<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/NCT04497714</url>
  </required_header>
  <id_info>
    <org_study_id>研2020-539</org_study_id>
    <nct_id>NCT04497714</nct_id>
  </id_info>
  <brief_title>Identifying Ultrasonic Diagnostic Characteristics of Cervical Lymphadenopathy: A Retrospective, Multicenter Study</brief_title>
  <official_title>Identifying Ultrasonic Diagnostic Characteristics of Cervical Lymphadenopathy: A Retrospective, Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</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>
      The observed indexes of the four cervical lymph node diseases were identified by informatics&#xD;
      methods, and the differences in the diagnosis of the four diseases were evaluated, so as to&#xD;
      improve the clinical diagnosis rate and provide a research basis for the ultrasonic&#xD;
      evaluation of the surgical indications of cervical lymph node diseases in the future.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">January 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cervical lymph nodes tuberculosis</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>It was identified as cervical lymph node tuberculosis by imaging observation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cervical lymphoma</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>It was identified as cervical lymphoma by imaging observation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cervical lymph node metastasis</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>It was identified as Cervical lymph node metastasis by imaging observation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cervical Reactive hyperplasia</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>It was identified as Cervical Reactive hyperplasia by imaging observation</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">500</enrollment>
  <condition>Lymph Node Disease</condition>
  <condition>Ultrasound Therapy; Complications</condition>
  <arm_group>
    <arm_group_label>Cervical lymph nodes tuberculosis</arm_group_label>
    <description>The patients with Cervical lymph nodes tuberculosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cervical lymphoma</arm_group_label>
    <description>The patients with</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cervical lymph node metastasis</arm_group_label>
    <description>The patients with</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cervical Reactive hyperplasia</arm_group_label>
    <description>The patients with</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ultrasonic image collection</intervention_name>
    <description>Ultrasonic image collection,consist of three static images and one dynamic image</description>
    <arm_group_label>Cervical Reactive hyperplasia</arm_group_label>
    <arm_group_label>Cervical lymph node metastasis</arm_group_label>
    <arm_group_label>Cervical lymph nodes tuberculosis</arm_group_label>
    <arm_group_label>Cervical lymphoma</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with one of these four diseases&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with one of these four diseases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Patients with severe heart and brain diseases and poor coagulation function. 2.&#xD;
             Undiagnosed patients are not included in the statistical analysis. 3. Image distortion&#xD;
             of CEUS acquisition cannot be analyzed.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>0571</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>August 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>August 2, 2020</last_update_submitted>
  <last_update_submitted_qc>August 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</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>Lymphadenopathy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>individual participant data(IPD) can be shared after the main unit publish articles</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>by request</ipd_time_frame>
    <ipd_access_criteria>by request</ipd_access_criteria>
  </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/NCT04497714
org study id: 研2020-539
nct id: NCT04497714
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The observed indexes of the four cervical lymph node diseases were identified by informatics
      methods, and the differences in the diagnosis of the four diseases were evaluated, so as to
      improve the clinical diagnosis rate and provide a research basis for the ultrasonic
      evaluation of the surgical indications of cervical lymph node diseases in the future.
observational model: Cohort
time perspective: Retrospective
measure: Cervical lymph nodes tuberculosis
time frame: through study completion, an average of 1 year
description: It was identified as cervical lymph node tuberculosis by imaging observation
measure: Cervical lymphoma
time frame: through study completion, an average of 1 year
description: It was identified as cervical lymphoma by imaging observation
measure: Cervical lymph node metastasis
time frame: through study completion, an average of 1 year
description: It was identified as Cervical lymph node metastasis by imaging observation
measure: Cervical Reactive hyperplasia
time frame: through study completion, an average of 1 year
description: It was identified as Cervical Reactive hyperplasia by imaging observation
arm group label: Cervical lymph nodes tuberculosis
description: The patients with Cervical lymph nodes tuberculosis
arm group label: Cervical lymphoma
description: The patients with
arm group label: Cervical lymph node metastasis
description: The patients with
arm group label: Cervical Reactive hyperplasia
description: The patients with
intervention type: Diagnostic Test
intervention name: Ultrasonic image collection
description: Ultrasonic image collection,consist of three static images and one dynamic image
arm group label: Cervical Reactive hyperplasia
arm group label: Cervical lymph node metastasis
arm group label: Cervical lymph nodes tuberculosis
arm group label: Cervical lymphoma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Lymphadenopathy
sharing ipd: Yes
ipd description: individual participant data(IPD) can be shared after the main unit publish articles
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: by request
ipd access criteria: by request