<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/NCT04493632</url>
  </required_header>
  <id_info>
    <org_study_id>OSPREY01</org_study_id>
    <nct_id>NCT04493632</nct_id>
  </id_info>
  <brief_title>OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry.</brief_title>
  <acronym>OSPREY</acronym>
  <official_title>OncoSil Pancreatic Cancer Post-marketing Clinical REgistrY (OSPREY)</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>
      The OSPREY Patient Registry has been developed to collect and assess the performance and&#xD;
      safety of the OncoSil™ device when used within the approved indication of unresectable,&#xD;
      locally advanced pancreatic cancer, in combination with gemcitabine-based chemotherapy,&#xD;
      within a real-world observational registry.&#xD;
&#xD;
      The Registry data will provide both complementary and contemporary information to the&#xD;
      existing clinical data across various countries and will form part of the post-market&#xD;
      clinical follow-up activities for OncoSil™. Therefore, the Registry will be implemented only&#xD;
      in countries with regulatory (commercial) approval for the OncoSil™ device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OSPREY is a post-market, global, multicentre, observational, prospective registry in which&#xD;
      data is recorded from patients who undergo OncoSil™ device implantation.&#xD;
&#xD;
      Countries intended for initial commercial distribution include Australia, Belgium, France,&#xD;
      Germany, Italy, Singapore, Spain, &amp; the United Kingdom.&#xD;
&#xD;
      Only patients who are intended to undergo treatment with the OncoSil™ device in the&#xD;
      commercial (sales) setting will participate in this Registry.&#xD;
&#xD;
      Every patient who is prescribed OncoSil™ in the commercial setting will be approached by the&#xD;
      Treating Physician to consent to participate in the OSPREY Patient Registry.&#xD;
&#xD;
      Patients who choose not to consent to participate in the OSPREY Patient Registry will not be&#xD;
      excluded from being treated with the OncoSil™ device.&#xD;
&#xD;
      Five hundred patients (implanted with OncoSil™) will be recruited into the OSPREY Patient&#xD;
      Registry. It is anticipated recruitment will be over a five-year period, subject to the rate&#xD;
      of commercial adoption of the OncoSil™ device in the market.&#xD;
&#xD;
      To adequately collect data relating to the performance and safety of the OncoSil™ device,&#xD;
      data will be collected from patients over a prescribed 12-month period from enrolment, the&#xD;
      cohort is then followed to death or to 24-months post the date of the last enrolled patient&#xD;
      implanted with OncoSil™.&#xD;
&#xD;
      Therefore, the Registry is expected to run for a seven-year period. Relevant observational&#xD;
      data will be collected via medical record review.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 12, 2022</start_date>
  <completion_date type="Anticipated">October 1, 2027</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2025</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>Prospective</time_perspective>
  </study_design_info>
  <target_duration>24 Months</target_duration>
  <primary_outcome>
    <measure>Safety and tolerability of Device</measure>
    <time_frame>Followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™</time_frame>
    <description>The analysis for safety within the real-world setting will be performed. The safety of OncoSil™ is defined by the Adverse Event profile. All safety summaries will be produced for the Intention-To-Treat (ITT) population. Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA). All Adverse Events recorded during the Registry will be listed.&#xD;
Summary tables will be produced for Treatment Emergent Adverse Events (TEAEs). The number and percentage of patients with device-related Adverse Events by system organ class (SOC) and preferred term will be tabulated. Similar summaries will be produced by severity of event (both mild, moderate or severe, CTCAE grade 1-4) and drug and/or device relationship.&#xD;
In addition, summary tables will be produced for serious TEAEs and TEAEs associated with special interest acute/late radiation effects and or withdrawal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Device Implantation Performance</measure>
    <time_frame>7 years</time_frame>
    <description>Safety of the implantation of OncoSil™ within the target tumour will be measured by means of procedure-related Adverse Events. An assessment of the utility of OncoSil™ Implantation will be made and listed appropriately.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™</time_frame>
    <description>Overall survival (OS) is defined as the time from enrolment to the date of death from any cause. Patients who are alive or permanently lost to follow-up at the cut-off date for the analysis will be censored at the last date the patient was known to be alive.&#xD;
Overall Survival (OS) will be analysed at the interim analysis and once all 500 OncoSil™ implanted patients have been followed to death or to 24-months post the date of the last enrolled/treated patient.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>tumour response as demonstrated by target tumour response demonstrated by RECIST 1.1</measure>
    <time_frame>7 years</time_frame>
    <description>Target (implanted) tumor response (local and distant)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Resection Rates</measure>
    <time_frame>7 years</time_frame>
    <description>Surgical resection rates and outcome</description>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Pancreatic Neoplasm</condition>
  <condition>Digestive System Neoplasm</condition>
  <condition>Neoplasms by Site</condition>
  <condition>Neoplasms</condition>
  <condition>Endocrine Gland Neoplasm</condition>
  <condition>Digestive System Disease</condition>
  <condition>Pancreatic Diseases</condition>
  <condition>Endocrine System Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Every patient who is intended to undergo implantation of the OncoSil™ device when used&#xD;
        within the approved indication of unresectable, locally advanced pancreatic cancer, in&#xD;
        combination with gemcitabine-based chemotherapy, in the commercial (sales) setting will be&#xD;
        approached by the Treating Physician to consent to participate in the OSPREY Patient&#xD;
        Registry.&#xD;
&#xD;
        Patients who choose not to consent to participate in the OSPREY Patient Registry will not&#xD;
        be excluded from being treated with the OncoSil™ device.&#xD;
&#xD;
        .&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with confirmed unresectable locally advanced pancreatic cancer (LAPC).&#xD;
&#xD;
          2. Patients who undergo OncoSil™ implantation at an eligible treatment facility.&#xD;
&#xD;
          3. Patients who have completed and signed the Patient Informed Consent Form (PICF) for&#xD;
             the OSPREY Patient Registry.&#xD;
&#xD;
          4. Pancreatic target tumour recommended size of &lt;7 cm (longest diameter) and &lt;110 cc&#xD;
             volume.&#xD;
&#xD;
          5. A clinically acceptable ECOG performance status.&#xD;
&#xD;
          6. Patients ≥ 18 years of age at screening.&#xD;
&#xD;
          7. To commence gemcitabine-based chemotherapy, (per Standard-of-Care are according to the&#xD;
             approved prescribing schedule) post Registry enrolment.&#xD;
&#xD;
          8. Adequate biochemical tests, coagulation profile, haematological, renal, and hepatic&#xD;
             function as determined by the Treating Physician.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient Informed Consent Form (PICF) has not been completed and signed for the OSPREY&#xD;
             Patient Registry.&#xD;
&#xD;
          2. Patients treated with OncoSil™ within an approved interventional clinical study&#xD;
             (company or investigator-sponsored).&#xD;
&#xD;
          3. Evidence of distant metastases based on review of baseline CT scan.&#xD;
&#xD;
          4. More than one primary lesion.&#xD;
&#xD;
          5. In the opinion of the Treating Physician, EUS-directed implantation posing undue&#xD;
             patient 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.&#xD;
&#xD;
          6. Evidence of radiographic invasion into stomach or duodenum (if not certain,&#xD;
             confirmation must be obtained prior to enrolment).&#xD;
&#xD;
          7. In the setting of recent, clinically significant pancreatitis, implantation is not&#xD;
             recommended.&#xD;
&#xD;
          8. Pregnant or intending to commence a pregnancy within 12-months of the intended date of&#xD;
             implantation or breastfeeding.&#xD;
&#xD;
          9. Patients who have a known history of hypersensitivity to silicon or phosphorous, or&#xD;
             any of the OncoSil™ components&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</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, London, UK</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tom Maher</last_name>
    <phone>+44 750 4658585</phone>
    <email>tom.maher@oncosil.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nicole G Gaddi, B.Sc Nursing</last_name>
    <phone>+ 61 (0)428 946 588</phone>
    <email>nicole.gaddi@oncosil.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario Insular Materno-Infantil</name>
      <address>
        <city>Las Palmas De Gran Canaria</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fayna Armas, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ana Garcia, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Fuenlabrada</name>
      <address>
        <city>Madrid</city>
        <zip>28942</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fernando Pereira, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Doce De Octobre</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Maria J Tabuenca, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Eva Martin, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinica Universidad De Navarra</name>
      <address>
        <city>Pamplona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Maria M Rodriguez, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario De Valladolid</name>
      <address>
        <city>Valladolid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Purificacion Rodriguez, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hammersmith Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Harpreet Wasan, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The London Clinic</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zarni Win</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>November 8, 2022</last_update_submitted>
  <last_update_submitted_qc>November 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2022</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 tumor</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>Gemcitabine</keyword>
  <keyword>Nab-paclitaxel</keyword>
  <keyword>Abraxane</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Neoplasms by Site</mesh_term>
    <mesh_term>Digestive System Neoplasms</mesh_term>
    <mesh_term>Gastrointestinal Neoplasms</mesh_term>
    <mesh_term>Endocrine Gland Neoplasms</mesh_term>
    <mesh_term>Digestive System Diseases</mesh_term>
    <mesh_term>Gastrointestinal Diseases</mesh_term>
    <mesh_term>Pancreatic Diseases</mesh_term>
    <mesh_term>Endocrine System 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>


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/NCT04493632
org study id: OSPREY01
nct id: NCT04493632
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The OSPREY Patient Registry has been developed to collect and assess the performance and
      safety of the OncoSil™ device when used within the approved indication of unresectable,
      locally advanced pancreatic cancer, in combination with gemcitabine-based chemotherapy,
      within a real-world observational registry.

      The Registry data will provide both complementary and contemporary information to the
      existing clinical data across various countries and will form part of the post-market
      clinical follow-up activities for OncoSil™. Therefore, the Registry will be implemented only
      in countries with regulatory (commercial) approval for the OncoSil™ device.
OSPREY is a post-market, global, multicentre, observational, prospective registry in which
      data is recorded from patients who undergo OncoSil™ device implantation.

      Countries intended for initial commercial distribution include Australia, Belgium, France,
      Germany, Italy, Singapore, Spain, & the United Kingdom.

      Only patients who are intended to undergo treatment with the OncoSil™ device in the
      commercial (sales) setting will participate in this Registry.

      Every patient who is prescribed OncoSil™ in the commercial setting will be approached by the
      Treating Physician to consent to participate in the OSPREY Patient Registry.

      Patients who choose not to consent to participate in the OSPREY Patient Registry will not be
      excluded from being treated with the OncoSil™ device.

      Five hundred patients (implanted with OncoSil™) will be recruited into the OSPREY Patient
      Registry. It is anticipated recruitment will be over a five-year period, subject to the rate
      of commercial adoption of the OncoSil™ device in the market.

      To adequately collect data relating to the performance and safety of the OncoSil™ device,
      data will be collected from patients over a prescribed 12-month period from enrolment, the
      cohort is then followed to death or to 24-months post the date of the last enrolled patient
      implanted with OncoSil™.

      Therefore, the Registry is expected to run for a seven-year period. Relevant observational
      data will be collected via medical record review.
observational model: Cohort
time perspective: Prospective
measure: Safety and tolerability of Device
time frame: Followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™
description: The analysis for safety within the real-world setting will be performed. The safety of OncoSil™ is defined by the Adverse Event profile. All safety summaries will be produced for the Intention-To-Treat (ITT) population. Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA). All Adverse Events recorded during the Registry will be listed.
Summary tables will be produced for Treatment Emergent Adverse Events (TEAEs). The number and percentage of patients with device-related Adverse Events by system organ class (SOC) and preferred term will be tabulated. Similar summaries will be produced by severity of event (both mild, moderate or severe, CTCAE grade 1-4) and drug and/or device relationship.
In addition, summary tables will be produced for serious TEAEs and TEAEs associated with special interest acute/late radiation effects and or withdrawal.
measure: Device Implantation Performance
time frame: 7 years
description: Safety of the implantation of OncoSil™ within the target tumour will be measured by means of procedure-related Adverse Events. An assessment of the utility of OncoSil™ Implantation will be made and listed appropriately.
measure: Overall Survival
time frame: Followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™
description: Overall survival (OS) is defined as the time from enrolment to the date of death from any cause. Patients who are alive or permanently lost to follow-up at the cut-off date for the analysis will be censored at the last date the patient was known to be alive.
Overall Survival (OS) will be analysed at the interim analysis and once all 500 OncoSil™ implanted patients have been followed to death or to 24-months post the date of the last enrolled/treated patient.
measure: tumour response as demonstrated by target tumour response demonstrated by RECIST 1.1
time frame: 7 years
description: Target (implanted) tumor response (local and distant)
measure: Resection Rates
time frame: 7 years
description: Surgical resection rates and outcome
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Paul J Ross, MRCP, MBBS
role: Principal Investigator
affiliation: Guy's and St Thomas' NHS Foundation Trust, London, UK
last name: Tom Maher
phone: +44 750 4658585
email: tom.maher@oncosil.com
last name: Nicole G Gaddi, B.Sc Nursing
phone: + 61 (0)428 946 588
email: nicole.gaddi@oncosil.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: Spain
country: United Kingdom
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Pancreatic Neoplasms
mesh term: Neoplasms by Site
mesh term: Digestive System Neoplasms
mesh term: Gastrointestinal Neoplasms
mesh term: Endocrine Gland Neoplasms
mesh term: Digestive System Diseases
mesh term: Gastrointestinal Diseases
mesh term: Pancreatic Diseases
mesh term: Endocrine System Diseases
sharing ipd: No