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/NCT05997147</url>
    </required_header>
    <id_info>
      <org_study_id>Panc-LVI-2023810</org_study_id>
      <nct_id>NCT05997147</nct_id>
    </id_info>
    <brief_title>A Preoperative Model to Predict the Lymphovascular Invasion in Pancreatic Ductal Adenocarcinoma</brief_title>
    <official_title>Development and Validation of a Preoperative Model to Predict the Lymphovascular Invasion of Pancreatic Ductal Adenocarcinoma: a Multicenter Retrospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tianjin Medical University Cancer Institute and Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tianjin Medical University Cancer Institute and 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>
        Importance: Lymphovascular invasion (LVI) is a poor prognosis pathologic feature in&#xD;
        pancreatic ductal adenocarcinoma (PDAC) patients. Neoadjuvant therapy may bring survival&#xD;
        benefits to these patients.&#xD;
  &#xD;
        Objective: To construct a preoperative model which could predict LVI in PDAC patients and&#xD;
        further validate it in other cohorts.&#xD;
  &#xD;
        Design, Setting, and Participants: Patients from 3 three tertiary hospitals were included in&#xD;
        this study. Univariate and multivariate Logistic regression analyses were conducted to define&#xD;
        independent prediction factors of LVI. A nomogram was constructed based on the result of&#xD;
        multivariate analysis.The predictive value of the model was assessed using receiver operating&#xD;
        characteristic (ROC) curves and the maximum Youden index of the ROC curve was defined as the&#xD;
        cut-off point. The calibration plot was utilized to assess the concordance of the model. The&#xD;
        decision curve analyses (DCA) were applied to estimate the clinical benefit of using this&#xD;
        model to predict LVI.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2023</completion_date>
    <primary_completion_date type="Actual">August 5, 2023</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>Recurrence-free survival</measure>
      <time_frame>10 years</time_frame>
      <description>Time from operation to the detection of recurrence or last follow-up</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>10 years</time_frame>
      <description>Time between surgical resection to death or the last follow-up.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">1009</enrollment>
    <condition>Predictive Cancer Model</condition>
    <condition>Pancreas Cancer</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who were pathologically diagnosed as PDAC and received curative surgery.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who were pathologically diagnosed as PDAC and received curative surgery.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with distant metastasis; Patients who received neoadjuvant therapy; Patients&#xD;
               with a survival time of less than 1 month.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jihui Hao, Dr</last_name>
      <role>Study Chair</role>
      <affiliation>Tianjin Medical University Cancer Institute and Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jihui Hao, Dr</last_name>
      <phone>+8618622221120</phone>
      <email>haojihui@tjmuch.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yiping Zou, Dr</last_name>
      <phone>+8615875353255</phone>
      <email>yiping-zou@foxmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Tianjin Medical University Cancer Institute and Hospital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <zip>300060</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jihui Hao, Dr</last_name>
        <phone>+8618622221120</phone>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</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>Adenocarcinoma</mesh_term>
      <mesh_term>Pancreatic Neoplasms</mesh_term>
    </condition_browse>
    <!-- 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/NCT05997147
  org study id: Panc-LVI-2023810
  nct id: NCT05997147
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Importance: Lymphovascular invasion (LVI) is a poor prognosis pathologic feature in
        pancreatic ductal adenocarcinoma (PDAC) patients. Neoadjuvant therapy may bring survival
        benefits to these patients.
  
        Objective: To construct a preoperative model which could predict LVI in PDAC patients and
        further validate it in other cohorts.
  
        Design, Setting, and Participants: Patients from 3 three tertiary hospitals were included in
        this study. Univariate and multivariate Logistic regression analyses were conducted to define
        independent prediction factors of LVI. A nomogram was constructed based on the result of
        multivariate analysis.The predictive value of the model was assessed using receiver operating
        characteristic (ROC) curves and the maximum Youden index of the ROC curve was defined as the
        cut-off point. The calibration plot was utilized to assess the concordance of the model. The
        decision curve analyses (DCA) were applied to estimate the clinical benefit of using this
        model to predict LVI.
  observational model: Cohort
  time perspective: Retrospective
  measure: Recurrence-free survival
  time frame: 10 years
  description: Time from operation to the detection of recurrence or last follow-up
  measure: Overall survival
  time frame: 10 years
  description: Time between surgical resection to death or the last follow-up.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Jihui Hao, Dr
  role: Study Chair
  affiliation: Tianjin Medical University Cancer Institute and Hospital
  last name: Jihui Hao, Dr
  phone: +8618622221120
  email: haojihui@tjmuch.com
  last name: Yiping Zou, Dr
  phone: +8615875353255
  email: yiping-zou@foxmail.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Adenocarcinoma
  mesh term: Pancreatic Neoplasms