Pancreatic NeoplasmOSPREYNCT04493632
OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry.
An observational study of Pancreatic Neoplasm and Digestive System Neoplasm, run by OncoSil Medical Limited at 9 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pancreatic Neoplasm, Digestive System Neoplasm, Neoplasms by Site
- How many people
- 500 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 12 Apr 2022to 1 Oct 2027
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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. .
Who may be able to join
- Patients with confirmed unresectable locally advanced pancreatic cancer (LAPC).
- Patients who undergo OncoSil™ implantation at an eligible treatment facility.
- Patients who have completed and signed the Patient Informed Consent Form (PICF) for the OSPREY Patient Registry.
- Pancreatic target tumour recommended size of <7 cm (longest diameter) and <110 cc volume.
- A clinically acceptable ECOG performance status.
- Patients ≥ 18 years of age at screening.
- To commence gemcitabine-based chemotherapy, (per Standard-of-Care are according to the approved prescribing schedule) post Registry enrolment.
- Adequate biochemical tests, coagulation profile, haematological, renal, and hepatic function as determined by the Treating Physician.
Who cannot join
- Patient Informed Consent Form (PICF) has not been completed and signed for the OSPREY Patient Registry.
- Patients treated with OncoSil™ within an approved interventional clinical study (company or investigator-sponsored).
- Evidence of distant metastases based on review of baseline CT scan.
- More than one primary lesion.
- 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;
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- 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.
- Evidence of radiographic invasion into stomach or duodenum (if not certain, confirmation must be obtained prior to enrolment).
- In the setting of recent, clinically significant pancreatitis, implantation is not recommended.
- Pregnant or intending to commence a pregnancy within 12-months of the intended date of implantation or breastfeeding.
- Patients who have a known history of hypersensitivity to silicon or phosphorous, or any of the OncoSil™ components
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 2 countries
Spain7 sites, 7 recruiting
- Recruiting
Complejo Hospitalario Universitario Insular Materno-Infantil
Las Palmas de Gran Canaria
Fayna Armas, MD
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
Ana Garcia, MD
- Recruiting
Hospital Universitario de Fuenlabrada
Madrid, 28942
Fernando Pereira, MD
- Not yet recruiting
Hospital Universitario Doce De Octobre
Madrid
Maria J Tabuenca, MD
- Not yet recruiting
Hospital Universitario La Paz
Madrid
Eva Martin, MD
- Recruiting
Clinica Universidad De Navarra
Pamplona
Maria M Rodriguez, MD
- Recruiting
Hospital Clinico Universitario De Valladolid
Valladolid
Purificacion Rodriguez, MD
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
Hammersmith Hospital
London
Harpreet Wasan, MD
- Not yet recruiting
The London Clinic
London
Zarni Win
About this study
Official title: OncoSil Pancreatic Cancer Post-marketing Clinical REgistrY (OSPREY)
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.
Read the 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.
- Conditions
- Pancreatic Neoplasm, Digestive System Neoplasm, Neoplasms by Site, Neoplasms, Endocrine Gland Neoplasm, Digestive System Disease
- Keywords
- Pancreatic Cancer, Pancreas, Metastases, Pancreatic tumor, Unresectable, Locally advanced, Implantable, Radiographic, Device, Phosphorous-32, OncoSil™, Brachytherapy, Gemcitabine, Nab-paclitaxel, Abraxane
- Medical subject headings
- Pancreatic Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Endocrine Gland Neoplasms, Digestive System Diseases, Pancreatic Diseases, Endocrine System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of Device
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.
Measured: Followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™
Device Implantation Performance
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.
Measured: 7 years
Overall Survival
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.
Measured: Followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™
tumour response as demonstrated by target tumour response demonstrated by RECIST 1.1
Target (implanted) tumor response (local and distant)
Measured: 7 years
Resection Rates
Surgical resection rates and outcome
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start12 Apr 2022
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- OncoSil Medical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul J Ross, MRCP, MBBS, Principal investigator, Guy's and St Thomas' NHS Foundation Trust, London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493632
- Sponsor's protocol ID
- OSPREY01
- Acronym
- OSPREY
- Status last verified
- Apr 2024
- First submitted
- 21 Jul 2020
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OncoSil Pancreatic Cancer Post-marketing Clinical REgistrY (OSPREY)
- ClinicalTrials.gov ID
- NCT04493632
- Acronym / sponsor ID
- OSPREY / OSPREY01
- Conditions
- Pancreatic Neoplasm, Digestive System Neoplasm, Neoplasms by Site, Neoplasms, Endocrine Gland Neoplasm, Digestive System Disease
- Keywords
- Pancreatic Cancer, Pancreas, Metastases, Pancreatic tumor, Unresectable, Locally advanced, Implantable, Radiographic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- OncoSil Medical LimitedIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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. .
Key inclusion criteria (8 listed)
- Patients with confirmed unresectable locally advanced pancreatic cancer (LAPC).
- Patients who undergo OncoSil™ implantation at an eligible treatment facility.
- Patients who have completed and signed the Patient Informed Consent Form (PICF) for the OSPREY Patient Registry.
- Pancreatic target tumour recommended size of <7 cm (longest diameter) and <110 cc volume.
- A clinically acceptable ECOG performance status.
Key exclusion criteria (12 listed)
- Patient Informed Consent Form (PICF) has not been completed and signed for the OSPREY Patient Registry.
- Patients treated with OncoSil™ within an approved interventional clinical study (company or investigator-sponsored).
- Evidence of distant metastases based on review of baseline CT scan.
- More than one primary lesion.
- In the opinion of the Treating Physician, EUS-directed implantation posing undue patient risk. This includes:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
tumour response as demonstrated by target tumour response demonstrated by RECIST 1.1
Time frame: 7 years
Target (implanted) tumor response (local and distant)
Resection Rates
Time frame: 7 years
Surgical resection rates and outcome
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul J Ross, MRCP, MBBS principal investigator
Guy's and St Thomas' NHS Foundation Trust, London, UK
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neoplasm and Digestive System Neoplasm, run by OncoSil Medical Limited at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tom Maher (+44 750 4658585, tom.maher@oncosil.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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™). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.