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

Официальное название

OncoSil Pancreatic Cancer Post-marketing Clinical REgistrY (OSPREY)

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Safety and tolerability of Device [Срок оценки: Followed to death or to 24-months post the date of the last enrolled patient implanted with OncoSil™]
• Device Implantation Performance [Срок оценки: 7 years]
• Overall Survival [Срок оценки: 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 [Срок оценки: 7 years]
• Resection Rates [Срок оценки: 7 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 7 центров

• Complejo Hospitalario Universitario Insular Materno-Infantil — Las Palmas de Gran Canaria
• Hospital Universitario Ramón y Cajal — Madrid
• Hospital Universitario de Fuenlabrada — Madrid
• Hospital Universitario Doce De Octobre — Madrid
• Hospital Universitario La Paz — Madrid
• Clinica Universidad De Navarra — Pamplona
• Hospital Clinico Universitario De Valladolid — Valladolid

Великобритания · 2 центра

• Hammersmith Hospital — London
• The London Clinic — London

Идентификаторы

NCT: NCT04493632 · OSPREY01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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