<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/NCT03002350</url>
  </required_header>
  <id_info>
    <org_study_id>CTCNGS001</org_study_id>
    <secondary_id>MOST-105-2314-B-182A-030 -</secondary_id>
    <nct_id>NCT03002350</nct_id>
  </id_info>
  <brief_title>Clinical Relevance of NGS Analysis for High-purity CTC From Cancer Patients With Disruptive Gene Mutation(s)</brief_title>
  <official_title>Clinical Relevance of Next-generation Sequencing Analysis for High-purity Circulating Tumor Cells From Cancer Patients With Disruptive Gene Mutation(s)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Science and Technology, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Distant metastasis of cancer remains the major cause of cancer death. One of the evidence is&#xD;
      that some rare cells shed from primary tumor exist in the circulation of cancer patients,&#xD;
      which has been proven to be related to cancer relapse and distant metastasis. The number of&#xD;
      circulating tumor cells (CTCs) or the expression status of specific marker(s) on them also&#xD;
      correlated with the disease prognosis and treatment effects, which might change the decision&#xD;
      of treatments. In recent years, as specific disruptive genes were discovered, such as&#xD;
      epidermal growth factor receptor (EGFR) in non-small cell lung cancer,Kirsten rat sarcoma&#xD;
      (KRAS) in colorectal cancer, the response rate to treatment, disease control and survival&#xD;
      have been much improved. However, the molecular information obtained from cancer tissue&#xD;
      depends on repeated biopsies, which is very risky and invasive to cancer patients. By means&#xD;
      of the advances of CTCs sampling technique with genetic analysis, repeated follow-up for&#xD;
      specific gene profiles is possible. However, the protocol has not been well-established and&#xD;
      mature, even the correlation between primary cancer tissue and CTCs remains unknown. To&#xD;
      tackle the problems above, the aims of the project is to isolate high-purity CTCs by the&#xD;
      optically induced dielectrophoresis (ODEP)-based device or other cell sorting techniques and&#xD;
      transfer to next-generation sequencing (NGS) analysis for specific disruptive genes. In the&#xD;
      first year of the project, the investigator will testify and stabilize the platform utilizing&#xD;
      healthy donors' blood and cancer cell lines and adjust the detailed experiment conditions. In&#xD;
      the following year, the investigator will enroll newly diagnosed metastatic cancer patients&#xD;
      with the disruptive gene mutation(s) and follow up the events under gene-based therapy.&#xD;
      Comparison of NGS information between cancer tissue and CTCs will be also made as one of the&#xD;
      major endpoints. In brief, the investigator expect the study could establish a practical&#xD;
      method to get genetic information, to reduce the risk of re-biopsy and to achieve the&#xD;
      ultimate goal of precision medicine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      (A) Establish a High-purity isolation of CTCs to NGS platform within one year&#xD;
&#xD;
      (B) Design a Prospective trial (CTCNGS01 at www.clinicaltrials.gov) utilizing the developed&#xD;
      technique to elucidate the baseline CTC-NGS information to cancer tissue NGS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2016</start_date>
  <completion_date type="Anticipated">November 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2017</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>12 Months</target_duration>
  <primary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>one year</time_frame>
    <description>Measure response or progression events via all available imaging studies, including Chest-Xray, CT scans, or MRI, Positron Emission Tomography(PET)study. The relationship between CTCs number and time from CTCs checkpoint to disease progression will be analyzed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>one year</time_frame>
    <description>All causes of death would be documented and the relationship between CTCs number and time from CTCs checkpoint to death will be analyzed.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Recurrence</condition>
  <condition>Metastasis</condition>
  <condition>Death</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      genomic DNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be conducted in three branch hospitals of Chang Gung Memorial Hospital,&#xD;
        Taiwan including Keelung, Linkou, Taipei. Locally advanced or recurrent/metastatic head and&#xD;
        neck cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        I. Age at diagnosis ≥ 20 years, II. Can fully understand the purpose of the study,&#xD;
        pros/cons of entering the trial with clear and free mind III. With acceptable laboratory&#xD;
        data for receiving anti-cancer therapy, adjusted by clinicians.&#xD;
&#xD;
        IV. Accept all the protocol procedures, including blood sampling and cancer tissue&#xD;
        retrieve.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        I. Refuse to any of study protocol or procedure(s) at any time before or during the trial.&#xD;
&#xD;
        II. Patients without actionable gene alteration or mutation(s) in tissue at screening phase&#xD;
        III. Patients who cannot tolerate anti-cancer therapy for at least 2 months should be&#xD;
        withdrawn IV. Patients who cannot cooperate the imaging study for response evaluation of&#xD;
        anti-cancer therapy V. Patients' tissue is too small to retrieve for NGS analysis. VI.&#xD;
        Difficult blood sampling. VII. Clinician's judgement.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chia-Hsun Hsieh, M.D, M.S</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Linkou</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yo-Ting Hsueh</last_name>
      <phone>03-3196200</phone>
      <phone_ext>3703</phone_ext>
      <email>sally6869@cgmh.org.tw</email>
    </contact>
    <contact_backup>
      <last_name>Chia-Hsun Hsieh, M.D,M.S.</last_name>
      <phone>+886-33281200</phone>
      <phone_ext>8825</phone_ext>
      <email>wisdom5000@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Chia-Hsun Hsieh, M.D, M.S</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Min-Hsien Wu, Ph.D</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hung-Ming Wang, M.D</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yung-Chang Lin, M.D</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tzu-Chen Yen, M.D</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hung-Chih Hsu, M.D</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Jason Chia-Hsun Hsieh</investigator_full_name>
    <investigator_title>Director,Hematology&amp;Oncology, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Circulating tumor cells (CTCs)</keyword>
  <keyword>Optically induced dielectrophoresis (ODEP)</keyword>
  <keyword>Cell sorting</keyword>
  <keyword>Next-generation sequencing (NGS)</keyword>
  <keyword>disruptive mutation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <!-- 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/NCT03002350
org study id: CTCNGS001
secondary id: MOST-105-2314-B-182A-030 -
nct id: NCT03002350
lead sponsor: 
collaborator: 
has dmc: Yes
Distant metastasis of cancer remains the major cause of cancer death. One of the evidence is
      that some rare cells shed from primary tumor exist in the circulation of cancer patients,
      which has been proven to be related to cancer relapse and distant metastasis. The number of
      circulating tumor cells (CTCs) or the expression status of specific marker(s) on them also
      correlated with the disease prognosis and treatment effects, which might change the decision
      of treatments. In recent years, as specific disruptive genes were discovered, such as
      epidermal growth factor receptor (EGFR) in non-small cell lung cancer,Kirsten rat sarcoma
      (KRAS) in colorectal cancer, the response rate to treatment, disease control and survival
      have been much improved. However, the molecular information obtained from cancer tissue
      depends on repeated biopsies, which is very risky and invasive to cancer patients. By means
      of the advances of CTCs sampling technique with genetic analysis, repeated follow-up for
      specific gene profiles is possible. However, the protocol has not been well-established and
      mature, even the correlation between primary cancer tissue and CTCs remains unknown. To
      tackle the problems above, the aims of the project is to isolate high-purity CTCs by the
      optically induced dielectrophoresis (ODEP)-based device or other cell sorting techniques and
      transfer to next-generation sequencing (NGS) analysis for specific disruptive genes. In the
      first year of the project, the investigator will testify and stabilize the platform utilizing
      healthy donors' blood and cancer cell lines and adjust the detailed experiment conditions. In
      the following year, the investigator will enroll newly diagnosed metastatic cancer patients
      with the disruptive gene mutation(s) and follow up the events under gene-based therapy.
      Comparison of NGS information between cancer tissue and CTCs will be also made as one of the
      major endpoints. In brief, the investigator expect the study could establish a practical
      method to get genetic information, to reduce the risk of re-biopsy and to achieve the
      ultimate goal of precision medicine.
(A) Establish a High-purity isolation of CTCs to NGS platform within one year

      (B) Design a Prospective trial (CTCNGS01 at www.clinicaltrials.gov) utilizing the developed
      technique to elucidate the baseline CTC-NGS information to cancer tissue NGS.
observational model: Cohort
time perspective: Prospective
measure: Progression-free survival
time frame: one year
description: Measure response or progression events via all available imaging studies, including Chest-Xray, CT scans, or MRI, Positron Emission Tomography(PET)study. The relationship between CTCs number and time from CTCs checkpoint to disease progression will be analyzed.
measure: Overall survival
time frame: one year
description: All causes of death would be documented and the relationship between CTCs number and time from CTCs checkpoint to death will be analyzed.
genomic DNA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Chia-Hsun Hsieh, M.D, M.S
role: Principal Investigator
affiliation: Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Linkou
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: Jason Chia-Hsun Hsieh
investigator title: Director,Hematology&Oncology, Principal Investigator
mesh term: Recurrence