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

Neoplasms Clinical Trial

— OSPREY  

Official title:

OncoSil Pancreatic Cancer Post-marketing Clinical REgistrY (OSPREY)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04493632
• Other study ID #: OSPREY01
• Status: Recruiting
• Start date: April 12, 2022
• Est. completion date: October 1, 2027

Study information

• Verified date: November 2022
• Source: OncoSil Medical Limited
• Contact: Tom Maher
• Phone: +44 750 4658585
• Email: tom.maher[@]oncosil.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 1, 2027
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Disease
• Digestive System Diseases
• Digestive System Neoplasm
• Digestive System Neoplasms
• Endocrine Gland Neoplasm
• Endocrine Gland Neoplasms
• Endocrine System Diseases
• Gastrointestinal Diseases
• Gastrointestinal Neoplasms
• Neoplasms
• Neoplasms by Site
• Pancreatic Diseases
• Pancreatic Neoplasm
• Pancreatic Neoplasms

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario Insular Materno-Infantil	Las Palmas De Gran Canaria
Spain	Hospital Universitario de Fuenlabrada	Madrid
Spain	Hospital Universitario Doce De Octobre	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Clinica Universidad De Navarra	Pamplona
Spain	Hospital Clinico Universitario De Valladolid	Valladolid
United Kingdom	Hammersmith Hospital	London
United Kingdom	The London Clinic	London

Sponsors (1)

Lead Sponsor	Collaborator
OncoSil Medical Limited

Countries where clinical trial is conducted

Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™
Primary	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.	7 years
Primary	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.	Followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™
Primary	tumour response as demonstrated by target tumour response demonstrated by RECIST 1.1	Target (implanted) tumor response (local and distant)	7 years
Primary	Resection Rates	Surgical resection rates and outcome	7 years