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Pompe Disease Registry Protocol

This registry is a worldwide program gathering information from people diagnosed with Pompe disease. It keeps an eye on the condition over many years, both for those receiving treatment and those who aren't. By collecting this data, scientists and doctors can learn more about how Pompe disease progresses, how different treatments work, and how to improve care. The information also helps with medicine development and ensures new treatments are safe and effective. It's a key way to help the medical community understand Pompe disease better and ultimately provide the best possible support for patients.

At a glance

Status
Recruiting
Sponsor
Genzyme, a Sanofi Company
Enrolment target
2,000
Start
15 Sep 2004
Estimated completion
31 Jan 2034

What is this study about?

Imagine a big, ongoing notebook filled with information from people all over the world who have Pompe disease. That's essentially what the 'Pompe Disease Registry' is. It’s a worldwide project designed to collect important details about your condition over many years, whether you’re having treatment or not. This helps doctors and researchers understand Pompe disease much better than before.

The main aim is to learn how the disease changes over time in different people. We want to see how it affects daily life, how quickly it might progress, and importantly, how effective treatments are. By gathering all this information, we can give better advice to doctors on how to look after their patients and make sure they get the best possible care.

Ultimately, this registry helps us build a clearer picture of Pompe disease. It helps us understand who gets it, what their journeys are like, and how well current and future treatments, like alglucosidase alfa, are working in the long run. This knowledge is crucial for developing even better ways to manage the condition in the future.

Key takeaways

  • It's a global study collecting information about Pompe disease.
  • It helps doctors understand the disease and its treatments better.
  • Your existing medical records are used, no extra tests or visits.
  • Anyone with a confirmed Pompe diagnosis can join.
  • It contributes to improving care for all Pompe patients.
  • You can stop participating at any time.

Who may be eligible?

To be part of this registry, you need to have a confirmed diagnosis of Pompe disease. This means that doctors have officially found evidence of the condition, either through specific enzyme tests in your blood, skin, or muscle, or by identifying two specific changes in your GAA genes.

If you have this confirmed diagnosis and are willing to sign forms giving your permission for your information to be included, then you are eligible. Your age or sex doesn't matter; anyone with a confirmed Pompe diagnosis can join.

There are no reasons that would stop someone from joining this particular registry study once they meet the diagnosis requirement and give their consent.

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. I have been officially diagnosed with Pompe disease.
  2. My diagnosis is confirmed by specific enzyme tests or gene changes.
  3. I understand that my medical records will be used for this study.
  4. I am willing to sign a consent form to allow my information to be included.
Answer every question to see your result.

What does participation involve?

If you join the registry, you won't be given any new medication or asked to undergo specific medical tests just for the study. Instead, the registry will collect information from your existing medical records over time. This includes details about your Pompe disease, any treatments you receive, and how you are getting on. This is done on an ongoing basis for many years, as long as you wish to be part of it. There are no extra visits or follow-up appointments required beyond your usual medical care.

Potential risks and benefits

Joining the registry doesn't involve any physical risks because it only collects information from your existing medical care, rather than asking you to try new treatments or have extra tests. Your personal information will be kept private. The main benefit is that your information helps doctors and researchers learn more about Pompe disease, which can lead to better care and treatments for all patients, now and in the future. Remember, you can choose to withdraw your information from the registry at any time without giving a reason.

Locations (272)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Alabama at Birmingham- Site Number : 840106
    Verified postcode
    Birmingham, United States· Recruiting
  • Barrow Neurological Institute- Site Number : 840087
    Verified postcode
    Phoenix, United States· Recruiting
  • Phoenix Children's Hospital- Site Number : 840003
    Verified postcode
    Phoenix, United States· Recruiting
  • University of Arizona- Site Number : 840015
    Verified postcode
    Tucson, United States· Recruiting
  • Arkansas Children's Hospital- Site Number : 840109
    Verified postcode
    Little Rock, United States· Recruiting
  • University of Arkansas for Medical Sciences- Site Number : 840113
    Verified postcode
    Little Rock, United States· Recruiting
  • University of California at Irvine- Site Number : 840036
    Verified postcode
    Irvine, United States· Recruiting
  • Loma Linda University- Genetics- Site Number : 840070
    Verified postcode
    Loma Linda, United States· Completed
  • Southern California Permanente Medical Group- Site Number : 840108
    Verified postcode
    Los Angeles, United States· Recruiting
  • USC Health Sciences Center Dept of Genetics- Site Number : 840082
    Verified postcode
    Los Angeles, United States· Completed
  • UCSF Benioff Children's Hospital - Oakland- Site Number : 840029
    Verified postcode
    Oakland, United States· Completed
  • Children's Hospital of Orange County- Site Number : 840074
    Verified postcode
    Orange, United States· Recruiting

Common questions

What is a 'registry'?

A registry is like a large, ongoing database that collects medical information from people with a specific health condition, in this case, Pompe disease. It helps doctors learn more about the condition over time.

Will I get new medicine if I join?

No, this registry doesn't involve giving you new medicines. It simply collects information about your existing medical care and any treatments you are already receiving.

What kind of information will be collected?

Information about your diagnosis, how your Pompe disease affects you, and any treatments you are having will be collected from your medical records.

How long will my information be in the registry?

Your information will be in the registry for an ongoing period, as long as you continue to give your permission. You can withdraw at any time.

Is my personal information safe?

Yes, all your personal information is kept private and handled carefully to protect your identity.

How to find out more

Trial Transparency email recommended (Toll free number for US & Canada)

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

Interested in taking part?

Register your interest

Share your details and the research team for "Pompe Disease Registry Protocol…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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