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/NCT06032481</url>
    </required_header>
    <id_info>
      <org_study_id>FujianMCHH-Xu01</org_study_id>
      <nct_id>NCT06032481</nct_id>
    </id_info>
    <brief_title>System to Evaluate the Risk of Lymph Node Metastasis Preoperatively in Cervical Cancer</brief_title>
    <official_title>Preoperative Scoring System to Predict the Risk of Lymph Node Metastasis in Cervical Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fujian Maternity and Child Health Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fujian Maternity and Child Health Hospital</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 lymph node status is difficult to be assessed preoperatively, this study aimed to develop&#xD;
        a scoring system for predicting the risk of LNM in cervical cancer patients before operation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Lymph nodes metastasis (LNM) was proved to be a critical risk factor related to the survival&#xD;
        to cervical cancer survival. However, preoperative pelvic magnetic resonance imaging (MR) or&#xD;
        computed tomography (CT) tests are less sensitive to assess the risk of lymph node&#xD;
        metastasis. PET-CT is too expensive and radiative to be widely used in clinical practice. A&#xD;
        model was constructed based on clinical indicators to predict lymph node metastasis&#xD;
        preoperatively, providing a reference for clinical treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2012</start_date>
    <completion_date type="Actual">March 15, 2023</completion_date>
    <primary_completion_date type="Actual">December 1, 2019</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>Overall survival</measure>
      <time_frame>60 months</time_frame>
      <description>death or loss of follow-up</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Risk factors influenced LNM</measure>
      <time_frame>60 months</time_frame>
      <description>A multivariable logistic regression analysis was used to analysis the independent factors that contribute to LNM.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The accuracy of the model</measure>
      <time_frame>60 months</time_frame>
      <description>The AUC curve was used to assess the discrimination of the scoring system. The comparison between predicted (mean ± SD) and observed rates of LNM was used to test the calibration. The Hosmer-Lemeshow test evaluated the model fit.</description>
    </secondary_outcome>
    <enrollment type="Actual">426</enrollment>
    <condition>Cervical Cancer</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>surgery</intervention_name>
      <description>Patients confirmed cervical cancer were undergone radical hysterectomy with pelvic lymphadenectomy</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          A total of 426 patients with cervical cancer who underwent radical resection in China were&#xD;
          recruited&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Clinical diagnosis of cervical cancer&#xD;
  &#xD;
            -  FIGO stage IB1-IIA1&#xD;
  &#xD;
            -  Undergone radical hysterectomy with pelvic lymphadenectomy&#xD;
  &#xD;
            -  Peformed pelvic MRI examination preoperatively&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Had distant metastases diagnosed before or during the surgery&#xD;
  &#xD;
            -  Underwent neoadjuvant radiotherapy preoperatively&#xD;
  &#xD;
            -  Underwent neoadjuvant chemotherapy preoperatively&#xD;
  &#xD;
            -  Incomplete or inaccuratemedical records&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Pengming Sun, Ph.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fujian Maternity and Child Health Hospital</affiliation>
    </overall_official>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fujian Maternity and Child Health Hospital</investigator_affiliation>
      <investigator_full_name>Yebin Feng</investigator_full_name>
      <investigator_title>Director</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Uterine Cervical Neoplasms</mesh_term>
      <mesh_term>Lymphatic Metastasis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06032481
  org study id: FujianMCHH-Xu01
  nct id: NCT06032481
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The lymph node status is difficult to be assessed preoperatively, this study aimed to develop
        a scoring system for predicting the risk of LNM in cervical cancer patients before operation.
  Lymph nodes metastasis (LNM) was proved to be a critical risk factor related to the survival
        to cervical cancer survival. However, preoperative pelvic magnetic resonance imaging (MR) or
        computed tomography (CT) tests are less sensitive to assess the risk of lymph node
        metastasis. PET-CT is too expensive and radiative to be widely used in clinical practice. A
        model was constructed based on clinical indicators to predict lymph node metastasis
        preoperatively, providing a reference for clinical treatment.
  observational model: Cohort
  time perspective: Retrospective
  measure: Overall survival
  time frame: 60 months
  description: death or loss of follow-up
  measure: Risk factors influenced LNM
  time frame: 60 months
  description: A multivariable logistic regression analysis was used to analysis the independent factors that contribute to LNM.
  measure: The accuracy of the model
  time frame: 60 months
  description: The AUC curve was used to assess the discrimination of the scoring system. The comparison between predicted (mean ± SD) and observed rates of LNM was used to test the calibration. The Hosmer-Lemeshow test evaluated the model fit.
  intervention type: Procedure
  intervention name: surgery
  description: Patients confirmed cervical cancer were undergone radical hysterectomy with pelvic lymphadenectomy
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 25 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Pengming Sun, Ph.D
  role: Principal Investigator
  affiliation: Fujian Maternity and Child Health Hospital
  responsible party type: Principal Investigator
  investigator affiliation: Fujian Maternity and Child Health Hospital
  investigator full name: Yebin Feng
  investigator title: Director
  mesh term: Uterine Cervical Neoplasms
  mesh term: Lymphatic Metastasis
  sharing ipd: Undecided