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/NCT06041009</url>
    </required_header>
    <id_info>
      <org_study_id>2023SDU-QILU-4</org_study_id>
      <nct_id>NCT06041009</nct_id>
    </id_info>
    <brief_title>Pancreatic Cancer Screening Through the Detection of Elastase-1 Combined With Other Examinations</brief_title>
    <official_title>Pancreatic Cancer Screening Through the Detection of Elastase-1 Combined With Other Examinations: A Multicenter, Prospective, Diagnostic Clinical Cohort Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Qilu Hospital of Shandong University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>First Affiliated Hospital of Guangxi Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Wuhan Union Hospital, China</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>LanZhou University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Qilu Hospital of Shandong 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>
        This is a prospective cohort study. The investigators enroll subjects with pancreatic ductal&#xD;
        adenocarcinoma (PDAC), individuals at high risk for PDAC, patients with other pancreatic&#xD;
        diseases, patients with CA19-9 elevation and controls without pancreatic disease. This study&#xD;
        aims to establish a diagnostic prediction model by using elastase 1, common clinical&#xD;
        serological examinations, and imaging examinations including endoscopic ultrasonography&#xD;
        (EUS), and to explore the diagnostic ability of the model in the high-risk population of&#xD;
        PDAC. Besides, the investigators search for new biomarkers by multi-omics studies of serum&#xD;
        and pancreatic tissues to further improve the diagnostic performance of this model. In&#xD;
        conclusion, this study seeks a robust diagnostic prediction model to diagnose PDAC,&#xD;
        especially early resectable PDAC.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 20, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)</measure>
      <time_frame>2 years</time_frame>
      <description>The diagnostic value of diagnostic model in diagnosing PDAC, especially early resectable PDAC.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)</measure>
      <time_frame>2 years</time_frame>
      <description>The diagnostic value of diagnostic model versus EUS or other imaging examinations combined with diagnostic model in diagnosing PDAC.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The content of elastase 1</measure>
      <time_frame>2 years</time_frame>
      <description>The content of elastase-1 in cystic fluid and serum are measured (units: ng/dl)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)</measure>
      <time_frame>2 years</time_frame>
      <description>The ability of diagnostic models, multi-omics novel tumor markers, and common tumor markers to distinguish PDAC, benign pancreatic disease, borderline malignant disease, patients with abnormally elevated CA199, and controls without pancreatic disease.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)</measure>
      <time_frame>2 years</time_frame>
      <description>The diagnostic value of the diagnostic model, new tumor markers of multi-omics, and the common tumor markers to distinguish pancreatic tumors of different sites and sizes.</description>
    </secondary_outcome>
    <number_of_groups>6</number_of_groups>
    <enrollment type="Anticipated">2100</enrollment>
    <condition>Pancreatic Ductal Adenocarcinoma</condition>
    <condition>Pancreatic Diseases</condition>
    <condition>Pancreatic Elastase 1</condition>
    <condition>Pancreatic Neuroendocrine Tumor</condition>
    <condition>Pancreatitis</condition>
    <condition>Pancreatic Neoplasms</condition>
    <arm_group>
      <arm_group_label>Patients with PDAC</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Individuals at high risk for PDAC</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Group of neuroendocrine neoplasm of pancreas</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Group of solid pseudopapillary tumor of pancreas</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Group of abnormally elevated CA19-9</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Controls without pancreatic disease or elevated CA19-9</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Pancreatic elastase-1 in blood serum</intervention_name>
      <description>Serum samples were collected from each patient to detect serum multiomics and pancreatic elastase-1 (PE-1). We examine multiomics in the pancreatic tissue collected from the patient who had undergone surgery or the necessary puncture examination and signed the informed consent form.</description>
      <arm_group_label>Controls without pancreatic disease or elevated CA19-9</arm_group_label>
      <arm_group_label>Group of abnormally elevated CA19-9</arm_group_label>
      <arm_group_label>Group of neuroendocrine neoplasm of pancreas</arm_group_label>
      <arm_group_label>Group of solid pseudopapillary tumor of pancreas</arm_group_label>
      <arm_group_label>Individuals at high risk for PDAC</arm_group_label>
      <arm_group_label>Patients with PDAC</arm_group_label>
      <other_name>Multiomics in blood serum or tissue</other_name>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Serum and punctured tissue will be collected.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Pancreatic cancer patients at high risk, patients with pancreatic cancer, benign pancreatic&#xD;
          disease, borderline malignant disease, and abnormal elevation of CA199, as well as patients&#xD;
          with other diseases without pancreatic disease are included. The Pancreatic cancer patients&#xD;
          at high risk are those which are hereditary pancreatic cancer patients at high risk,&#xD;
          chronic pancreatitis, new diabetes mellitus, or PCN pancreatic cystic tumor patients.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Case groups (matching any of the following):&#xD;
  &#xD;
            1. Patients with pancreatic cancer with recognized diagnostic criteria or conclusions.&#xD;
  &#xD;
            2. Patients who are the high-risk group of pancreatic cancer.&#xD;
  &#xD;
            3. Patients with solid pseudo papilloma and neuroendocrine tumors of pancreas with&#xD;
               recognized diagnostic criteria or conclusions.&#xD;
  &#xD;
            4. Patients with other diseases with abnormally elevated CA19-9.&#xD;
  &#xD;
          Control group:&#xD;
  &#xD;
          (1) Patients without pancreatic disease assessed by laboratory tests and imaging&#xD;
          examinations have no CA19-9 elevation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients who are younger than 18 years of age.&#xD;
  &#xD;
            2. Patients with suspected pancreatic malignant lesions but has no confirmed imaging or&#xD;
               pathological diagnosis.&#xD;
  &#xD;
            3. Patients who have not signed informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ning Zhong, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Qilu Hospital of Shandong University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Zhen Li, MD</last_name>
      <phone>18560086106</phone>
      <email>qilulizhen@sdu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ning Zhong</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <zip>250063</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ning Zhong, MD</last_name>
      </contact>
      <contact_backup>
        <last_name>Zhen Li, MD</last_name>
        <phone>18560086106</phone>
        <email>qilulizhen@sdu.edu.cn</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 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>Pancreatic Neoplasms</mesh_term>
      <mesh_term>Neuroendocrine Tumors</mesh_term>
      <mesh_term>Pancreatitis</mesh_term>
      <mesh_term>Pancreatic 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/NCT06041009
  org study id: 2023SDU-QILU-4
  nct id: NCT06041009
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a prospective cohort study. The investigators enroll subjects with pancreatic ductal
        adenocarcinoma (PDAC), individuals at high risk for PDAC, patients with other pancreatic
        diseases, patients with CA19-9 elevation and controls without pancreatic disease. This study
        aims to establish a diagnostic prediction model by using elastase 1, common clinical
        serological examinations, and imaging examinations including endoscopic ultrasonography
        (EUS), and to explore the diagnostic ability of the model in the high-risk population of
        PDAC. Besides, the investigators search for new biomarkers by multi-omics studies of serum
        and pancreatic tissues to further improve the diagnostic performance of this model. In
        conclusion, this study seeks a robust diagnostic prediction model to diagnose PDAC,
        especially early resectable PDAC.
  observational model: Case-Control
  time perspective: Prospective
  measure: The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)
  time frame: 2 years
  description: The diagnostic value of diagnostic model in diagnosing PDAC, especially early resectable PDAC.
  measure: The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)
  time frame: 2 years
  description: The diagnostic value of diagnostic model versus EUS or other imaging examinations combined with diagnostic model in diagnosing PDAC.
  measure: The content of elastase 1
  time frame: 2 years
  description: The content of elastase-1 in cystic fluid and serum are measured (units: ng/dl)
  measure: The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)
  time frame: 2 years
  description: The ability of diagnostic models, multi-omics novel tumor markers, and common tumor markers to distinguish PDAC, benign pancreatic disease, borderline malignant disease, patients with abnormally elevated CA199, and controls without pancreatic disease.
  measure: The diagnostic value (sensitivity, specificity, accuracy, and positive and negative predictive values)
  time frame: 2 years
  description: The diagnostic value of the diagnostic model, new tumor markers of multi-omics, and the common tumor markers to distinguish pancreatic tumors of different sites and sizes.
  arm group label: Patients with PDAC
  arm group label: Individuals at high risk for PDAC
  arm group label: Group of neuroendocrine neoplasm of pancreas
  arm group label: Group of solid pseudopapillary tumor of pancreas
  arm group label: Group of abnormally elevated CA19-9
  arm group label: Controls without pancreatic disease or elevated CA19-9
  intervention type: Diagnostic Test
  intervention name: Pancreatic elastase-1 in blood serum
  description: Serum samples were collected from each patient to detect serum multiomics and pancreatic elastase-1 (PE-1). We examine multiomics in the pancreatic tissue collected from the patient who had undergone surgery or the necessary puncture examination and signed the informed consent form.
  arm group label: Controls without pancreatic disease or elevated CA19-9
  arm group label: Group of abnormally elevated CA19-9
  arm group label: Group of neuroendocrine neoplasm of pancreas
  arm group label: Group of solid pseudopapillary tumor of pancreas
  arm group label: Individuals at high risk for PDAC
  arm group label: Patients with PDAC
  other name: Multiomics in blood serum or tissue
  Serum and punctured tissue will be collected.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ning Zhong, MD
  role: Principal Investigator
  affiliation: Qilu Hospital of Shandong University
  last name: Zhen Li, MD
  phone: 18560086106
  email: qilulizhen@sdu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor
  mesh term: Pancreatic Neoplasms
  mesh term: Neuroendocrine Tumors
  mesh term: Pancreatitis
  mesh term: Pancreatic Diseases
  sharing ipd: No