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/NCT06037174</url>
    </required_header>
    <id_info>
      <org_study_id>SYSKY-2023-472-01</org_study_id>
      <nct_id>NCT06037174</nct_id>
    </id_info>
    <brief_title>Comparison of Quality of Life in Patients With Differentiated Thyroid Carcinoma Undergoing Different Surgery</brief_title>
    <official_title>Comparison of Quality of Life Between Patients With Early Differentiated Thyroid Cancer Undergoing Minimally Invasive and Open Surgery: A Prospective Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 incidence of thyroid cancer has increased rapidly in recent years, especially in women.&#xD;
        Early differentiated thyroid cancer has a good prognosis, and surgery is the main treatment.&#xD;
        Traditional open surgery would leave a scar on the neck. However, emerging minimally invasive&#xD;
        procedures can avoid the scar on the neck, resulting in better aesthetic effect, which would&#xD;
        have an impact on the quality of life of patients to a certain degree.&#xD;
  &#xD;
        This study intend to follow up patients regularly with early differentiated thyroid cancer&#xD;
        undergoing different surgery. The quality of life, voice, scar would be assessed by&#xD;
        authoritative questionaires or scales. We hope to demonstrate that minimally invasive surgery&#xD;
        is better than traditional open surgery in order to provide reliable evidence for clinical&#xD;
        practice.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The incidence of thyroid cancer has increased rapidly in recent years, especially in women.&#xD;
        Differentiated thyroid cancer takes the largest proportion in thyroid cancer, but it has a&#xD;
        good prognosis. For early differentiated thyroid cancer, surgery is the main treatment.&#xD;
        Traditional open surgery would leave a scar on the neck, which is especially troublesome for&#xD;
        female patients. However, emerging minimally invasive procedures, such as endoscopy-assisted&#xD;
        subclavian approach, robot-assisted transaxillary or transoral approach, etc., can avoid the&#xD;
        scar on the neck, resulting in better aesthetic effect, which would have an impact on the&#xD;
        quality of life of patients to a certain degree.&#xD;
  &#xD;
        This study intend to follow up patients regularly with early differentiated thyroid cancer&#xD;
        undergoing surgery according to a prospective cohort design. The evaluation questionnaires&#xD;
        including quality of life, voice and scar would be completed to demonstrate that minimally&#xD;
        invasive surgery is better than traditional open surgery not only in the way of&#xD;
        effectiveness, but also in the quality of life. We hope to provide reliable evidence for&#xD;
        clinical practice by this study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">September 10, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 10, 2024</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>change of quality of life (SF-36)</measure>
      <time_frame>baseline, 1month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery</time_frame>
      <description>change of the scores of the SF-36（36-item Short-Form）questionaire</description>
    </primary_outcome>
    <primary_outcome>
      <measure>change of quality of life (Thyca-Qol)</measure>
      <time_frame>baseline, 1month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery</time_frame>
      <description>change of the scores of the Thyca-Qol（Thyroid Cancer-specific Quality of Life） questionaire</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>voice handicap index</measure>
      <time_frame>baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery</time_frame>
      <description>assessment of quality of voice</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>scores of the surgical scar</measure>
      <time_frame>1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery</time_frame>
      <description>scores of the questionaires (POSAS) about scar</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>level of thyroglobulin</measure>
      <time_frame>baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery</time_frame>
      <description>an indicator to monitor tumor residual or recurrence</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>level of calcium</measure>
      <time_frame>baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery</time_frame>
      <description>to indicate whether the patient have hypocalcemia</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>operation duration</measure>
      <time_frame>Intraoperative</time_frame>
      <description>time for operation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>blood loss</measure>
      <time_frame>up to 1 week after surgery</time_frame>
      <description>blood loss during operation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>postoperative drainage</measure>
      <time_frame>up to 1 week after surgery</time_frame>
      <description>drainage volume after surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>complications</measure>
      <time_frame>baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery</time_frame>
      <description>complication events after surgery, e.g. hoarseness, hypocalcemia, hemorrhage, seroma</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>satisfaction of the surgery</measure>
      <time_frame>1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery</time_frame>
      <description>Visual Analog Score for satisfaction</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">230</enrollment>
    <condition>Thyroid Cancer</condition>
    <arm_group>
      <arm_group_label>minimally invasive surgery</arm_group_label>
      <description>undergoing thyroidectomy with endoscopy-assisted subclavian approach, robot-assisted transaxillary approach, robot-assisted transoral approach, robot-assisted retroauricular approach, etc.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>traditional open surgery</arm_group_label>
      <description>undergoing thyroidectomy with tradition open surgery</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>minimally invasive procedure</intervention_name>
      <description>different minimally invasive approach to complete thyroidectomy, including endoscopy-assisted subclavian approach, robot-assisted transaxillary or transoral approach (not leaving scar on the neck)</description>
      <arm_group_label>minimally invasive surgery</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        thyroid function test, thyroglobin, etc.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          primary care clinic&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥18 years and &lt; 70 years;&#xD;
  &#xD;
            -  Biopsy or surgical pathology indicated differentiated thyroid carcinoma (papillary&#xD;
               thyroid carcinoma, follicular carcinoma);&#xD;
  &#xD;
            -  stage T1~T3a, N0~N1a, M0;&#xD;
  &#xD;
            -  Ability to read and write Chinese;&#xD;
  &#xD;
            -  Willingness to follow up.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt; 18 years old or ≥70 years old;&#xD;
  &#xD;
            -  Biopsy or surgical pathology indicated medullary carcinoma or anaplastic thyroid&#xD;
               carcinoma;&#xD;
  &#xD;
            -  Aggressive histology: tall cell, columnar cell, hobnail variant, etc.&#xD;
  &#xD;
            -  Mixed with medullary carcinoma or anaplastic thyroid carcinoma;&#xD;
  &#xD;
            -  High risk of recurrence (according to ATA guideline);&#xD;
  &#xD;
            -  Lateral cervical lymph node metastasis or distant metastasis;&#xD;
  &#xD;
            -  Suffer from other malignant tumors;&#xD;
  &#xD;
            -  History of thyroid surgery or cervical lymph node dissection;&#xD;
  &#xD;
            -  Cognition or behavior impairment.&#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>Xiaoming Huang</last_name>
      <role>Study Director</role>
      <affiliation>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xiaoming Huang, Professor</last_name>
      <phone>13602808820</phone>
      <email>hxming@mail.sysu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Peiliang Lin, Doctor</last_name>
      <phone>18520393810</phone>
      <email>linpliang3@mail.sysu.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sun Yat-sen Memorial Hopsital</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510289</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xiaoming Huang, Professor</last_name>
        <phone>13602808820</phone>
        <email>hxming@mail.sysu.edu.cn</email>
      </contact>
      <contact_backup>
        <last_name>Peiliang Lin, Doctor</last_name>
        <phone>18520393810</phone>
        <email>linpliang3@mail.sysu.edu.cn</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 16, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</investigator_affiliation>
      <investigator_full_name>Xiaoming Huang</investigator_full_name>
      <investigator_title>Professor; Director</investigator_title>
    </responsible_party>
    <keyword>thyroid cancer</keyword>
    <keyword>quality of life</keyword>
    <keyword>minimally invasive</keyword>
    <keyword>surgery</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Thyroid Neoplasms</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>
  
  
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/NCT06037174
  org study id: SYSKY-2023-472-01
  nct id: NCT06037174
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The incidence of thyroid cancer has increased rapidly in recent years, especially in women.
        Early differentiated thyroid cancer has a good prognosis, and surgery is the main treatment.
        Traditional open surgery would leave a scar on the neck. However, emerging minimally invasive
        procedures can avoid the scar on the neck, resulting in better aesthetic effect, which would
        have an impact on the quality of life of patients to a certain degree.
  
        This study intend to follow up patients regularly with early differentiated thyroid cancer
        undergoing different surgery. The quality of life, voice, scar would be assessed by
        authoritative questionaires or scales. We hope to demonstrate that minimally invasive surgery
        is better than traditional open surgery in order to provide reliable evidence for clinical
        practice.
  The incidence of thyroid cancer has increased rapidly in recent years, especially in women.
        Differentiated thyroid cancer takes the largest proportion in thyroid cancer, but it has a
        good prognosis. For early differentiated thyroid cancer, surgery is the main treatment.
        Traditional open surgery would leave a scar on the neck, which is especially troublesome for
        female patients. However, emerging minimally invasive procedures, such as endoscopy-assisted
        subclavian approach, robot-assisted transaxillary or transoral approach, etc., can avoid the
        scar on the neck, resulting in better aesthetic effect, which would have an impact on the
        quality of life of patients to a certain degree.
  
        This study intend to follow up patients regularly with early differentiated thyroid cancer
        undergoing surgery according to a prospective cohort design. The evaluation questionnaires
        including quality of life, voice and scar would be completed to demonstrate that minimally
        invasive surgery is better than traditional open surgery not only in the way of
        effectiveness, but also in the quality of life. We hope to provide reliable evidence for
        clinical practice by this study.
  observational model: Cohort
  time perspective: Prospective
  measure: change of quality of life (SF-36)
  time frame: baseline, 1month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
  description: change of the scores of the SF-36（36-item Short-Form）questionaire
  measure: change of quality of life (Thyca-Qol)
  time frame: baseline, 1month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
  description: change of the scores of the Thyca-Qol（Thyroid Cancer-specific Quality of Life） questionaire
  measure: voice handicap index
  time frame: baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
  description: assessment of quality of voice
  measure: scores of the surgical scar
  time frame: 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
  description: scores of the questionaires (POSAS) about scar
  measure: level of thyroglobulin
  time frame: baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
  description: an indicator to monitor tumor residual or recurrence
  measure: level of calcium
  time frame: baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
  description: to indicate whether the patient have hypocalcemia
  measure: operation duration
  time frame: Intraoperative
  description: time for operation
  measure: blood loss
  time frame: up to 1 week after surgery
  description: blood loss during operation
  measure: postoperative drainage
  time frame: up to 1 week after surgery
  description: drainage volume after surgery
  measure: complications
  time frame: baseline, 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
  description: complication events after surgery, e.g. hoarseness, hypocalcemia, hemorrhage, seroma
  measure: satisfaction of the surgery
  time frame: 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery
  description: Visual Analog Score for satisfaction
  arm group label: minimally invasive surgery
  description: undergoing thyroidectomy with endoscopy-assisted subclavian approach, robot-assisted transaxillary approach, robot-assisted transoral approach, robot-assisted retroauricular approach, etc.
  arm group label: traditional open surgery
  description: undergoing thyroidectomy with tradition open surgery
  intervention type: Procedure
  intervention name: minimally invasive procedure
  description: different minimally invasive approach to complete thyroidectomy, including endoscopy-assisted subclavian approach, robot-assisted transaxillary or transoral approach (not leaving scar on the neck)
  arm group label: minimally invasive surgery
  thyroid function test, thyroglobin, etc.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Xiaoming Huang
  role: Study Director
  affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  last name: Xiaoming Huang, Professor
  phone: 13602808820
  email: hxming@mail.sysu.edu.cn
  last name: Peiliang Lin, Doctor
  phone: 18520393810
  email: linpliang3@mail.sysu.edu.cn
  facility: 
  contact: 
  contact backup: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  investigator full name: Xiaoming Huang
  investigator title: Professor; Director
  mesh term: Thyroid Neoplasms
  mesh term: Thyroid Diseases
  sharing ipd: No