<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/NCT03838588</url>
  </required_header>
  <id_info>
    <org_study_id>T-MENC-NSCLC</org_study_id>
    <nct_id>NCT03838588</nct_id>
  </id_info>
  <brief_title>The Tracking Molecular Evolution for NSCLC (T-MENC) Study</brief_title>
  <official_title>Tracking Genomic Cancer Evolution in Patients for Stage IB,II and IIIA Non-small Cell Lung Cancer After Radical Resection: The Tracking Molecular Evolution for NSCLC (T-MENC) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Geneplus-Beijing Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Xuanwu Hospital, Beijing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Geneplus-Beijing Co. Ltd.</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>
      Tumor genomic clonal evolution assessed with liquid biopsy of stage IB,II and IIIA non-small&#xD;
      cell lung cancer patients after getting radical resection. Plasma circulating tumor DNA&#xD;
      (ctDNA) analysis detects molecule residual disease and predicts recurrence in patients. The&#xD;
      concordance of the relative abundance of mutations in plasma ctDNA with cancer recurrence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the study, 200 of stage IB,II and IIIA non-small cell lung cancer patients obtained&#xD;
      radical resection will be recruited. All the patients will receive biopsy genotype assay and&#xD;
      ctDNA liquid biopsy. The abundance of mutations of ctDNA was tracked at 4 time points,&#xD;
      including:&#xD;
&#xD;
        1. st: 10 Days after patients received radical resection.&#xD;
&#xD;
        2. nd: When patients finished the chemotherapy or target drug delivery two cycles.&#xD;
&#xD;
        3. rd: 10 Days after patients finished the chemotherapy or target drug delivery four&#xD;
           cycles.&#xD;
&#xD;
        4. th: When tumor recrudescence / 2 years after radical resection.&#xD;
&#xD;
      Tumor genomic clonal evolution was assessed by analyzing the relative abundance of mutations&#xD;
      in plasma circulating tumor DNA (ctDNA).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 6, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>Tumor genomic clonal evolution assessed with liquid biopsy of stage IB,II and IIIA non-small cell lung cancer patients after getting radical resection.</measure>
    <time_frame>From assignment of the first subject to the time point when tumor recrudescence or 2 years after radical resection. The last participant will be recruited before June 30,2021.</time_frame>
    <description>The tumor molecular clones and the frequency of gene mutations from 1021 tumor related genes will be detected by next-generation sequencing, which will be matched with the CT scanning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The concordance of the plasma ctDNA detection status with Progress Free Survival (PFS) and Overall Survival (OS) after radical resection or/and under adjuvant therapy.</measure>
    <time_frame>From assignment of the first subject to the time point when tumor recrudescence or 2 years after radical resection. The last participant will be recruited before June 30, 2021.</time_frame>
    <description>Plasma circulating tumor DNA (ctDNA) analysis detects molecule residual disease and predicts recurrence in patients. All the patients will receive biopsy genotype assay and ctDNA liquid biopsy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of ctDNA detecting assay in monitoring recurrence of early stage of lung cancer after radical resection.</measure>
    <time_frame>From assignment of the first subject to the time point when tumor recrudescence or 2 years after radical resection. The last participant will be recruited before June 30, 2021.</time_frame>
    <description>All the patients will receive biopsy genotype assay and ctDNA liquid biopsy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The molecular mechanism between the tumor recurrence and ctDNA mutations</measure>
    <time_frame>From assignment of the first subject to the time point when tumor recrudescence or 2 years after radical resection. The last participant will be recruited before June 30, 2021.</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Lung Neoplasms</condition>
  <condition>Lung Cancer</condition>
  <condition>Nonsmall Cell Lung Cancer</condition>
  <condition>Adenocarcinoma of Lung</condition>
  <arm_group>
    <arm_group_label>T-MENC Study Group</arm_group_label>
    <description>In the study, 200 of stage IB,II and IIIA non-small cell lung cancer patients obtained radical resection will be recruited. All the patients will receive biopsy genotype assay and ctDNA liquid biopsy. The abundance of mutations of ctDNA was tracked at 4 time points, including:&#xD;
st: 10 Days after patients received radical resection.&#xD;
nd: When patients finished the chemotherapy or target drug delivery two cycles.&#xD;
rd: 10 Days after patients finished the chemotherapy or target drug delivery four cycles.&#xD;
th: When tumor recrudescence / 2 years after radical resection. Tumor genomic clonal evolution was assessed by analyzing the relative abundance of mutations in plasma circulating tumor DNA (ctDNA).</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood (including plasma, white cells), tissue.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Tracking Genomic Cancer Evolution in Patients for Stage IB,II and IIIA Non-small Cell Lung&#xD;
        Cancer After Radical Resection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of informed consent and assigned.&#xD;
&#xD;
          2. Newly diagnosed and histological or cytological confirmed stage IB-IIIA lung&#xD;
             adenocarcinoma or non-smoking squamous cell carcinoma patients according to the AJCC&#xD;
             staging system.&#xD;
&#xD;
          3. Expected radical resection.&#xD;
&#xD;
          4. Patients expected more than 3 months of survival time.&#xD;
&#xD;
          5. Willingness to comply with required protocols and give permission to use the data for&#xD;
             clinical research and products development.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who want Neo-adjuvant therapy.&#xD;
&#xD;
          2. Patients with T3-4N1 Pancoast tumors (superior sulcal tumors).&#xD;
&#xD;
          3. Multi-station N2 non-small cell lung cancer with lymph node metastasis.&#xD;
&#xD;
          4. Eastern cooperative oncology group (ECOG) performance status &gt; 2 after postoperative&#xD;
             chemotherapy&#xD;
&#xD;
          5. Eastern cooperative oncology group (ECOG) performance status &gt; 4 after postoperative&#xD;
             targeted therapy.&#xD;
&#xD;
          6. Patients must never ever has received for any history of radiotherapy/&#xD;
             chemotherapy/surgery before.&#xD;
&#xD;
          7. Patients have other primary cancers.&#xD;
&#xD;
          8. Known central nervous system metastasis.&#xD;
&#xD;
          9. Patients expected less than 3 months of survival time.&#xD;
&#xD;
         10. Other situations mismatch this program.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yi Zhang, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Xuanwu Hospital, Beijing</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yao guang Sun, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jie Li, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China +86-139 1189 2587 lijie821cn@163.com</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hong Zhang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Hospital of Jilin University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zhi qiang Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tangshan People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ming He, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Chest Hospital, Capital Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zi dan Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Chest Hospital, Capital Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Li jun Liu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hebei General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kang Shao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chao yang Liang</last_name>
    <role>Principal Investigator</role>
    <affiliation>China-Japan Friendship Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yi Zhang, MD</last_name>
    <phone>+86-13141370703</phone>
    <email>steven9130@sina.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100005</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yao Guang Sun, MD</last_name>
      <phone>+86-13601310875</phone>
      <email>sunyaoguang@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cancer Hospital Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kang Shao, MD</last_name>
      <phone>+86-13901191120</phone>
      <email>13901191120@139.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>China-Japan Friendship Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chao yang Liang, MD</last_name>
      <phone>+86-18610570066</phone>
      <email>chaoyangliang@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Friendship Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jie Li, MD</last_name>
      <phone>+86-13911892587</phone>
      <email>lijie821cn@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xuanwu Hospital Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yi Zhang, MD</last_name>
      <phone>+86-13141370703</phone>
      <email>steven9130@sina.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Chest Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>101149</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zi dan Wang, MD</last_name>
      <phone>+86-13501272331</phone>
      <email>wztdoctor@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fourth Hospital of Hebei Medical University</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ming He, MD</last_name>
      <phone>+86-13833187902</phone>
      <email>heming6699@sina.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hebei General Hospital</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050051</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Li jun Liu, MD</last_name>
      <phone>+86-13833131067</phone>
      <email>13833131067@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tangshan People's Hospital</name>
      <address>
        <city>Tangshan</city>
        <state>Hebei</state>
        <zip>063001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhi qiang Wang, MD</last_name>
      <phone>+86-13333299798</phone>
      <email>737703213@qq.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Bethune Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hong Zhang, MD</last_name>
      <phone>+86-13514468707</phone>
      <email>yveszhang@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Bettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126/scitranslmed.3007094.</citation>
    <PMID>24553385</PMID>
  </results_reference>
  <results_reference>
    <citation>Tie J, Wang Y, Tomasetti C, Li L, Springer S, Kinde I, Silliman N, Tacey M, Wong HL, Christie M, Kosmider S, Skinner I, Wong R, Steel M, Tran B, Desai J, Jones I, Haydon A, Hayes T, Price TJ, Strausberg RL, Diaz LA Jr, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Sci Transl Med. 2016 Jul 6;8(346):346ra92. doi: 10.1126/scitranslmed.aaf6219.</citation>
    <PMID>27384348</PMID>
  </results_reference>
  <results_reference>
    <citation>Abbosh C, Birkbak NJ, Wilson GA, Jamal-Hanjani M, Constantin T, Salari R, Le Quesne J, Moore DA, Veeriah S, Rosenthal R, Marafioti T, Kirkizlar E, Watkins TBK, McGranahan N, Ward S, Martinson L, Riley J, Fraioli F, Al Bakir M, Gronroos E, Zambrana F, Endozo R, Bi WL, Fennessy FM, Sponer N, Johnson D, Laycock J, Shafi S, Czyzewska-Khan J, Rowan A, Chambers T, Matthews N, Turajlic S, Hiley C, Lee SM, Forster MD, Ahmad T, Falzon M, Borg E, Lawrence D, Hayward M, Kolvekar S, Panagiotopoulos N, Janes SM, Thakrar R, Ahmed A, Blackhall F, Summers Y, Hafez D, Naik A, Ganguly A, Kareht S, Shah R, Joseph L, Marie Quinn A, Crosbie PA, Naidu B, Middleton G, Langman G, Trotter S, Nicolson M, Remmen H, Kerr K, Chetty M, Gomersall L, Fennell DA, Nakas A, Rathinam S, Anand G, Khan S, Russell P, Ezhil V, Ismail B, Irvin-Sellers M, Prakash V, Lester JF, Kornaszewska M, Attanoos R, Adams H, Davies H, Oukrif D, Akarca AU, Hartley JA, Lowe HL, Lock S, Iles N, Bell H, Ngai Y, Elgar G, Szallasi Z, Schwarz RF, Herrero J, Stewart A, Quezada SA, Peggs KS, Van Loo P, Dive C, Lin CJ, Rabinowitz M, Aerts HJWL, Hackshaw A, Shaw JA, Zimmermann BG; TRACERx consortium; PEACE consortium; Swanton C. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017 Apr 26;545(7655):446-451. doi: 10.1038/nature22364. Erratum In: Nature. 2017 Dec 20;:</citation>
    <PMID>28445469</PMID>
  </results_reference>
  <results_reference>
    <citation>Chaudhuri AA, Chabon JJ, Lovejoy AF, Newman AM, Stehr H, Azad TD, Khodadoust MS, Esfahani MS, Liu CL, Zhou L, Scherer F, Kurtz DM, Say C, Carter JN, Merriott DJ, Dudley JC, Binkley MS, Modlin L, Padda SK, Gensheimer MF, West RB, Shrager JB, Neal JW, Wakelee HA, Loo BW Jr, Alizadeh AA, Diehn M. Early Detection of Molecular Residual Disease in Localized Lung Cancer by Circulating Tumor DNA Profiling. Cancer Discov. 2017 Dec;7(12):1394-1403. doi: 10.1158/2159-8290.CD-17-0716. Epub 2017 Sep 24.</citation>
    <PMID>28899864</PMID>
  </results_reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 10, 2019</study_first_submitted>
  <study_first_submitted_qc>February 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 10, 2019</last_update_submitted>
  <last_update_submitted_qc>February 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</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>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Adenocarcinoma of Lung</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>May 30, 2019</submitted>
    <returned>August 1, 2019</returned>
  </pending_results>
  <!-- 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/NCT03838588
org study id: T-MENC-NSCLC
nct id: NCT03838588
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Tumor genomic clonal evolution assessed with liquid biopsy of stage IB,II and IIIA non-small
      cell lung cancer patients after getting radical resection. Plasma circulating tumor DNA
      (ctDNA) analysis detects molecule residual disease and predicts recurrence in patients. The
      concordance of the relative abundance of mutations in plasma ctDNA with cancer recurrence.
In the study, 200 of stage IB,II and IIIA non-small cell lung cancer patients obtained
      radical resection will be recruited. All the patients will receive biopsy genotype assay and
      ctDNA liquid biopsy. The abundance of mutations of ctDNA was tracked at 4 time points,
      including:

        1. st: 10 Days after patients received radical resection.

        2. nd: When patients finished the chemotherapy or target drug delivery two cycles.

        3. rd: 10 Days after patients finished the chemotherapy or target drug delivery four
           cycles.

        4. th: When tumor recrudescence / 2 years after radical resection.

      Tumor genomic clonal evolution was assessed by analyzing the relative abundance of mutations
      in plasma circulating tumor DNA (ctDNA).
observational model: Cohort
time perspective: Prospective
measure: Tumor genomic clonal evolution assessed with liquid biopsy of stage IB,II and IIIA non-small cell lung cancer patients after getting radical resection.
time frame: From assignment of the first subject to the time point when tumor recrudescence or 2 years after radical resection. The last participant will be recruited before June 30,2021.
description: The tumor molecular clones and the frequency of gene mutations from 1021 tumor related genes will be detected by next-generation sequencing, which will be matched with the CT scanning.
measure: The concordance of the plasma ctDNA detection status with Progress Free Survival (PFS) and Overall Survival (OS) after radical resection or/and under adjuvant therapy.
time frame: From assignment of the first subject to the time point when tumor recrudescence or 2 years after radical resection. The last participant will be recruited before June 30, 2021.
description: Plasma circulating tumor DNA (ctDNA) analysis detects molecule residual disease and predicts recurrence in patients. All the patients will receive biopsy genotype assay and ctDNA liquid biopsy.
measure: Evaluation of ctDNA detecting assay in monitoring recurrence of early stage of lung cancer after radical resection.
time frame: From assignment of the first subject to the time point when tumor recrudescence or 2 years after radical resection. The last participant will be recruited before June 30, 2021.
description: All the patients will receive biopsy genotype assay and ctDNA liquid biopsy.
measure: The molecular mechanism between the tumor recurrence and ctDNA mutations
time frame: From assignment of the first subject to the time point when tumor recrudescence or 2 years after radical resection. The last participant will be recruited before June 30, 2021.
arm group label: T-MENC Study Group
description: In the study, 200 of stage IB,II and IIIA non-small cell lung cancer patients obtained radical resection will be recruited. All the patients will receive biopsy genotype assay and ctDNA liquid biopsy. The abundance of mutations of ctDNA was tracked at 4 time points, including:
st: 10 Days after patients received radical resection.
nd: When patients finished the chemotherapy or target drug delivery two cycles.
rd: 10 Days after patients finished the chemotherapy or target drug delivery four cycles.
th: When tumor recrudescence / 2 years after radical resection. Tumor genomic clonal evolution was assessed by analyzing the relative abundance of mutations in plasma circulating tumor DNA (ctDNA).
Whole blood (including plasma, white cells), tissue.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yi Zhang, MD
role: Study Chair
affiliation: Xuanwu Hospital, Beijing
last name: Yao guang Sun, MD
role: Principal Investigator
affiliation: Beijing Hospital
last name: Jie Li, MD
role: Principal Investigator
affiliation: Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China +86-139 1189 2587 lijie821cn@163.com
last name: Hong Zhang, MD
role: Principal Investigator
affiliation: The First Hospital of Jilin University
last name: Zhi qiang Wang, MD
role: Principal Investigator
affiliation: Tangshan People's Hospital
last name: Ming He, MD
role: Principal Investigator
affiliation: Beijing Chest Hospital, Capital Medical University
last name: Zi dan Wang, MD
role: Principal Investigator
affiliation: Beijing Chest Hospital, Capital Medical University
last name: Li jun Liu, MD
role: Principal Investigator
affiliation: Hebei General Hospital
last name: Kang Shao, MD
role: Principal Investigator
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
last name: Chao yang Liang
role: Principal Investigator
affiliation: China-Japan Friendship Hospital
last name: Yi Zhang, MD
phone: +86-13141370703
email: steven9130@sina.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
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status: Recruiting
contact: 
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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country: China
citation: Bettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126/scitranslmed.3007094.
PMID: 24553385
citation: Tie J, Wang Y, Tomasetti C, Li L, Springer S, Kinde I, Silliman N, Tacey M, Wong HL, Christie M, Kosmider S, Skinner I, Wong R, Steel M, Tran B, Desai J, Jones I, Haydon A, Hayes T, Price TJ, Strausberg RL, Diaz LA Jr, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Sci Transl Med. 2016 Jul 6;8(346):346ra92. doi: 10.1126/scitranslmed.aaf6219.
PMID: 27384348
citation: Abbosh C, Birkbak NJ, Wilson GA, Jamal-Hanjani M, Constantin T, Salari R, Le Quesne J, Moore DA, Veeriah S, Rosenthal R, Marafioti T, Kirkizlar E, Watkins TBK, McGranahan N, Ward S, Martinson L, Riley J, Fraioli F, Al Bakir M, Gronroos E, Zambrana F, Endozo R, Bi WL, Fennessy FM, Sponer N, Johnson D, Laycock J, Shafi S, Czyzewska-Khan J, Rowan A, Chambers T, Matthews N, Turajlic S, Hiley C, Lee SM, Forster MD, Ahmad T, Falzon M, Borg E, Lawrence D, Hayward M, Kolvekar S, Panagiotopoulos N, Janes SM, Thakrar R, Ahmed A, Blackhall F, Summers Y, Hafez D, Naik A, Ganguly A, Kareht S, Shah R, Joseph L, Marie Quinn A, Crosbie PA, Naidu B, Middleton G, Langman G, Trotter S, Nicolson M, Remmen H, Kerr K, Chetty M, Gomersall L, Fennell DA, Nakas A, Rathinam S, Anand G, Khan S, Russell P, Ezhil V, Ismail B, Irvin-Sellers M, Prakash V, Lester JF, Kornaszewska M, Attanoos R, Adams H, Davies H, Oukrif D, Akarca AU, Hartley JA, Lowe HL, Lock S, Iles N, Bell H, Ngai Y, Elgar G, Szallasi Z, Schwarz RF, Herrero J, Stewart A, Quezada SA, Peggs KS, Van Loo P, Dive C, Lin CJ, Rabinowitz M, Aerts HJWL, Hackshaw A, Shaw JA, Zimmermann BG; TRACERx consortium; PEACE consortium; Swanton C. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017 Apr 26;545(7655):446-451. doi: 10.1038/nature22364. Erratum In: Nature. 2017 Dec 20;:
PMID: 28445469
citation: Chaudhuri AA, Chabon JJ, Lovejoy AF, Newman AM, Stehr H, Azad TD, Khodadoust MS, Esfahani MS, Liu CL, Zhou L, Scherer F, Kurtz DM, Say C, Carter JN, Merriott DJ, Dudley JC, Binkley MS, Modlin L, Padda SK, Gensheimer MF, West RB, Shrager JB, Neal JW, Wakelee HA, Loo BW Jr, Alizadeh AA, Diehn M. Early Detection of Molecular Residual Disease in Localized Lung Cancer by Circulating Tumor DNA Profiling. Cancer Discov. 2017 Dec;7(12):1394-1403. doi: 10.1158/2159-8290.CD-17-0716. Epub 2017 Sep 24.
PMID: 28899864
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Adenocarcinoma of Lung
sharing ipd: No
submitted: May 30, 2019
returned: August 1, 2019