<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/NCT02980536</url>
  </required_header>
  <id_info>
    <org_study_id>BerryGenomics NMB</org_study_id>
    <nct_id>NCT02980536</nct_id>
  </id_info>
  <brief_title>cSMART Liquid Biopsy and Dynamic Monitor of NSCLC Patients in Inner-Mongolia China</brief_title>
  <official_title>The Oncogenic Mutation Detection of Advanced NSCLC Patients by cSMART Liquid Biopsy and Dynamic Monitor of Tyrosine Kinase Inhibitor(TKI) Efficiency in Inner-Mongolia China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Berry Genomics Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai Chest Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baotou Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Berry Genomics Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the mutation pattern of epidermal growth factor&#xD;
      receptor (EGFR) and other TKI targeted gene during TKI treatment of advanced NSCLC patient&#xD;
      with liquid biopsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the study, 200 advanced NSCLC patients will be recruited. All the patients will receive&#xD;
      biopsy genotype assay and Circulating Single-Molecule Amplification and Resequencing&#xD;
      Technology (cSMART) liquid biopsy. those patients who carry EGFR activating mutation and&#xD;
      other TKI targeted activating mutation will receive TKI treatment. During the TKI treatment,&#xD;
      every patients will take liquid biopsy assay to monitor the mutation status. the study will&#xD;
      be ended when all the patients had a progressive disease (PD) in their targeted lesion&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">October 2018</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 TKI resistance gene mutation pattern in plasma DNA of TKI treated patient</measure>
    <time_frame>1.5 years</time_frame>
    <description>The researcher would like to find out the change of mutation in plasma DNA of the patients who received TKI treatment by a liquid biopsy method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The concordance of gene mutation pattern between liquid biopsy and traditional cancer tissue biopsy</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">129</enrollment>
  <condition>Nonsmall Cell Lung Cancer</condition>
  <condition>Adenocarcinoma</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      There are two types of biospecimen collected in this study. One is the tumor tissue sample&#xD;
      taken by biopsy. The other is the plasma sample from the blood.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Stage III and Stage IV NSCLC, adenocarcinoma.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  NSCLC adenocarcinoma patients confirmed by pathologist&#xD;
&#xD;
          -  Initial, non-operative patients with stage III &amp; IV adenocarcinoma&#xD;
&#xD;
          -  Older than 18 years old&#xD;
&#xD;
          -  Subjects have no major organ dysfunction. In detail, Liver Function: TBiL≤1.5 ULN (&#xD;
             Upper Limit of Normal); Serum GPT (Glutamate-Pyruvate Transaminase ):≤2 ULN, Renal&#xD;
             Function: ScR≤1.2 ULN; BUN≤1.2 ULN, BM (Bone Marrow) Reserve: WBC (White Blood cell&#xD;
             Count) ≥4.0×e9/L; ANC≥2.0×e9/L，PLT≥100×e9/L，HGB≥100g/L.&#xD;
&#xD;
        PS (Performance Status) Score: less than 2, Expected Survival Time: More than 3 months;&#xD;
&#xD;
          -  Have a clear measurable tumor lesion in lung,under RIEST.&#xD;
&#xD;
          -  Without severe drug allergy&#xD;
&#xD;
          -  Patients participate in this trail must sign the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with brain metases related syndrome&#xD;
&#xD;
          -  Patients with bone metases related complication&#xD;
&#xD;
          -  Patients with cognitive disorder&#xD;
&#xD;
          -  Patients with major organ dysfunction and severe cardiopathy include congestive&#xD;
             heart-failure, uncontrolled arrhythmia, angina with long term treatment, VHD (Valvular&#xD;
             Heart Disease), myocardial infraction, RHTN (Resistant Hypertension).&#xD;
&#xD;
          -  Patients with other severe complication and excluded by the researcher.&#xD;
&#xD;
          -  Patients who are allergy with the TKI in this trail.&#xD;
&#xD;
          -  Patients who participated in other trails or with anti-tumor treatments&#xD;
&#xD;
          -  Patients who receive radiotherapy at the site of curative effect observation&#xD;
&#xD;
          -  Patients who receive allogenic blood transfusion within 14 days&#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>Shun Lu, MD/PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Shanghai Chest Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baogang Hospital</name>
      <address>
        <city>Baotou</city>
        <state>Inner Mongolia</state>
        <zip>014010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baotou Cancer Hospital</name>
      <address>
        <city>Baotou</city>
        <state>Inner Mongolia</state>
        <zip>014030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern Hospital Baotou</name>
      <address>
        <city>Baotou</city>
        <state>Inner Mongolia</state>
        <zip>014030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baotou Centry Hospital</name>
      <address>
        <city>Baotou</city>
        <state>Inner Mongolia</state>
        <zip>014040</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bayan Nur Hospital</name>
      <address>
        <city>Bayan Nur</city>
        <state>Inner Mongolia</state>
        <zip>015000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Inner Mongolia Autonomous Region Cancer Hospital</name>
      <address>
        <city>Hohhot</city>
        <state>Inner Mongolia</state>
        <zip>010017</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Inner Mongolia Autonomous Region People's Hospital</name>
      <address>
        <city>Hohhot</city>
        <state>Inner Mongolia</state>
        <zip>010017</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Inner Monglia Medical University</name>
      <address>
        <city>Hohhot</city>
        <state>Inner Mongolia</state>
        <zip>010050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dalad Banner People's Hospital</name>
      <address>
        <city>Ordos</city>
        <state>Inner Mongolia</state>
        <zip>104300</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Wang Z, Cheng G, Han X, Mu X, Zhang Y, Cui D, Liu C, Zhang L, Fan Z, Ma L, Yang L, Di J, Cram DS, Shi Y, Liu D. Application of Single-Molecule Amplification and Resequencing Technology for Broad Surveillance of Plasma Mutations in Patients with Advanced Lung Adenocarcinoma. J Mol Diagn. 2017 Jan;19(1):169-181. doi: 10.1016/j.jmoldx.2016.09.008. Epub 2016 Nov 19.</citation>
    <PMID>27870944</PMID>
  </reference>
  <reference>
    <citation>Chai X, Ren P, Wei B, Ma J, Mai L, Cram DS, Song Y, Guo Y. A comparative study of EGFR oncogenic mutations in matching tissue and plasma samples from patients with advanced non-small cell lung carcinoma. Clin Chim Acta. 2016 Jun 1;457:106-11. doi: 10.1016/j.cca.2016.04.003. Epub 2016 Apr 9.</citation>
    <PMID>27071701</PMID>
  </reference>
  <reference>
    <citation>Song Y, Zhou X, Huang S, Li X, Qi Q, Jiang Y, Liu Y, Ma C, Li Z, Xu M, Cram DS, Liu J. Quantitation of fetal DNA fraction in maternal plasma using circulating single molecule amplification and re-sequencing technology (cSMART). Clin Chim Acta. 2016 May 1;456:151-156. doi: 10.1016/j.cca.2016.03.005. Epub 2016 Mar 15.</citation>
    <PMID>26993877</PMID>
  </reference>
  <reference>
    <citation>Lv W, Wei X, Guo R, Liu Q, Zheng Y, Chang J, Bai T, Li H, Zhang J, Song Z, Cram DS, Liang D, Wu L. Noninvasive prenatal testing for Wilson disease by use of circulating single-molecule amplification and resequencing technology (cSMART). Clin Chem. 2015 Jan;61(1):172-81. doi: 10.1373/clinchem.2014.229328. Epub 2014 Nov 6.</citation>
    <PMID>25376582</PMID>
  </reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>November 27, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>July 10, 2018</last_update_submitted>
  <last_update_submitted_qc>July 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NSCLC</keyword>
  <keyword>TKI</keyword>
  <keyword>Mutation</keyword>
  <keyword>Liquid Biopsy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Non-Small-Cell Lung</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/NCT02980536
org study id: BerryGenomics NMB
nct id: NCT02980536
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate the mutation pattern of epidermal growth factor
      receptor (EGFR) and other TKI targeted gene during TKI treatment of advanced NSCLC patient
      with liquid biopsy.
In the study, 200 advanced NSCLC patients will be recruited. All the patients will receive
      biopsy genotype assay and Circulating Single-Molecule Amplification and Resequencing
      Technology (cSMART) liquid biopsy. those patients who carry EGFR activating mutation and
      other TKI targeted activating mutation will receive TKI treatment. During the TKI treatment,
      every patients will take liquid biopsy assay to monitor the mutation status. the study will
      be ended when all the patients had a progressive disease (PD) in their targeted lesion
observational model: Cohort
time perspective: Prospective
measure: The TKI resistance gene mutation pattern in plasma DNA of TKI treated patient
time frame: 1.5 years
description: The researcher would like to find out the change of mutation in plasma DNA of the patients who received TKI treatment by a liquid biopsy method.
measure: The concordance of gene mutation pattern between liquid biopsy and traditional cancer tissue biopsy
time frame: 1 year
There are two types of biospecimen collected in this study. One is the tumor tissue sample
      taken by biopsy. The other is the plasma sample from the blood.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shun Lu, MD/PhD
role: Study Chair
affiliation: Shanghai Chest Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
citation: Wang Z, Cheng G, Han X, Mu X, Zhang Y, Cui D, Liu C, Zhang L, Fan Z, Ma L, Yang L, Di J, Cram DS, Shi Y, Liu D. Application of Single-Molecule Amplification and Resequencing Technology for Broad Surveillance of Plasma Mutations in Patients with Advanced Lung Adenocarcinoma. J Mol Diagn. 2017 Jan;19(1):169-181. doi: 10.1016/j.jmoldx.2016.09.008. Epub 2016 Nov 19.
PMID: 27870944
citation: Chai X, Ren P, Wei B, Ma J, Mai L, Cram DS, Song Y, Guo Y. A comparative study of EGFR oncogenic mutations in matching tissue and plasma samples from patients with advanced non-small cell lung carcinoma. Clin Chim Acta. 2016 Jun 1;457:106-11. doi: 10.1016/j.cca.2016.04.003. Epub 2016 Apr 9.
PMID: 27071701
citation: Song Y, Zhou X, Huang S, Li X, Qi Q, Jiang Y, Liu Y, Ma C, Li Z, Xu M, Cram DS, Liu J. Quantitation of fetal DNA fraction in maternal plasma using circulating single molecule amplification and re-sequencing technology (cSMART). Clin Chim Acta. 2016 May 1;456:151-156. doi: 10.1016/j.cca.2016.03.005. Epub 2016 Mar 15.
PMID: 26993877
citation: Lv W, Wei X, Guo R, Liu Q, Zheng Y, Chang J, Bai T, Li H, Zhang J, Song Z, Cram DS, Liang D, Wu L. Noninvasive prenatal testing for Wilson disease by use of circulating single-molecule amplification and resequencing technology (cSMART). Clin Chem. 2015 Jan;61(1):172-81. doi: 10.1373/clinchem.2014.229328. Epub 2014 Nov 6.
PMID: 25376582
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: No