<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/NCT04449406</url>
  </required_header>
  <id_info>
    <org_study_id>012335QM</org_study_id>
    <nct_id>NCT04449406</nct_id>
  </id_info>
  <brief_title>Early Detection of Pancreatic Adenocarcinoma (PDAC) Using a Panel of Biomarkers</brief_title>
  <acronym>UroPanc</acronym>
  <official_title>Early Detection of Pancreatic Adenocarcinoma (PDAC) Using a Panel of Biomarkers (UroPanc)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen Mary University of London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Liverpool</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pancreatic Cancer Research Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Queen Mary University of London</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>
      Urine and blood samples are being collected from patients with and without diseases of the&#xD;
      pancreas. These samples will be tested with the aim of developing an accurate way of&#xD;
      diagnosing diseases of the pancreas using the results.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main aim of this research study is to establish the accuracy of a urinary biomarker panel&#xD;
      (LYVE1, REG1B, TFF1), and affiliated PancRISK score alone or in combination with plasma&#xD;
      CA19-9 for early detection of pancreatic ductal adenocarcinoma (PDAC).&#xD;
&#xD;
      Samples will be collected from symptomatic individuals with suspected pancreatic cancer, and&#xD;
      asymptomatic subjects at risk of developing PDAC.&#xD;
&#xD;
      The results of urine biomarker and CA19-9 analysis carried out on these samples will be&#xD;
      compared to the imaging and, where available, histopathology data, which will inform the&#xD;
      development of a predictive model to detect PDAC earlier.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of biomarker panel and affiliated risk score</measure>
    <time_frame>Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)</time_frame>
    <description>Test accuracy, as measured by sensitivity/specificity (SN/SP) and positive predictive value/negative predictive value (PPV/NPV).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Accuracy of biomarker panel and affiliated risk score when combined with CA19-9 result</measure>
    <time_frame>Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)</time_frame>
    <description>Test accuracy, as measured by sensitivity/specificity (SN/SP) and positive predictive value/negative predictive value (PPV/NPV).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Economic and social impact of using biomarker panel for PDAC testing</measure>
    <time_frame>Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)</time_frame>
    <description>Stakeholder and health economics analyses of the inclusion of the urine test into the existing diagnostic and surveillance pathways for PDAC.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">3500</enrollment>
  <condition>Pancreatic Ductal Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Individuals at risk of developing PDAC</arm_group_label>
    <description>Symptomatic participants (via direct recruitment to UroPanc and via study/tissue bank(s) i.e. UCL ADEPTs study)&#xD;
Asymptomatic participants (via study/tissue bank(s) i.e. University of Liverpool EUROPAC registry)&#xD;
Medical history, demographic information and concomitant medications information will be collected at baseline, together with blood and urine samples. Urinary biomarkers and plasma CA19-9 will be measured and the results compared with imaging data (and pathology, if it becomes available).</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urine and blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Samples from symptomatic and asymptomatic individuals at risk of PDAC will be provided to&#xD;
        the UroPanc team by collaborating centres via dedicated tissue banks/registries already in&#xD;
        place at UCL (ADEPTS) and the University of Liverpool (EUROPAC).&#xD;
&#xD;
        Symptomatic individuals at risk which are being referred to specialist care by their&#xD;
        general practitioners (GPs) will be recruited to participate in UroPanc when attending&#xD;
        clinics (gastroenterology clinics, endoscopy units and Multidisciplinary Diagnostic Centres&#xD;
        (MDCs)) at a participating study site.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria (Symptomatic patients):&#xD;
&#xD;
          -  Able and willing to give informed consent&#xD;
&#xD;
          -  ≥18 years old&#xD;
&#xD;
          -  Suspected pancreatic diseases with symptoms including, but not limited to, diarrhoea,&#xD;
             back pain, abdominal pain, nausea, vomiting, constipation or new onset diabetes&#xD;
&#xD;
        Exclusion criteria (Symptomatic patients):&#xD;
&#xD;
          -  Current or prior treatment (chemotherapy, radiotherapy, surgical resection, biological&#xD;
             therapy, and immunotherapy) for any malignancy other than basal cell carcinoma within&#xD;
             5 years of enrolment.&#xD;
&#xD;
        Asymptomatic participants will be identified through the EUROPAC registry and will fulfil&#xD;
        EUROPAC's eligibility criteria.&#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>Tatjana Crnogorac-Jurcevic, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen Mary University of London</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>UroPanc Coordinator</last_name>
    <phone>020 7882 8497</phone>
    <email>bci-uropanc@qmul.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>EUROPAC study, University of Liverpool</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>ADEPTS study, University College London</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Imperial College London</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Royal London Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>UroPanc Coordinator</last_name>
      <email>bci-uropanc@qmul.ac.uk</email>
    </contact>
    <investigator>
      <last_name>Patrick Wilson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Radon TP, Massat NJ, Jones R, Alrawashdeh W, Dumartin L, Ennis D, Duffy SW, Kocher HM, Pereira SP, Guarner posthumous L, Murta-Nascimento C, Real FX, Malats N, Neoptolemos J, Costello E, Greenhalf W, Lemoine NR, Crnogorac-Jurcevic T. Identification of a Three-Biomarker Panel in Urine for Early Detection of Pancreatic Adenocarcinoma. Clin Cancer Res. 2015 Aug 1;21(15):3512-21. doi: 10.1158/1078-0432.CCR-14-2467.</citation>
    <PMID>26240291</PMID>
  </reference>
  <reference>
    <citation>Blyuss O, Zaikin A, Cherepanova V, Munblit D, Kiseleva EM, Prytomanova OM, Duffy SW, Crnogorac-Jurcevic T. Development of PancRISK, a urine biomarker-based risk score for stratified screening of pancreatic cancer patients. Br J Cancer. 2020 Mar;122(5):692-696. doi: 10.1038/s41416-019-0694-0. Epub 2019 Dec 20.</citation>
    <PMID>31857725</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>May 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>August 10, 2022</last_update_submitted>
  <last_update_submitted_qc>August 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Biomarker</keyword>
  <keyword>PDAC</keyword>
  <keyword>Pancreatic cancer</keyword>
  <keyword>CA19-9</keyword>
  <keyword>Urine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04449406
org study id: 012335QM
nct id: NCT04449406
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Urine and blood samples are being collected from patients with and without diseases of the
      pancreas. These samples will be tested with the aim of developing an accurate way of
      diagnosing diseases of the pancreas using the results.
The main aim of this research study is to establish the accuracy of a urinary biomarker panel
      (LYVE1, REG1B, TFF1), and affiliated PancRISK score alone or in combination with plasma
      CA19-9 for early detection of pancreatic ductal adenocarcinoma (PDAC).

      Samples will be collected from symptomatic individuals with suspected pancreatic cancer, and
      asymptomatic subjects at risk of developing PDAC.

      The results of urine biomarker and CA19-9 analysis carried out on these samples will be
      compared to the imaging and, where available, histopathology data, which will inform the
      development of a predictive model to detect PDAC earlier.
observational model: Cohort
time perspective: Prospective
measure: Accuracy of biomarker panel and affiliated risk score
time frame: Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)
description: Test accuracy, as measured by sensitivity/specificity (SN/SP) and positive predictive value/negative predictive value (PPV/NPV).
measure: Accuracy of biomarker panel and affiliated risk score when combined with CA19-9 result
time frame: Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)
description: Test accuracy, as measured by sensitivity/specificity (SN/SP) and positive predictive value/negative predictive value (PPV/NPV).
measure: Economic and social impact of using biomarker panel for PDAC testing
time frame: Baseline until completion of standard-of-care diagnostic testing (up to 12 months after enrolment)
description: Stakeholder and health economics analyses of the inclusion of the urine test into the existing diagnostic and surveillance pathways for PDAC.
arm group label: Individuals at risk of developing PDAC
description: Symptomatic participants (via direct recruitment to UroPanc and via study/tissue bank(s) i.e. UCL ADEPTs study)
Asymptomatic participants (via study/tissue bank(s) i.e. University of Liverpool EUROPAC registry)
Medical history, demographic information and concomitant medications information will be collected at baseline, together with blood and urine samples. Urinary biomarkers and plasma CA19-9 will be measured and the results compared with imaging data (and pathology, if it becomes available).
Urine and blood samples
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: Tatjana Crnogorac-Jurcevic, MD, PhD
role: Principal Investigator
affiliation: Queen Mary University of London
last name: UroPanc Coordinator
phone: 020 7882 8497
email: bci-uropanc@qmul.ac.uk
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
country: United Kingdom
citation: Radon TP, Massat NJ, Jones R, Alrawashdeh W, Dumartin L, Ennis D, Duffy SW, Kocher HM, Pereira SP, Guarner posthumous L, Murta-Nascimento C, Real FX, Malats N, Neoptolemos J, Costello E, Greenhalf W, Lemoine NR, Crnogorac-Jurcevic T. Identification of a Three-Biomarker Panel in Urine for Early Detection of Pancreatic Adenocarcinoma. Clin Cancer Res. 2015 Aug 1;21(15):3512-21. doi: 10.1158/1078-0432.CCR-14-2467.
PMID: 26240291
citation: Blyuss O, Zaikin A, Cherepanova V, Munblit D, Kiseleva EM, Prytomanova OM, Duffy SW, Crnogorac-Jurcevic T. Development of PancRISK, a urine biomarker-based risk score for stratified screening of pancreatic cancer patients. Br J Cancer. 2020 Mar;122(5):692-696. doi: 10.1038/s41416-019-0694-0. Epub 2019 Dec 20.
PMID: 31857725
responsible party type: Sponsor
mesh term: Adenocarcinoma
sharing ipd: Undecided