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Active not recruitingOBSERVATIONAL

Post-Authorization Long-Term Safety Study of LUTATHERA

This study is investigating the long-term safety of LUTATHERA, a treatment for advanced neuroendocrine tumours that cannot be removed by surgery or have spread. Researchers are collecting information on patients who have already received LUTATHERA to understand any potential side effects that might develop over many years. They will look at medical records from the past and follow up with patients in the future. The main goal is to get a clearer picture of how safe this treatment is in the long run for patients with this specific type of cancer, helping doctors and patients make informed decisions.

At a glance

Status
Active not recruiting
Sponsor
Advanced Accelerator Applications
Enrolment target
1,014
Start
28 Nov 2018
Estimated completion
30 Sep 2027

What is this study about?

This study is designed to understand the long-term safety of a medicine called LUTATHERA. It's used to treat a specific type of cancer known as neuroendocrine tumours, particularly when they are advanced, meaning they can't be surgically removed or have spread to other parts of the body. These tumours are 'well-differentiated' and 'somatostatin receptor positive', which are features doctors look for when deciding on treatment.

When new medicines like LUTATHERA are approved, they're typically well-studied for shorter-term effects. However, it's also important to see if any safety concerns or side effects appear much later, sometimes years after treatment. This study aims to gather that crucial information. By looking at existing patient records and perhaps collecting new information, researchers can identify any potential health issues that might arise over an extended period.

Understanding the long-term safety profile of LUTATHERA is really important. It helps doctors and healthcare providers give the best advice to patients about their treatment options. For patients, knowing more about the potential long-term effects can provide reassurance and help them feel more informed about their care.

Key takeaways

  • This study looks at the long-term safety of LUTATHERA for neuroendocrine tumours.
  • It aims to identify any side effects that might appear over many years after treatment.
  • Data will come from existing medical records of patients who have already received LUTATHERA.
  • The findings will help doctors and patients make informed decisions about treatment.
  • Your identity and medical information will be kept private and confidential.

Who may be eligible?

This study is for adults who have already received LUTATHERA treatment for a specific kind of neuroendocrine tumour. This includes patients whose tumours couldn't be removed by surgery or had spread elsewhere in the body. It doesn't matter how much LUTATHERA you received or why your treatment finished.

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.

  1. Are you an adult aged 18 or over?
  2. Have you been diagnosed with a specific type of neuroendocrine tumour?
  3. Have you previously received treatment with LUTATHERA?
  4. Are you not currently pregnant or suspected to be pregnant?
  5. Do you have good kidney function (your doctor can confirm this)?
Answer every question to see your result.

What does participation involve?

As this study is looking at information from people who have already been treated with LUTATHERA, your participation would mostly involve allowing researchers to look at your existing medical records. This data could come from your past appointments (retrospective data) or from future check-ups (prospective data). This helps them understand any long-term effects of the treatment. It's not anticipated that you would need to attend extra visits or take new medication specifically for this study. The total duration of follow-up for the study will depend on how long researchers need to track the safety information.

Potential risks and benefits

Participating in this study might not offer a direct medical benefit to you, as it focuses on gathering information from past treatments. However, your contribution will greatly help future patients by providing a clearer picture of LUTATHERA's long-term safety. The main risk involves the handling of your personal health information, but strict confidentiality rules will be followed to protect your privacy. You always have the right to withdraw your consent at any time if you decide you no longer wish for your data to be used.

Locations (20)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Banner MD Anderson Cancer Center
    Verified postcode
    Phoenix, United States
  • The Ohio State University Wexner Medical Center
    Verified postcode
    Portland, United States
  • Oregon Health & Sciences University Hospital
    Verified postcode
    Portland, United States
  • Virginia Mason in Seattle
    Verified postcode
    Seattle, United States
  • Novartis Investigative site
    Verified postcode
    Clichy, France
  • Novartis Investigative site
    Verified postcode
    Lyon, France
  • Novartis Investigative site
    Verified postcode
    Villejuif, France
  • Novartis Investigative site
    Verified postcode
    Coimbra, Portugal
  • Novartis Investigative site
    Verified postcode
    Santiago de Compostela, Spain
  • Novartis Investigative site
    Verified postcode
    Majadahonda, Spain
  • Novartis Investigative site
    Verified postcode
    Birmingham, United Kingdom
  • Novartis Investigative site
    Verified postcode
    Cambridge, United Kingdom

Common questions

What is a neuroendocrine tumour?

It's a type of cancer that starts in special cells called neuroendocrine cells, which are found throughout the body. They produce hormones.

What is LUTATHERA?

LUTATHERA is a targeted medicine used to treat certain types of advanced neuroendocrine tumours.

Will I have to take more medicine for this study?

No, this study is about monitoring the long-term effects after you’ve already had LUTATHERA, so no new medication is involved.

How will my personal information be kept private?

Researchers are required to follow strict laws and guidelines to protect your privacy and ensure your medical data is handled confidentially.

What does 'unresectable or metastatic' mean?

It means the cancer cannot be completely removed through surgery (unresectable) or it has spread from where it started to other parts of the body (metastatic).

How to find out more

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

Discussion

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