<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/NCT03003078</url>
  </required_header>
  <id_info>
    <org_study_id>ONC01P03</org_study_id>
    <nct_id>NCT03003078</nct_id>
  </id_info>
  <brief_title>A Pilot Study of OncoSil™ Given to Patients With Pancreatic Cancer Treated With FOLFIRINOX or Gemcitabine+Abraxane</brief_title>
  <acronym>PanCO</acronym>
  <official_title>An Open Label, Single Arm Pilot Study of OncoSil™, Administered to Study Participants With Unresectable Locally Advanced Pancreatic Adenocarcinoma, Given in Combination With FOLFIRINOX or Gemcitabine+Nab-paclitaxel Chemotherapies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OncoSil Medical Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>OncoSil Medical Limited</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>
      To evaluate the safety of OncoSil™ in a patient population undergoing standard chemotherapy&#xD;
      treatment for pancreatic cancer. This study has been designed to satisfy regulatory&#xD;
      requirements.&#xD;
&#xD;
      The clinical investigation will be conducted at approximately 15 sites in Australia, the&#xD;
      United Kingdom and Europe (Belgium) involving 40 patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Detailed description&#xD;
&#xD;
      The purpose of this research study is to investigate the safety of an active implantable&#xD;
      (radiological) medical device OncoSil™, when implanted into patients with pancreatic cancer,&#xD;
      in conjunction with Standard of Care (SOC) chemotherapy. OncoSil™, is an experimental&#xD;
      treatment and carries the active treatment &quot;radioactive Phosphorous (32P)&quot; inside inactive&#xD;
      silicon particles. Once implanted, the OncoSil™ Microparticles will stay in the tumour&#xD;
      permanently. The purpose of OncoSil™, is to deliver the action of 32P directly into a&#xD;
      targeted tumour to destroy cancer cells.&#xD;
&#xD;
      40 Patients will be taking part in a single arm open label research study - which means that&#xD;
      everyone in the research study will receive the investigational treatment OncoSil™, plus&#xD;
      their prescribed standard chemotherapy regimen which will be either; FOLFIRINOX (FOLFIRINOX&#xD;
      is the name of a combination of chemotherapy drugs used to treat advanced cancer of the&#xD;
      pancreas) or gemcitabine + nab-paclitaxel (Abraxane).&#xD;
&#xD;
      Endpoints: Primary Endpoint:&#xD;
&#xD;
      • Safety and Tolerability&#xD;
&#xD;
      Secondary Endpoints:&#xD;
&#xD;
      Efficacy&#xD;
&#xD;
        -  Local Disease Control Rate at 16 weeks&#xD;
&#xD;
        -  Local Progression Free Survival (LPFS), within the pancreas&#xD;
&#xD;
        -  Progression Free Survival (PFS), all sites&#xD;
&#xD;
        -  Overall Survival (OS)&#xD;
&#xD;
        -  Body weight&#xD;
&#xD;
        -  Impaired function&#xD;
&#xD;
        -  Pain Scores&#xD;
&#xD;
      The screening period will be performed within a 2 week period, followed by a treatment period&#xD;
      of investigational visits which will occur weekly from Day 0 (Visit 1) until week 12, then 4&#xD;
      weeks later at week 16, and then at 8-weekly intervals until study participants reach&#xD;
      documented progression of disease criteria for both LPFS and PFS which marks the end of study&#xD;
      participation i.e. EOS visit.&#xD;
&#xD;
      An 8-weekly review of medical records will be used to monitor possible device or late&#xD;
      radiation related adverse events, and oncology treatments/procedures administered for up to&#xD;
      12 months post OncoSil™ implantation.&#xD;
&#xD;
      Overall survival will be conducted via 8-weekly medical record reviews until study&#xD;
      participant death, or until 104 weeks post the last study participant enrolled.&#xD;
&#xD;
      Activity (Dose): The intended average absorbed radiation dose per treated tumour is 100 Gy&#xD;
      (+20%).&#xD;
&#xD;
      Risks associated with OncoSil™ and/or implantation procedure&#xD;
&#xD;
      The following adverse events, considered to have a causal relationship with OncoSil™ or&#xD;
      procedure, were recorded during previous clinical studies:&#xD;
&#xD;
        -  Procedure-related pain&#xD;
&#xD;
        -  Abdominal pain and discomfort&#xD;
&#xD;
        -  Lethargy&#xD;
&#xD;
        -  Fever&#xD;
&#xD;
        -  Nausea and vomiting&#xD;
&#xD;
        -  Abnormal liver function tests&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 27, 2017</start_date>
  <completion_date type="Actual">July 31, 2020</completion_date>
  <primary_completion_date type="Actual">July 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety / Tolerability of Device according to CTCAE V4.0</measure>
    <time_frame>Collected from the of signed informed consent until patient death or 104 weeks post last patient enrollment date, whichever is sooner</time_frame>
    <description>as determined by the number of treatment emergent adverse events (TEAEs) evaluated</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Local Progression free survival within the pancreas</measure>
    <time_frame>Assessed from Baseline through to first confirmed CT documentation of local progression within the pancreas, an average of 12 months.</time_frame>
    <description>Central reader review of CT changes throughout study enrolment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival - entire body</measure>
    <time_frame>Assessed from Baseline through to EOS visit - an average of 12 months.</time_frame>
    <description>Central reader review of CT changes throughout study enrolment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>104 weeks post last patient first study visit</time_frame>
    <description>Time to participant death from enrolment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>Assessed from Baseline through to EOS visit, an average of 12 months.</time_frame>
    <description>Recorded body weight at each study visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impaired function</measure>
    <time_frame>Frame: Measured at each study visit for the duration of the study, an average of 12 months</time_frame>
    <description>as measured by changes in the Karnofsky Performance Status from screening</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Scores</measure>
    <time_frame>Measured at each study visit for the duration of the study, an average of 12 months</time_frame>
    <description>As measured at each study visit using the Numerical Rating scale (NRS)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>tumour response</measure>
    <time_frame>Baseline measure from screening period, compared to Week 8 CT result, and then to 8 weekly CT results until local progression is determined, an average of 12 months.</time_frame>
    <description>as demonstrated by target tumour volumetric change (measured by a central reading centre)</description>
  </other_outcome>
  <other_outcome>
    <measure>tumour response</measure>
    <time_frame>As assessed at Week 12 study visit compared to Baseline assessment completed during screening period</time_frame>
    <description>as demonstrated by target tumour FDG-PET parameters (measured by a central reading centre)</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Unresectable Locally Advanced Pancreatic Carcinoma</condition>
  <arm_group>
    <arm_group_label>OncoSil™ plus SOC Chemotherapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>OncoSil™ implanted with concurrent Standard of care Chemotherapy - either FOLFIRINOX or gemcitabine + Abraxane.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OncoSil™</intervention_name>
    <description>The implantation of OncoSil™</description>
    <arm_group_label>OncoSil™ plus SOC Chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically or cytologically proven adenocarcinoma of the pancreas.&#xD;
&#xD;
          2. Unresectable locally advanced pancreatic carcinoma. Patients with technically&#xD;
             resectable tumours (T1-T3) will also be eligible, if they are deemed unresectable due&#xD;
             to medical comorbidities or refusal of surgery.&#xD;
&#xD;
          3. Pancreatic target tumour diameter of ≥ 2.0 cm (shortest axis) to ≤ 6.0 cm (longest&#xD;
             axis), as qualified by the central reading centre.&#xD;
&#xD;
          4. An ECOG Performance Status of 0 to 1 and Karnofsky Performance Status of 80 - 100.&#xD;
&#xD;
          5. Study participants ≥ 18 years of age at screening.&#xD;
&#xD;
          6. To commence first-line standard FOLFIRINOX or gemcitabine+nab-paclitaxel chemotherapy&#xD;
             (per standard of care according to the approved prescribing schedule), within 14 days&#xD;
             post enrolment, with OncoSil™ implantation to occur during the fourth (4th) week of&#xD;
             the first chemotherapy cycle.&#xD;
&#xD;
          7. Provide signed Informed Consent.&#xD;
&#xD;
          8. Willing and able to complete study procedures within the study timelines.&#xD;
&#xD;
          9. Adequate renal function: serum creatinine less than 1.5 x upper limit of normal (ULN).&#xD;
&#xD;
         10. Adequate liver function: serum liver transaminases ≤ 3 × ULN and serum bilirubin&#xD;
&#xD;
             ≤ 1.5 × ULN*.&#xD;
&#xD;
             *For study participants with recent biliary obstruction treated by drainage (e.g.&#xD;
             stent), serum bilirubin of &gt; 1.5 x ULN will be accepted for study entry provided that&#xD;
             serial levels demonstrate clear improvement. In addition, chemotherapy should not be&#xD;
             commenced until serum bilirubin is ≤ 1.5 × ULN.&#xD;
&#xD;
         11. Adequate bone marrow function: white blood cells (WBCs) ≥ 3,000/mm3, absolute&#xD;
             neutrophil count (ANC) ≥ 1,500/mm3, haemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mm3.&#xD;
&#xD;
         12. Life expectancy of at least 3 months at the time of screening as judged by the&#xD;
             investigator.&#xD;
&#xD;
         13. Treated with or eligible to commence prophylactic treatment with a proton-pump&#xD;
             inhibitor prior to implantation, and to continue to receive treatment for at least 6&#xD;
             months post implantation.&#xD;
&#xD;
         14. Not pregnant, and if of childbearing potential, agrees to use adequate birth control&#xD;
             (hormonal or barrier method of birth control or abstinence) prior to study entry and&#xD;
             during the study and agrees not to donate sperm or ova, for the duration of the study&#xD;
             and 12 months post implantation of the investigational device.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Evidence of distant metastases, based on review of baseline CT scan, as determined by&#xD;
             the central reading centre.&#xD;
&#xD;
          2. More than one primary lesion.&#xD;
&#xD;
          3. Any prior radiotherapy or chemotherapy for pancreatic cancer.&#xD;
&#xD;
          4. Use of other investigational agent at the time of screening, or within 30 days or five&#xD;
             half-lives of Screening Visit 1, whichever is longer.&#xD;
&#xD;
          5. Pregnant or lactating.&#xD;
&#xD;
          6. In the opinion of the investigator, EUS directed implantation posing undue study&#xD;
             participant risk. This includes:&#xD;
&#xD;
               -  where previous EUS-FNA was considered technically too difficult to perform;&#xD;
&#xD;
               -  imaging demonstrates multiple collateral vessels surrounding or adjacent to the&#xD;
                  target tumour within the pancreas;&#xD;
&#xD;
               -  presence (or significant risk) of varices near to the target tumour. Note: The&#xD;
                  feasibility of implantation of the target tumour and assessment of risk can be&#xD;
                  conducted at any time between Screening Visit 1 and the implantation date. A&#xD;
                  study participant should be considered for withdrawal prior to and including at&#xD;
                  the time of OncoSil™ treatment, if any of the above risk features become apparent&#xD;
                  following subject screening and/or enrolment.&#xD;
&#xD;
          7. History of malignancy, treated or untreated, within the past five years whether or not&#xD;
             there is evidence of local recurrence or metastases, with the exception of basal cell&#xD;
             carcinoma of the skin and cervical carcinoma in situ.&#xD;
&#xD;
          8. Evidence of radiographic invasion into stomach, duodenum or peritoneum (if not certain&#xD;
             confirmation must be obtained prior to enrolment).&#xD;
&#xD;
          9. A known allergy or history of hypersensitivity to silicon, phosphorous or any of the&#xD;
             OncoSil™ components.&#xD;
&#xD;
         10. Any other health condition that would preclude participation in the study in the&#xD;
             judgment of the investigator.&#xD;
&#xD;
        Note: T1-T3 is determined as per The American Joint Committee on Cancer (AJCC)&#xD;
        tumor/node/metastasis (TNM) classification and staging system for pancreatic cancer&#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>Paul J Ross, MRCP MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guy's and St Thomas' NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Corrimal Cancer Care Clinic, 20-22 Underwood St</name>
      <address>
        <city>Corrimal</city>
        <state>New South Wales</state>
        <zip>2518</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Medical Oncology, Royal North Shore Hospital</name>
      <address>
        <city>St Leonards</city>
        <state>New South Wales</state>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Kinghorn Cancer Centre, St Vincent's Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Crown Princess Mary Cancer Centre, Westmead Hospital</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Gastroenterology and Hepatology, Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Breathing and Sleep -Bowen CentreAustin Health</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Cancer Centre</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3165</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Jules Bordet</name>
      <address>
        <city>Bruxelles</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cambridge Cancer Trials Centre, Addenbrooke's Hospital</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leicester Royal Infirmary</name>
      <address>
        <city>Leicester</city>
        <state>East Midlands</state>
        <zip>LEI 5WW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's and St Thomas' NHS Foundation Trust,</name>
      <address>
        <city>London</city>
        <state>Greater London</state>
        <zip>SE19RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hammersmith Hospital</name>
      <address>
        <city>London</city>
        <zip>W12 0HS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>July 9, 2021</last_update_submitted>
  <last_update_submitted_qc>July 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pancreatic cancer</keyword>
  <keyword>Pancreas</keyword>
  <keyword>metastases</keyword>
  <keyword>pancreatic tumour</keyword>
  <keyword>unresectable</keyword>
  <keyword>locally advanced</keyword>
  <keyword>implantable</keyword>
  <keyword>radiographic</keyword>
  <keyword>device</keyword>
  <keyword>Phosphorous-32</keyword>
  <keyword>OncoSil™</keyword>
  <keyword>brachytherapy</keyword>
  <keyword>FOLFIRINOX</keyword>
  <keyword>gemcitabine</keyword>
  <keyword>nab-paclitaxel</keyword>
  <keyword>Abraxane</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03003078
org study id: ONC01P03
nct id: NCT03003078
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To evaluate the safety of OncoSil™ in a patient population undergoing standard chemotherapy
      treatment for pancreatic cancer. This study has been designed to satisfy regulatory
      requirements.

      The clinical investigation will be conducted at approximately 15 sites in Australia, the
      United Kingdom and Europe (Belgium) involving 40 patients.
Detailed description

      The purpose of this research study is to investigate the safety of an active implantable
      (radiological) medical device OncoSil™, when implanted into patients with pancreatic cancer,
      in conjunction with Standard of Care (SOC) chemotherapy. OncoSil™, is an experimental
      treatment and carries the active treatment "radioactive Phosphorous (32P)" inside inactive
      silicon particles. Once implanted, the OncoSil™ Microparticles will stay in the tumour
      permanently. The purpose of OncoSil™, is to deliver the action of 32P directly into a
      targeted tumour to destroy cancer cells.

      40 Patients will be taking part in a single arm open label research study - which means that
      everyone in the research study will receive the investigational treatment OncoSil™, plus
      their prescribed standard chemotherapy regimen which will be either; FOLFIRINOX (FOLFIRINOX
      is the name of a combination of chemotherapy drugs used to treat advanced cancer of the
      pancreas) or gemcitabine + nab-paclitaxel (Abraxane).

      Endpoints: Primary Endpoint:

      • Safety and Tolerability

      Secondary Endpoints:

      Efficacy

        -  Local Disease Control Rate at 16 weeks

        -  Local Progression Free Survival (LPFS), within the pancreas

        -  Progression Free Survival (PFS), all sites

        -  Overall Survival (OS)

        -  Body weight

        -  Impaired function

        -  Pain Scores

      The screening period will be performed within a 2 week period, followed by a treatment period
      of investigational visits which will occur weekly from Day 0 (Visit 1) until week 12, then 4
      weeks later at week 16, and then at 8-weekly intervals until study participants reach
      documented progression of disease criteria for both LPFS and PFS which marks the end of study
      participation i.e. EOS visit.

      An 8-weekly review of medical records will be used to monitor possible device or late
      radiation related adverse events, and oncology treatments/procedures administered for up to
      12 months post OncoSil™ implantation.

      Overall survival will be conducted via 8-weekly medical record reviews until study
      participant death, or until 104 weeks post the last study participant enrolled.

      Activity (Dose): The intended average absorbed radiation dose per treated tumour is 100 Gy
      (+20%).

      Risks associated with OncoSil™ and/or implantation procedure

      The following adverse events, considered to have a causal relationship with OncoSil™ or
      procedure, were recorded during previous clinical studies:

        -  Procedure-related pain

        -  Abdominal pain and discomfort

        -  Lethargy

        -  Fever

        -  Nausea and vomiting

        -  Abnormal liver function tests
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety / Tolerability of Device according to CTCAE V4.0
time frame: Collected from the of signed informed consent until patient death or 104 weeks post last patient enrollment date, whichever is sooner
description: as determined by the number of treatment emergent adverse events (TEAEs) evaluated
measure: Local Progression free survival within the pancreas
time frame: Assessed from Baseline through to first confirmed CT documentation of local progression within the pancreas, an average of 12 months.
description: Central reader review of CT changes throughout study enrolment
measure: Progression free survival - entire body
time frame: Assessed from Baseline through to EOS visit - an average of 12 months.
description: Central reader review of CT changes throughout study enrolment
measure: Overall survival
time frame: 104 weeks post last patient first study visit
description: Time to participant death from enrolment
measure: Body weight
time frame: Assessed from Baseline through to EOS visit, an average of 12 months.
description: Recorded body weight at each study visit
measure: Impaired function
time frame: Frame: Measured at each study visit for the duration of the study, an average of 12 months
description: as measured by changes in the Karnofsky Performance Status from screening
measure: Pain Scores
time frame: Measured at each study visit for the duration of the study, an average of 12 months
description: As measured at each study visit using the Numerical Rating scale (NRS)
measure: tumour response
time frame: Baseline measure from screening period, compared to Week 8 CT result, and then to 8 weekly CT results until local progression is determined, an average of 12 months.
description: as demonstrated by target tumour volumetric change (measured by a central reading centre)
measure: tumour response
time frame: As assessed at Week 12 study visit compared to Baseline assessment completed during screening period
description: as demonstrated by target tumour FDG-PET parameters (measured by a central reading centre)
arm group label: OncoSil™ plus SOC Chemotherapy
arm group type: Other
description: OncoSil™ implanted with concurrent Standard of care Chemotherapy - either FOLFIRINOX or gemcitabine + Abraxane.
intervention type: Device
intervention name: OncoSil™
description: The implantation of OncoSil™
arm group label: OncoSil™ plus SOC Chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul J Ross, MRCP MBBS
role: Principal Investigator
affiliation: Guy's and St Thomas' NHS Foundation Trust
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Belgium
country: United Kingdom
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
sharing ipd: No