<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/NCT03807687</url>
  </required_header>
  <id_info>
    <org_study_id>PAD-R 1101CESC</org_study_id>
    <nct_id>NCT03807687</nct_id>
  </id_info>
  <brief_title>Registry of Pancreatic Disease</brief_title>
  <acronym>PAD-R</acronym>
  <official_title>Registry of Subjects Affected by Pancreatic Disease and Evaluated at the Pancreas Institute of Verona</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliera Universitaria Integrata Verona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Ospedaliera Universitaria Integrata Verona</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 clinical data registry records information about the health status and healthcare&#xD;
      performances received by participants affected by every type of pancreatic disease or&#xD;
      disorder. All data (demographic, clinical, biochemical, radiological, pharmacological,&#xD;
      genetic...) and audio and/or video recording from operative room are collected in order to be&#xD;
      used for prospective or retrospective studies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Anticipated">December 1, 2046</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2046</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>27 Years</target_duration>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>1 year</time_frame>
    <description>Survival from Diagnosis to time of death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative morbidity</measure>
    <time_frame>90 days</time_frame>
    <description>Occurrence of Pancreatic Fistula, Biliary fistula, Enteric fistula, Delayed Gastric Emptying, Hemorrhage or Sepsis.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Pancreatic Diseases</condition>
  <condition>Pancreatic Neoplasms</condition>
  <condition>Pancreatitis</condition>
  <arm_group>
    <arm_group_label>Patient with pancreatic disease</arm_group_label>
    <description>Patients diagnosed with pancreatic disease evaluated at this institution.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Every patient affected by pancreatic disease admitted to General and Pancreatic Surgery&#xD;
        Department of Verona University Hospital from 01/01/1990 to 12/01/2046&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  any type of pancreatic disease: inflammatory and neoplastic (including solid and&#xD;
             cystic lesions)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  physically or mentally inability to provide consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claudio Bassi, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>AOUI Verona</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Erica Secchettin</last_name>
    <phone>+390458126254</phone>
    <email>erica.secchettin@aovr.veneto.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>AOUI Verona</name>
      <address>
        <city>Verona</city>
        <zip>37124</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Erica Secchettin</last_name>
      <phone>+390458126254</phone>
      <email>erica.secchettin@aovr.veneto.it</email>
    </contact>
    <investigator>
      <last_name>Claudio Bassi, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2019</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>Pancreatitis</mesh_term>
    <mesh_term>Pancreatic Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03807687
org study id: PAD-R 1101CESC
nct id: NCT03807687
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This clinical data registry records information about the health status and healthcare
      performances received by participants affected by every type of pancreatic disease or
      disorder. All data (demographic, clinical, biochemical, radiological, pharmacological,
      genetic...) and audio and/or video recording from operative room are collected in order to be
      used for prospective or retrospective studies.
observational model: Cohort
time perspective: Other
measure: Overall survival
time frame: 1 year
description: Survival from Diagnosis to time of death
measure: Postoperative morbidity
time frame: 90 days
description: Occurrence of Pancreatic Fistula, Biliary fistula, Enteric fistula, Delayed Gastric Emptying, Hemorrhage or Sepsis.
arm group label: Patient with pancreatic disease
description: Patients diagnosed with pancreatic disease evaluated at this institution.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Claudio Bassi, Prof
role: Principal Investigator
affiliation: AOUI Verona
last name: Erica Secchettin
phone: +390458126254
email: erica.secchettin@aovr.veneto.it
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
mesh term: Pancreatitis
mesh term: Pancreatic Diseases