RecruitingOBSERVATIONAL

A Post-Authorisation Safety Study Patient Registry of Patients With Neuroblastoma Being Treated With Dinutuximab Beta

This study is a registry for children and teenagers with a type of cancer called neuroblastoma who are being treated with a medicine called dinutuximab beta. It's not a trial where doctors try out new treatments, but rather observes what happens in real life after the medicine has already been approved for use. The main goal is to collect information about how safe and effective dinutuximab beta is over time. Researchers will be looking at things like how long patients live, how much pain they experience, and if they have any side effects like nerve problems, vision changes, or heart issues. This helps to build a clearer picture of the medicine's long-term impact for patients in the UK and other countries.

At a glance

Status

Recruiting

Sponsor

RECORDATI GROUP

Enrolment target

125

Start

30 Sep 2019

Estimated completion

15 Jun 2032

Neuroblastoma

What is this study about?

Neuroblastoma is a type of cancer that usually affects young children. It's the most common solid cancer that starts outside the brain in children, and many are diagnosed before they turn five. Often, when it's found, the cancer has already spread or is considered high-risk. Despite new and better treatments, including strong chemotherapy, the outlook for these children can still be challenging.

Dinutuximab beta is a special antibody medicine. Think of antibodies as tiny scouts in your body that can identify and fight off certain unwanted cells. In this case, dinutuximab beta is designed to find and attach to neuroblastoma cancer cells. Once it attaches, it helps your body's immune system destroy these cancer cells. This medicine has already been studied in clinical trials and is approved for use.

This particular study isn't a new experiment with dinutuximab beta. Instead, it's a 'registry,' which means it collects information from many different patients who are already receiving the medicine as part of their standard care. It's like keeping a detailed diary for many patients to understand how the medicine works in the real world, outside of a strictly controlled trial. Researchers want to learn more about its long-term effects, including survival rates, how it affects pain, and if there are any specific side effects over time. This helps doctors and patients make informed decisions about treatment.

Key takeaways

This study helps understand standard treatment for neuroblastoma in children and teenagers.
It's a registry, not a trial testing a new medicine.
Information is collected on how safe and effective dinutuximab beta is over the long term.
Participation involves sharing medical information from your regular appointments.
You won't receive extra tests or treatments by joining.
Your information helps improve care for future patients.

Who may be eligible?

This study is for children and teenagers aged between 1 and 18 years old.

You might be able to take part if you have a high-risk form of neuroblastoma and are starting treatment with dinutuximab beta. This could be the standard version of the medicine that your doctor would prescribe, or if you're taking part in a different clinical trial where the dinutuximab beta is given according to standard approved practices.

To join, you (or your parent/guardian) must agree to be part of the registry and be willing to have your health information followed for up to 10 years. You wouldn't be able to join if you're receiving dinutuximab beta in another clinical trial where the medicine is being used in a way that isn't approved for general use in your country, or if you're not happy to have your information tracked for that length of time.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 1 and 18 years old?
Do you have high-risk neuroblastoma?
Are you starting treatment with dinutuximab beta (the standard, approved medicine)?
Are you willing to have your health followed for up to 10 years?
Are you happy for your medical information to be used for research?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't be given any new or experimental treatments. You'll simply be receiving dinutuximab beta as part of your regular care for neuroblastoma. The study team will then collect information about your health over time, without influencing your treatment choices. This will involve gathering details about your medical history, how you respond to the medicine, any side effects you might experience, and your general well-being. This information will be collected from your medical records during your regular hospital visits. The study plans to follow participants for up to 10 years to understand the long-term effects of dinutuximab beta.

Potential risks and benefits

Taking part in this study doesn't involve any new medical procedures or treatments, so there aren't any direct medical benefits beyond the standard care you'd receive. However, by sharing your information, you'll be helping researchers and doctors learn more about dinutuximab beta. This knowledge can improve understanding for future patients with neuroblastoma. As this is an observational study, there are no additional medical risks beyond those associated with your standard treatment. Your participation is entirely voluntary, and you are free to withdraw from the registry at any time without it affecting your medical care.

Locations (13)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

St. Anna Kinderkrebsforschung
Verified postcode
Vienna, Austria· Active not recruiting
Centre Oscar Lambret
Verified postcode
Lille, France· Recruiting
Hôpital de la Timone, Hôpital des Enfants
Verified postcode
Marseille, France· Recruiting
Institut Curie
Verified postcode
Paris, France· Active not recruiting
Institut Gustave Roussy
Verified postcode
Villejuif, France· Recruiting
Charité Berlin
Verified postcode
Berlin, Germany· Recruiting
Universitätsmedizin Greifswald
Verified postcode
Greifswald, Germany· Recruiting
IRCCS Istituto Giannina Gaslini
Verified postcode
Genova, Italy· Recruiting
Uniwersytecki Szpital Dziecięcy
Verified postcode
Krakow, Poland· Recruiting
Hospital Universitario y Politecnico La Fe Avenida Fernando Abril Martorell
Verified postcode
Valencia, Spain· Recruiting
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Verified postcode
Newcastle upon Tyne, United Kingdom· Recruiting
Birmingham Children's Hospital
Verified postcode
Birmingham, United Kingdom· Active not recruiting

Common questions

What is neuroblastoma?

Neuroblastoma is a type of cancer that usually affects very young children and often starts in nerve tissue outside of the brain.

What is dinutuximab beta?

It's a special antibody medicine that helps your body's immune system find and destroy neuroblastoma cancer cells.

Is this a new treatment trial?

No, this is a 'registry' where doctors collect information on patients already receiving dinutuximab beta as part of their regular care. It's not testing a new treatment.

How long will I be followed?

The study plans to follow your health information for up to 10 years to understand the long-term effects of the medicine.

Will my treatment change if I join?

No, joining this study will not change your medical treatment. You will continue to receive the care your doctor recommends.

How to find out more

Jose-Luis Garcia

PASS@eusapharma.com +34 663 36 34 24 Official trial record

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