xml: <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/NCT05962892</url>
    </required_header>
    <id_info>
      <org_study_id>MR-11-23-009728</org_study_id>
      <nct_id>NCT05962892</nct_id>
    </id_info>
    <brief_title>A Study of Factors Influencing Recurrence After Thermal Ablation of Papillary Thyroid Carcinoma</brief_title>
    <official_title>A Study of Factors Influencing Recurrence After Thermal Ablation of Papillary Thyroid Carcinoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beijing Friendship Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beijing Friendship Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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>
        A prospective cohort of papillary thyroid carcinoma(PTC), patients who received thermal&#xD;
        ablation in our hospital since February 2023 was established as the study object.&#xD;
        Preoperative and postoperative demographic data, ultrasonography, other relevant laboratory&#xD;
        tests, and thyroid disease-related scales such as fatigue, depression, and stress were&#xD;
        collected. The influencing factors of PTC recurrence were analyzed.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">February 28, 2028</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2028</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <target_duration>5 Years</target_duration>
    <primary_outcome>
      <measure>the recurrence of PTC</measure>
      <time_frame>1 to 5 years</time_frame>
      <description>the recurrence of PTC during follow-up</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">600</enrollment>
    <condition>Papillary Thyroid Carcinoma</condition>
    <condition>Thermal Ablation</condition>
    <arm_group>
      <arm_group_label>No Intervention</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No Intervention</intervention_name>
      <description>No Intervention</description>
      <arm_group_label>No Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with pathologically proven PTC underwent ultrasound-guided percutaneous thermal&#xD;
          ablation.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          ①≥18 years old; ② Obtain informed consent; ③ Ultrasonography showed that malignant nodules&#xD;
          were single, the maximum diameter of nodules was ≤1cm and the distance from the capsule was&#xD;
          ≥2mm. ④ no lymph node metastasis or other extra-glandular metastasis in the neck; ⑤ PTC was&#xD;
          confirmed by fine needle puncture pathology; ⑥ Patients who do not meet Article 3, who&#xD;
          still strongly request thermal ablation while fully informing the patient of the risk of&#xD;
          recurrence, and who have been clinically assessed to be technically capable of thermal&#xD;
          ablation Exclusion Criteria:① Pregnant or lactating patients; ② Patients with other&#xD;
          malignant tumors and not suitable for ablation by clinical evaluation; ③ Patients who&#xD;
          cannot tolerate surgery; ④ Patients with cognitive impairment and other conditions who&#xD;
          cannot accurately fill in thyroid-related questionnaires.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Xianquan Shi, PhD</last_name>
      <phone>18510085125</phone>
      <email>sonoshixq@ccmu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Beijing Friendship Hospital</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xianquan Shi</last_name>
        <phone>18510085125</phone>
        <email>sonoshixq@ccmu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>February 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Papillary Thyroid Carcinoma</keyword>
    <keyword>cohort</keyword>
    <keyword>Thermal Ablation</keyword>
    <keyword>Recurrence</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Thyroid Neoplasms</mesh_term>
      <mesh_term>Thyroid Cancer, Papillary</mesh_term>
      <mesh_term>Thyroid Diseases</mesh_term>
      <mesh_term>Recurrence</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05962892
  org study id: MR-11-23-009728
  nct id: NCT05962892
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  A prospective cohort of papillary thyroid carcinoma(PTC), patients who received thermal
        ablation in our hospital since February 2023 was established as the study object.
        Preoperative and postoperative demographic data, ultrasonography, other relevant laboratory
        tests, and thyroid disease-related scales such as fatigue, depression, and stress were
        collected. The influencing factors of PTC recurrence were analyzed.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: the recurrence of PTC
  time frame: 1 to 5 years
  description: the recurrence of PTC during follow-up
  arm group label: No Intervention
  intervention type: Other
  intervention name: No Intervention
  description: No Intervention
  arm group label: No Intervention
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Xianquan Shi, PhD
  phone: 18510085125
  email: sonoshixq@ccmu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Thyroid Neoplasms
  mesh term: Thyroid Cancer, Papillary
  mesh term: Thyroid Diseases
  mesh term: Recurrence
  sharing ipd: No