infections&#xD;
&#xD;
          -  With metastatic tumors except lung&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaojing Zhao, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ren Ji Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yujie Fu, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ren Ji Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guanglei Zhuang, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ren Ji Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pengfei Ma, Ph.D.</last_name>
    <phone>+8613671806647</phone>
    <email>pengfei0820@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pengfei Ma, Ph.D.</last_name>
      <phone>+8613671806647</phone>
      <email>pengfei0820@163.com</email>
    </contact>
    <investigator>
      <last_name>Xiaojing Zhao, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yujie Fu, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Guanglei Zhuang, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Ma P, Fu Y, Cai MC, Yan Y, Jing Y, Zhang S, Chen M, Wu J, Shen Y, Zhu L, Chen HZ, Gao WQ, Wang M, Gu Z, Bivona TG, Zhao X, Zhuang G. Simultaneous evolutionary expansion and constraint of genomic heterogeneity in multifocal lung cancer. Nat Commun. 2017 Oct 10;8(1):823. doi: 10.1038/s41467-017-00963-0.</citation>
    <PMID>29018192</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</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>Lung Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03795155
org study id: RenJiH-2018-056
nct id: NCT03795155
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This prospective study is to characterize the genomic landscape and genetic heterogeneity of
      multiple synchronous lung cancer (MSLC) in correlation with comprehensive clinical,
      histopathological and medical imaging information, in order to improve disease diagnosis and
      tailored treatment for MSLC patients.
-  To initiate a prospective registry of MSLC patients with high-quality clinical samples
           and detailed medical data.

        -  To define the clonal relationship, genomic landscape and potential driver alterations of
           MSLC using whole-genome sequencing.

        -  To determine the intrapatient and intratumor genetic heterogeneity of MSLC.

        -  To correlate molecular features with clinical parameters and patient outcome.

        -  To serve as a continuous infrastructure for a large variety of research purposes
           including: A. Diagnostic research B. Prognostic research C. Biological research D.
           Interventional trial design testing new therapies in MSLC.
observational model: Cohort
time perspective: Prospective
measure: Genomic characters of synchronous lessions in each MSLC patient
time frame: November 30, 2021
description: Whole-genome sequencing reveals the mutation, copy number variation and structure variation of MSLCs. We will analysis the genomic characters of synchronous lesions in each MSLC patient.
tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xiaojing Zhao, M.D.
role: Principal Investigator
affiliation: Ren Ji Hospital
last name: Yujie Fu, Ph.D.
role: Principal Investigator
affiliation: Ren Ji Hospital
last name: Guanglei Zhuang, Ph.D.
role: Principal Investigator
affiliation: Ren Ji Hospital
last name: Pengfei Ma, Ph.D.
phone: +8613671806647
email: pengfei0820@163.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: China
citation: Ma P, Fu Y, Cai MC, Yan Y, Jing Y, Zhang S, Chen M, Wu J, Shen Y, Zhu L, Chen HZ, Gao WQ, Wang M, Gu Z, Bivona TG, Zhao X, Zhuang G. Simultaneous evolutionary expansion and constraint of genomic heterogeneity in multifocal lung cancer. Nat Commun. 2017 Oct 10;8(1):823. doi: 10.1038/s41467-017-00963-0.
PMID: 29018192
responsible party type: Sponsor
mesh term: Lung Neoplasms
sharing ipd: No