<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/NCT03029065</url>
  </required_header>
  <id_info>
    <org_study_id>ShandongCHI004</org_study_id>
    <nct_id>NCT03029065</nct_id>
  </id_info>
  <brief_title>Detection of CSF Next Generation Sequencing in the Application of Brain Metastases From Lung Adenocarcinoma or Meningeal Metastasis</brief_title>
  <acronym>CSF</acronym>
  <official_title>Detection of CSF Next Generation Sequencing in the Application of Brain Metastases From Lung Adenocarcinoma or Meningeal Metastasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong Cancer Hospital and Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shandong Cancer Hospital and Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to detect cell free DNA (cfDNA) in the cerebrospinal fluid and plasma, and&#xD;
      to determine whether cfDNA can be used for concomitant diagnosis to improve the treatment&#xD;
      efficacy and prognosis of patients with brain (meningeal) metastasis by monitoring&#xD;
      tumor-related genetic mutations in cfDNA in the plasma and cerebrospinal fluid.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study planned to enroll 50 patients with lung cancer diagnosed with brain (meningeal)&#xD;
      metastases, and all cases were slated to receive radiotherapy and targeted therapy. Patients'&#xD;
      clinical data were collected (including but not limited to: age at diagnosis with brain&#xD;
      (meningeal) metastases, KPS score, smoking history, stage of disease at diagnosis, time to&#xD;
      progress to brain metastases, number of brain metastases, extracranial metastases (ECM), and&#xD;
      systemic disease at the time of brain metastases. Anticoagulated whole blood and&#xD;
      anticoagulated cerebrospinal fluid were collected before local treatment (samples of primary&#xD;
      cancer tissue and metastatic carcinoma of some patients were preserved) and at 7 days, 1&#xD;
      month, 3 months, as well as 6 months after the treatment (time of sample retention was to be&#xD;
      determined, Figure 2). DNA was extracted from tumor tissues, genomic DNA was extracted from&#xD;
      leukocytes, and cfDNA was extracted from plasma and cerebrospinal fluid, for complete&#xD;
      quantitative detection of DNA, DNA library construction, as well as targeted capture&#xD;
      sequencing. Tumor-related genes were analyzed, and changes in the tumor burden during the&#xD;
      treatment process were evaluated. The clinical significance of cfDNA in the plasma and&#xD;
      cerebrospinal fluid for treatment efficacy and prognosis was evaluated, and compared with&#xD;
      that of clinical indicators of treatment efficacy.&#xD;
&#xD;
      This study involved two stages. The first stage was a pre-experiment: samples were retained&#xD;
      from 3-5 cases, and mutations in tumor-related genes in the cfDNA in plasma and cerebrospinal&#xD;
      fluid were compared. The investigators analyzed, combined with clinical indicators, whether&#xD;
      mutations of cfDNA in plasma accord with that of the cerebrospinal fluid and whether&#xD;
      mutations of cfDNA in cerebrospinal can reflect the mutational status of tumor cells. The&#xD;
      second phase was conducted by expanding the number of cases, based on the first stage.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>investigate new diagnosis method for lung adenocarcinoma with brain (meningeal) metastasis</measure>
    <time_frame>Participants are followed in 6 months after treatment</time_frame>
    <description>Investigate whether the cfDNA can be used for concomitant diagnosis to improve the treatment efficacy and prognosis of patients with brain (meningeal) metastasis by monitoring tumor-related genetic mutations in cfDNA in the plasma and cerebrospinal fluid.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Recruitment</condition>
  <arm_group>
    <arm_group_label>lung adenocarcinoma with brain (meningeal) metastasis</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Anticoagulated whole blood, anticoagulated cerebrospinal fluid and tumor tissue were&#xD;
      collected. DNA was extracted from tumor tissues, genomic DNA was extracted from leukocytes,&#xD;
      and cfDNA was extracted from plasma and cerebrospinal fluid.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Ages Eligible for Study: 18 Years and older (Adult, Senior) Sexes Eligible for Study: All&#xD;
        Accepts Healthy Volunteers: No&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with confirmed diagnosis of lung adenocarcinoma with brain (meningeal)&#xD;
             metastasis.&#xD;
&#xD;
          2. Samples collection should be allowed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant women&#xD;
&#xD;
          2. Minors (subjects less than 18 years of age)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Yong Wang, PhD</last_name>
    <phone>13365318361</phone>
    <email>doctorwy@163.com</email>
  </overall_contact>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>January 23, 2017</last_update_submitted>
  <last_update_submitted_qc>January 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong Cancer Hospital and Institute</investigator_affiliation>
    <investigator_full_name>Rongjie Tao</investigator_full_name>
    <investigator_title>Shandong Cancer Hospital and Institute</investigator_title>
  </responsible_party>
  <keyword>lung Adenocarcinoma with brain (meningeal) metastasis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Brain Neoplasms</mesh_term>
    <mesh_term>Adenocarcinoma of 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/NCT03029065
org study id: ShandongCHI004
nct id: NCT03029065
lead sponsor: 
has dmc: Yes
This study aimed to detect cell free DNA (cfDNA) in the cerebrospinal fluid and plasma, and
      to determine whether cfDNA can be used for concomitant diagnosis to improve the treatment
      efficacy and prognosis of patients with brain (meningeal) metastasis by monitoring
      tumor-related genetic mutations in cfDNA in the plasma and cerebrospinal fluid.
This study planned to enroll 50 patients with lung cancer diagnosed with brain (meningeal)
      metastases, and all cases were slated to receive radiotherapy and targeted therapy. Patients'
      clinical data were collected (including but not limited to: age at diagnosis with brain
      (meningeal) metastases, KPS score, smoking history, stage of disease at diagnosis, time to
      progress to brain metastases, number of brain metastases, extracranial metastases (ECM), and
      systemic disease at the time of brain metastases. Anticoagulated whole blood and
      anticoagulated cerebrospinal fluid were collected before local treatment (samples of primary
      cancer tissue and metastatic carcinoma of some patients were preserved) and at 7 days, 1
      month, 3 months, as well as 6 months after the treatment (time of sample retention was to be
      determined, Figure 2). DNA was extracted from tumor tissues, genomic DNA was extracted from
      leukocytes, and cfDNA was extracted from plasma and cerebrospinal fluid, for complete
      quantitative detection of DNA, DNA library construction, as well as targeted capture
      sequencing. Tumor-related genes were analyzed, and changes in the tumor burden during the
      treatment process were evaluated. The clinical significance of cfDNA in the plasma and
      cerebrospinal fluid for treatment efficacy and prognosis was evaluated, and compared with
      that of clinical indicators of treatment efficacy.

      This study involved two stages. The first stage was a pre-experiment: samples were retained
      from 3-5 cases, and mutations in tumor-related genes in the cfDNA in plasma and cerebrospinal
      fluid were compared. The investigators analyzed, combined with clinical indicators, whether
      mutations of cfDNA in plasma accord with that of the cerebrospinal fluid and whether
      mutations of cfDNA in cerebrospinal can reflect the mutational status of tumor cells. The
      second phase was conducted by expanding the number of cases, based on the first stage.
observational model: Cohort
time perspective: Prospective
measure: investigate new diagnosis method for lung adenocarcinoma with brain (meningeal) metastasis
time frame: Participants are followed in 6 months after treatment
description: Investigate whether the cfDNA can be used for concomitant diagnosis to improve the treatment efficacy and prognosis of patients with brain (meningeal) metastasis by monitoring tumor-related genetic mutations in cfDNA in the plasma and cerebrospinal fluid.
arm group label: lung adenocarcinoma with brain (meningeal) metastasis
Anticoagulated whole blood, anticoagulated cerebrospinal fluid and tumor tissue were
      collected. DNA was extracted from tumor tissues, genomic DNA was extracted from leukocytes,
      and cfDNA was extracted from plasma and cerebrospinal fluid.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Yong Wang, PhD
phone: 13365318361
email: doctorwy@163.com
responsible party type: Principal Investigator
investigator affiliation: Shandong Cancer Hospital and Institute
investigator full name: Rongjie Tao
investigator title: Shandong Cancer Hospital and Institute
mesh term: Adenocarcinoma
mesh term: Neoplasm Metastasis
mesh term: Brain Neoplasms
mesh term: Adenocarcinoma of Lung
sharing ipd: No