OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry.

Sponsor

OncoSil Medical Limited (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04493632

Collaborator

(none)

500

Enrollment

65.6

Anticipated Duration (Months)

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

OncoSil Pancreatic Cancer Post-marketing Clinical REgistrY (OSPREY)

Anticipated Study Start Date :

Apr 12, 2022

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Oct 1, 2027

Outcome Measures

Primary Outcome Measures

Safety and tolerability of Device [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 [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 [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 [7 years]
Target (implanted) tumor response (local and distant)
Resection Rates [7 years]
Surgical resection rates and outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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;
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