RecruitingOBSERVATIONAL

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

The OSPREY Registry is a study that collects information from patients who are receiving a treatment called OncoSil™ for locally advanced pancreatic cancer. These are patients whose cancer cannot be removed by surgery. OncoSil™ is used alongside gemcitabine-based chemotherapy. The study aims to understand how well the OncoSil™ device works and if it has any side effects during routine hospital care, as it's already approved for use. This information will help doctors understand its performance in a real-world setting. It's an observational study, meaning patients receive their usual care, and data is collected from their medical records without additional procedures just for the study.

At a glance

Status

Recruiting

Sponsor

OncoSil Medical Limited

Enrolment target

500

Start

12 Apr 2022

Estimated completion

01 Oct 2027

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

What is this study about?

The OSPREY study is a registry designed to keep an eye on a treatment called OncoSil™ after it has become available for patient use. It focuses on individuals in the UK and other countries who have locally advanced pancreatic cancer that cannot be removed by surgery. The OncoSil™ device is used together with a type of chemotherapy called gemcitabine. This study aims to gather important information about how the OncoSil™ device performs and whether any side effects occur when it's used in day-to-day medical practice.

This registry is important because while new treatments undergo strict testing before they get approved, it's also valuable to see how they work in a wider group of patients under normal care conditions. The OSPREY Registry will collect information from medical records to add to what we already know from previous studies. This helps doctors and healthcare providers understand the treatment better in a real-world setting.

Participation in this study is completely voluntary and only applies to patients who are already going to be treated with the OncoSil™ device as part of their standard care. It will involve collecting information over a period of up to 24 months, with around 500 patients expected to join across various hospitals. The overall registry is expected to run for about seven years.

Key takeaways

The OSPREY Registry collects real-world data on a pancreatic cancer treatment called OncoSil™.
It's for people with locally advanced pancreatic cancer that cannot be surgically removed.
Participation is voluntary and involves no extra medical procedures, just data collection from your records.
The study helps doctors understand how OncoSil™ works in everyday practice.
Your decision whether or not to participate will not affect your medical care.
The registry aims to include 500 patients and will run for about seven years.

Who may be eligible?

To be considered for this study, you would need to have locally advanced pancreatic cancer that cannot be surgically removed, and your doctor must have recommended treatment with the OncoSil™ device at a hospital that is part of this study. You also need to be at least 18 years old and generally well enough for treatment, as assessed by your doctor. The tumour should be a certain size – generally less than 7cm in its longest diameter or less than 110 cubic centimetres in volume.

There are also some specific medical requirements, such as having good blood test results for organs like your kidneys and liver, and that you are planning to receive gemcitabine-based chemotherapy after joining the study. You cannot be pregnant or breastfeeding, or planning a pregnancy within 12 months of implantation. Also, if you have a known allergy to silicon or phosphorus or other materials in the OncoSil™ device, you wouldn't be able to participate.

You would not be able to join the OSPREY Registry if your cancer has spread to distant parts of your body, or if you have more than one main tumour. Also, if your doctor believes that implanting the OncoSil™ device would be too risky for you, perhaps due to previous difficulties with similar procedures or if there are many blood vessels near the tumour, you wouldn't be eligible. Recent, significant inflammation of the pancreas would also rule out participation.

Quick self-check

Do you have pancreatic cancer that is locally advanced and cannot be removed by surgery?
Has your doctor recommended treatment with the OncoSil™ device?
Are you 18 years of age or older?
Are you planning to receive gemcitabine-based chemotherapy after joining the study?
Do you meet the overall health requirements for treatment, as assessed by your doctor?
Are you not pregnant, breastfeeding, or planning a pregnancy within the next 12 months?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in the OSPREY Registry, you won't be asked to do anything extra beyond your standard medical care. Your doctor will discuss the study with you, and if you agree, you'll sign a consent form. All the information collected for the study will come from your existing medical records, so there will be no additional visits, tests, or procedures specifically for the registry. You will receive the OncoSil™ device as planned with your chemotherapy. Data will be collected for up to 12 months after you join, and your progress will be followed for up to 24 months after the last patient has joined the study. You are free to withdraw your consent to participate in the registry at any time, and this will not affect your medical treatment.

Potential risks and benefits

Participating in the OSPREY Registry itself involves no direct medical risks, as it only collects information from your routine care. The benefits are primarily for future patients, as the information gathered will help doctors better understand the OncoSil™ treatment in a real-world setting. It's important to remember that this study is for gathering information, not providing treatment decisions; your treatment will be decided by your treating doctor. You have the right to withdraw from the registry at any time without affecting your medical care.

Locations (9)

Complejo Hospitalario Universitario Insular Materno-Infantil
Las Palmas de Gran Canaria, Spain· Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Spain· Recruiting
Hospital Universitario de Fuenlabrada
Madrid, Spain· Recruiting
Hospital Universitario Doce De Octobre
Madrid, Spain· Not yet recruiting
Hospital Universitario La Paz
Madrid, Spain· Not yet recruiting
Clinica Universidad De Navarra
Pamplona, Spain· Recruiting
Hospital Clinico Universitario De Valladolid
Valladolid, Spain· Recruiting
Hammersmith Hospital
London, United Kingdom· Not yet recruiting
The London Clinic
London, United Kingdom· Not yet recruiting

Common questions

What is the OncoSil™ device?

The OncoSil™ device is a treatment used for locally advanced pancreatic cancer that often can't be surgically removed. It's used in combination with chemotherapy.

Do I have to participate in the OSPREY Registry?

No, participating is completely voluntary. Your decision will not affect your medical treatment with the OncoSil™ device.

What does 'observational registry' mean?

It means the study simply observes and collects information from your standard medical care; no extra tests or procedures are done just for the study.

How long will I be followed in the study?

Information will be gathered from your medical records for up to 12 months after you join, and your progress followed for up to 24 months after the last patient has joined the study.

Will my personal data be kept private?

Yes, all data collected for the registry will be handled with strict confidentiality and in line with data protection regulations.

How to find out more

Tom Maher

tom.maher@oncosil.com +44 750 4658585 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.