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Trial record 1 of 25 for:    OSPREY
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OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry. (OSPREY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04493632
Recruitment Status : Not yet recruiting
First Posted : July 30, 2020
Last Update Posted : April 20, 2022
Sponsor:
Information provided by (Responsible Party):
OncoSil Medical Limited

Brief Summary:

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.


Condition or disease
Pancreatic Neoplasm Digestive System Neoplasm Neoplasms by Site Neoplasms Endocrine Gland Neoplasm Digestive System Disease Pancreatic Diseases Endocrine System Diseases

Detailed Description:

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: OncoSil Pancreatic Cancer Post-marketing Clinical REgistrY (OSPREY)
Estimated Study Start Date : April 12, 2022
Estimated Primary Completion Date : December 1, 2025
Estimated Study Completion Date : October 1, 2027

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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™ ]

    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.


  2. Device Implantation Performance [ Time Frame: 7 years ]
    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.

  3. Overall Survival [ Time Frame: Followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™ ]

    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.


  4. tumour response as demonstrated by target tumour response demonstrated by RECIST 1.1 [ Time Frame: 7 years ]
    Target (implanted) tumor response (local and distant)

  5. Resection Rates [ Time Frame: 7 years ]
    Surgical resection rates and outcome



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Every patient who is intended to undergo implantation of the OncoSil™ device when used within the approved indication of unresectable, locally advanced pancreatic cancer, in combination with gemcitabine-based chemotherapy, in the commercial (sales) 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.

.

Criteria

Inclusion Criteria:

  1. Patients with confirmed unresectable locally advanced pancreatic cancer (LAPC).
  2. Patients who undergo OncoSil™ implantation at an eligible treatment facility.
  3. Patients who have completed and signed the Patient Informed Consent Form (PICF) for the OSPREY Patient Registry.
  4. Pancreatic target tumour recommended size of <7 cm (longest diameter) and <110 cc volume.
  5. A clinically acceptable ECOG performance status.
  6. Patients ≥ 18 years of age at screening.
  7. To commence gemcitabine-based chemotherapy, (per Standard-of-Care are according to the approved prescribing schedule) post Registry enrolment.
  8. Adequate biochemical tests, coagulation profile, haematological, renal, and hepatic function as determined by the Treating Physician.

Exclusion Criteria:

  1. Patient Informed Consent Form (PICF) has not been completed and signed for the OSPREY Patient Registry.
  2. Patients treated with OncoSil™ within an approved interventional clinical study (company or investigator-sponsored).
  3. Evidence of distant metastases based on review of baseline CT scan.
  4. More than one primary lesion.
  5. In the opinion of the Treating Physician, EUS-directed implantation posing undue patient risk. This includes:

    • where previous EUS-FNA was considered technically too difficult to perform;
    • imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumour within the pancreas;
    • presence (or significant risk) of varices near to the target tumour.
  6. Evidence of radiographic invasion into stomach or duodenum (if not certain, confirmation must be obtained prior to enrolment).
  7. In the setting of recent, clinically significant pancreatitis, implantation is not recommended.
  8. Pregnant or intending to commence a pregnancy within 12-months of the intended date of implantation or breastfeeding.
  9. Patients who have a known history of hypersensitivity to silicon or phosphorous, or any of the OncoSil™ components

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04493632


Contacts
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Contact: Nicole E Wilson, B.Sc + 61 (0)438 136 148 nicole.wilson@oncosil.com.au
Contact: Nicole G Gaddi, B.Sc Nursing + 61 (0)428 946 588 nicole.gaddi@oncosil.com.au

Sponsors and Collaborators
OncoSil Medical Limited
Investigators
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Principal Investigator: Paul J Ross, MRCP, MBBS Guy's and St Thomas' NHS Foundation Trust, London, UK
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Responsible Party: OncoSil Medical Limited
ClinicalTrials.gov Identifier: NCT04493632    
Other Study ID Numbers: OSPREY01
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: April 20, 2022
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by OncoSil Medical Limited:
Pancreatic Cancer
Pancreas
Metastases
Pancreatic tumor
Unresectable
Locally advanced
Implantable
Radiographic
Device
Phosphorous-32
OncoSil™
Brachytherapy
Gemcitabine
Nab-paclitaxel
Abraxane
Additional relevant MeSH terms:
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Neoplasms
Pancreatic Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Pancreatic Diseases
Endocrine System Diseases