<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/NCT03772496</url>
  </required_header>
  <id_info>
    <org_study_id>S0006YIO</org_study_id>
    <nct_id>NCT03772496</nct_id>
  </id_info>
  <brief_title>Diagnostic Significance of CTCs in Patients With Thyroid Nodules (Circulating Tumor Cells)</brief_title>
  <acronym>CTCs</acronym>
  <official_title>A Multicenter, Double-blind, Prospective Cohort Study of Diagnostic Significance of Circulating Tumor Cells in Patients With Thyroid Nodules</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>China-Japan Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Chao Yang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Thyroid nodule patients with suggestion of fine needle aspiration biopsy (FNAB) offered by&#xD;
      ultrasound are enrolled in the study. CTCs tested by Optimizing method and FNAB will be&#xD;
      performed simultaneously. This is a double blind trial which pathologists and inspectors of&#xD;
      CTCs don't know the result of each other. Surgical pathology and diagnostic results of FNAB&#xD;
      is the primary endpoint and comparison will be made to see if CTCs combined with ultrasound&#xD;
      can get similar diagnostic performance as FNAB. The diagnostic results of FNAB included&#xD;
      Bethesda class II and more than V which are defined as benign and malignant, respectively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Some retrospective analysises showed CTCs is considered to be valuable for diagnosis,&#xD;
      staging, prognosis and follow-up in several types of cancers and some mRNA markers are&#xD;
      helpful in differentiating patients with benign versus malignant thyroid disease. However,&#xD;
      the lack of sensitivity and specificity of mRNA measurements restricted their clinical&#xD;
      application. The aim of this study is to see if optimizing test method combined with&#xD;
      ultrasound can get similar diagnostic performance. 200 patients with thyroid nodules (≤2cm)&#xD;
      which need to undergo FNAB will be enrolled in four centers of northern China. Patients will&#xD;
      simultaneously undergo CTCs tests and FNAB. And following treatments will be performed&#xD;
      according to the previous standard. Allowed by the patients, the investigators will obtain&#xD;
      10ml peripheral blood samples from the participants to make a CTCs test before any FNAB. The&#xD;
      primary end point is the pathologically confirmed benign versus malignant thyroid disease,&#xD;
      which including surgical pathology and diagnostic results of FNAB.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 25, 2018</start_date>
  <completion_date type="Anticipated">February 20, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 20, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>post-operative pathology</measure>
    <time_frame>10 days after surgery</time_frame>
    <description>Patients with malignant results of FNAB (Bethesda V and VI)non-diagnostic results of FNAB (Bethesda class I , III, IV)will be suggested to undergo surgery. Those patients who underwent surgery are enrolled in our study and are performed a post-operative pathology, which have a higher evidence rank than FNAB. According to post-operative pathology, any type of thyroid carcinoma is defined as malignant, and patients who have not been strong enough to be diagnosed with carcinoma is defined as benign disease.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>diagnostic results of FNAB</measure>
    <time_frame>10 days after FNAB</time_frame>
    <description>The result of FNAB are classified by Bethesda rating system. Bethesda class I is considered the sample is not qualified, Bethesda class II is defined as benign, Bethesda class III and IV are defined as non-diagnostic result, which need further verified by surgery.Bethesda class V and VI are defined as malignant.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Thyroid Nodule</condition>
  <condition>Diagnoses Disease</condition>
  <arm_group>
    <arm_group_label>circulating tumor cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>circulating tumor cells test and FNAB will be performed at the same time</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>circulating tumor cells test</intervention_name>
    <description>10 ml Peripheral blood are drawn from patients enrolled before surgery/FNAB and centrifuged to collect the peripheral blood mononuclear cells. Then, negative and positive immunomagnetic selections are used to exclude white blood cells and enrich tumor cells. After isolating mRNA, RT-PCR array is used to measure expression of target genes.</description>
    <arm_group_label>circulating tumor cells</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Fine needle aspiration biopsy</intervention_name>
    <description>patients with potential malignant thyroid nodules are performed fine needle aspiration biopsy with the aid of ultrasound. The result of FNAB were classified by Bethesda rating system.</description>
    <arm_group_label>circulating tumor cells</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with thyroid nodules (≤2cm) untreatment FNAB suggested by ultrasound&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the history of other cancer the history of thyroid surgery Bethesda class 3 without&#xD;
             surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>jie liu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Hospital, Chinese Academy of Medical Science</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>jie liu, MD</last_name>
    <phone>8610-87787180</phone>
    <email>liujie10-11@vip.163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cancer Hospital, Chinese Academy of Medical Science</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>jie liu, MD</last_name>
      <phone>8610-87787180</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>September 14, 2019</last_update_submitted>
  <last_update_submitted_qc>September 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>liu jie</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>fine needle aspiration biopsy</keyword>
  <keyword>Circulating tumor cells</keyword>
  <keyword>benign</keyword>
  <keyword>malignant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplastic Cells, Circulating</mesh_term>
    <mesh_term>Thyroid Nodule</mesh_term>
    <mesh_term>Thyroid Diseases</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/NCT03772496
org study id: S0006YIO
nct id: NCT03772496
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Thyroid nodule patients with suggestion of fine needle aspiration biopsy (FNAB) offered by
      ultrasound are enrolled in the study. CTCs tested by Optimizing method and FNAB will be
      performed simultaneously. This is a double blind trial which pathologists and inspectors of
      CTCs don't know the result of each other. Surgical pathology and diagnostic results of FNAB
      is the primary endpoint and comparison will be made to see if CTCs combined with ultrasound
      can get similar diagnostic performance as FNAB. The diagnostic results of FNAB included
      Bethesda class II and more than V which are defined as benign and malignant, respectively.
Some retrospective analysises showed CTCs is considered to be valuable for diagnosis,
      staging, prognosis and follow-up in several types of cancers and some mRNA markers are
      helpful in differentiating patients with benign versus malignant thyroid disease. However,
      the lack of sensitivity and specificity of mRNA measurements restricted their clinical
      application. The aim of this study is to see if optimizing test method combined with
      ultrasound can get similar diagnostic performance. 200 patients with thyroid nodules (≤2cm)
      which need to undergo FNAB will be enrolled in four centers of northern China. Patients will
      simultaneously undergo CTCs tests and FNAB. And following treatments will be performed
      according to the previous standard. Allowed by the patients, the investigators will obtain
      10ml peripheral blood samples from the participants to make a CTCs test before any FNAB. The
      primary end point is the pathologically confirmed benign versus malignant thyroid disease,
      which including surgical pathology and diagnostic results of FNAB.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: post-operative pathology
time frame: 10 days after surgery
description: Patients with malignant results of FNAB (Bethesda V and VI)non-diagnostic results of FNAB (Bethesda class I , III, IV)will be suggested to undergo surgery. Those patients who underwent surgery are enrolled in our study and are performed a post-operative pathology, which have a higher evidence rank than FNAB. According to post-operative pathology, any type of thyroid carcinoma is defined as malignant, and patients who have not been strong enough to be diagnosed with carcinoma is defined as benign disease.
measure: diagnostic results of FNAB
time frame: 10 days after FNAB
description: The result of FNAB are classified by Bethesda rating system. Bethesda class I is considered the sample is not qualified, Bethesda class II is defined as benign, Bethesda class III and IV are defined as non-diagnostic result, which need further verified by surgery.Bethesda class V and VI are defined as malignant.
arm group label: circulating tumor cells
arm group type: Experimental
description: circulating tumor cells test and FNAB will be performed at the same time
intervention type: Diagnostic Test
intervention name: circulating tumor cells test
description: 10 ml Peripheral blood are drawn from patients enrolled before surgery/FNAB and centrifuged to collect the peripheral blood mononuclear cells. Then, negative and positive immunomagnetic selections are used to exclude white blood cells and enrich tumor cells. After isolating mRNA, RT-PCR array is used to measure expression of target genes.
arm group label: circulating tumor cells
intervention type: Diagnostic Test
intervention name: Fine needle aspiration biopsy
description: patients with potential malignant thyroid nodules are performed fine needle aspiration biopsy with the aid of ultrasound. The result of FNAB were classified by Bethesda rating system.
arm group label: circulating tumor cells
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: jie liu, MD
role: Principal Investigator
affiliation: Cancer Hospital, Chinese Academy of Medical Science
last name: jie liu, MD
phone: 8610-87787180
email: liujie10-11@vip.163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: liu jie
investigator title: Clinical Professor
mesh term: Neoplastic Cells, Circulating
mesh term: Thyroid Nodule
mesh term: Thyroid Diseases
sharing ipd: No