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/NCT06008548</url>
    </required_header>
    <id_info>
      <org_study_id>liulei</org_study_id>
      <nct_id>NCT06008548</nct_id>
    </id_info>
    <brief_title>A New Conception About Individualized Treatment Allocation for HCC</brief_title>
    <acronym>PTA4HCC</acronym>
    <official_title>A New Conception About Individualized Treatment Allocation for HCC-Using Machine Learning</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tang-Du Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Air Force Military Medical University, China</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Army Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The First Affiliated Hospital of Shanxi Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Sun Yat-sen University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shaanxi Provincial People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Xijing Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Health Science Center of Xi'an Jiaotong University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Tang-Du 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>
        The current guidelines on hepatocellular carcinoma (HCC) aimed to build effective prognostic&#xD;
        stratification strategies to guide therapeutic allocation; however, the current guidelines&#xD;
        did not consider the simultaneous comparison of distinct therapies in similar populations.&#xD;
        Here, the investigators aimed to develop and validate a new, integrated prognostic scheme for&#xD;
        HCC patients using artificial intelligence (AI) to simulate the survival outcomes of patients&#xD;
        allocated to different treatments.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Given that liver resection (LR) and transarterial chemoembolization (TACE) are the mainstay&#xD;
        curative and palliative therapies for HCC, respectively, patients who underwent LR or TACE&#xD;
        were included in the study. Various prognostic AI algorithms were modeled using data from a&#xD;
        large multi-institutional cohort, where LR and TACE were considered independent factors. The&#xD;
        C-index, Brier score (BS), and area under the receiver operating characteristic curve (auROC)&#xD;
        were calculated to estimate the AI models.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2010</start_date>
    <completion_date type="Actual">October 1, 2021</completion_date>
    <primary_completion_date type="Actual">January 30, 2021</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>overall survival</measure>
      <time_frame>5 years</time_frame>
      <description>Overall survival (OS) was defined as the time interval between initial TACE or LR and all-cause death. Patients who survived up to the last follow-up date</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">4991</enrollment>
    <condition>HCC</condition>
    <condition>Transarterial Chemoembolization</condition>
    <condition>Resection</condition>
    <arm_group>
      <arm_group_label>TACE group</arm_group_label>
      <description>Incorporated HCC patients underwent TACE therapy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Liver resection group</arm_group_label>
      <description>Incorporated HCC patients underwent liver resection therapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>TACE</intervention_name>
      <arm_group_label>TACE group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Between January 2010 and October 2021, a total of 4991 consecutive HCC patients receiving&#xD;
          LR or TACE from 15 Chinese tertiary hospitals were retrospectively screened. HCC was&#xD;
          diagnosed based on either imaging or pathological results as previously described&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria&#xD;
  &#xD;
            -  Diagnosed with HCC&#xD;
  &#xD;
            -  Receiving LR or TACE therapy&#xD;
  &#xD;
            -  Complete clinical information&#xD;
  &#xD;
            -  Preserved liver function (Child-Pugh Score [CPS] ≤ 7)&#xD;
  &#xD;
            -  PS 0-1&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
            -  Vascular invasion or extrahepatic spread;&#xD;
  &#xD;
            -  Ecompensated liver cirrhosis ;&#xD;
  &#xD;
            -  Younger than 18 years;&#xD;
  &#xD;
            -  Duration of follow-up of fewer than 30 days.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lei Liu, doctor</last_name>
      <role>Study Director</role>
      <affiliation>Tangdu hospital, Air Force medical university</affiliation>
    </overall_official>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>August 20, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT06008548/Prot_SAP_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>August 20, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT06008548/ICF_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06008548
  org study id: liulei
  nct id: NCT06008548
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The current guidelines on hepatocellular carcinoma (HCC) aimed to build effective prognostic
        stratification strategies to guide therapeutic allocation; however, the current guidelines
        did not consider the simultaneous comparison of distinct therapies in similar populations.
        Here, the investigators aimed to develop and validate a new, integrated prognostic scheme for
        HCC patients using artificial intelligence (AI) to simulate the survival outcomes of patients
        allocated to different treatments.
  Given that liver resection (LR) and transarterial chemoembolization (TACE) are the mainstay
        curative and palliative therapies for HCC, respectively, patients who underwent LR or TACE
        were included in the study. Various prognostic AI algorithms were modeled using data from a
        large multi-institutional cohort, where LR and TACE were considered independent factors. The
        C-index, Brier score (BS), and area under the receiver operating characteristic curve (auROC)
        were calculated to estimate the AI models.
  observational model: Other
  time perspective: Retrospective
  measure: overall survival
  time frame: 5 years
  description: Overall survival (OS) was defined as the time interval between initial TACE or LR and all-cause death. Patients who survived up to the last follow-up date
  arm group label: TACE group
  description: Incorporated HCC patients underwent TACE therapy.
  arm group label: Liver resection group
  description: Incorporated HCC patients underwent liver resection therapy.
  intervention type: Procedure
  intervention name: TACE
  arm group label: TACE group
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Lei Liu, doctor
  role: Study Director
  affiliation: Tangdu hospital, Air Force medical university
  responsible party type: Sponsor
  sharing ipd: No
  provided document: 
  provided document: 