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Observatoire Des Patients Atteints de Laminopathies et Emerinopathies (Observatory for PAtients With Laminopathies and Emerinopathies)

The OPALE study is an observatory for people in France who have rare genetic conditions called laminopathies and emerinopathies. These conditions are caused by changes in specific genes (LMNA and EMD) and can affect muscles, especially the heart. Doctors want to gather detailed health information from people with these conditions, including their genetic test results and how their health changes over time. This will help them to understand the conditions better, find out how often different health problems occur, and identify factors that might predict the disease's course. There are currently no specific treatments to stop or slow down these diseases, so learning more about them is a crucial step towards developing new therapies in the future. Participation is based on having a confirmed genetic change and receiving regular follow-up care in France.

At a glance

Status
Recruiting
Sponsor
Pitié-Salpêtrière Hospital
Enrolment target
800
Start
11 Jul 2013
Estimated completion
11 Jul 2033

What is this study about?

Laminopathies and emerinopathies are a group of unusual conditions caused by tiny changes in our genes, specifically the LMNA and EMD genes. These changes can affect different parts of the body, but most commonly, they impact our muscles, including the heart. Heart problems can, unfortunately, be a serious concern for people with these conditions. Since the 1990s, medical understanding of these diseases has grown a lot, but there's still much to learn about exactly how these gene changes lead to the symptoms people experience.

At the moment, treatments mostly focus on managing symptoms, as there isn't a specific cure or a way to stop the conditions from progressing. That's why studies like OPALE are so important. The OPALE study, which stands for "Observatory for Patients With Laminopathies and Emerinopathies," is gathering detailed health information from people in France who have these conditions. It's like building a comprehensive health record for many patients all in one place, but with all personal details kept private.

The main goals of the OPALE study are to observe how these diseases naturally develop over time, understand how often different health issues (like heart problems or muscle weakness) occur, and identify any patterns or factors that might help predict how a person's condition will progress. By collecting this information carefully, researchers hope to gain a much clearer picture of laminopathies and emerinopathies, which is a vital step towards finding more effective treatments in the future.

Key takeaways

  • It's a study aiming to understand rare genetic muscle/heart conditions.
  • It collects anonymous patient information from existing medical records.
  • No new treatments or tests are involved, just observation.
  • It's for people in France with specific gene changes (LMNA or EMD).
  • Results could help develop better future treatments.
  • Participation is voluntary and confidential.

Who may be eligible?

To be part of this study, you need to meet certain requirements. The most important is having a confirmed genetic change (mutation) in either the LMNA or EMD gene that doctors know causes laminopathy or emerinopathy. This genetic test result would have been provided by your doctor.

You also need to be receiving your regular medical care and check-ups in France. Finally, if you meet these criteria and agree to take part, you'll need to sign a consent form, which shows you understand the study and agree to participate willingly.

You would not be able to join the study if you do not wish to sign the consent form after understanding all the information provided.

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 diagnosed with a laminopathy or emerinopathy.
  2. My diagnosis is confirmed by a genetic test showing a change in the LMNA or EMD gene.
  3. I receive my regular medical care for this condition in France.
  4. I am willing to sign a consent form to allow my information to be used anonymously.
Answer every question to see your result.

What does participation involve?

This study is an "observatory," which means it primarily involves collecting information from your existing medical records and ongoing doctor visits. You won't be asked to take any new medications or undergo any extra tests specifically for the study. Instead, researchers will gather details from your regular check-ups, including genetic test results, information about your heart health, muscle strength, and any other relevant assessments. Your participation involves allowing your medical information (with your identity kept private) to be added to a secure database. There isn't a specific end date for your participation; instead, the registry will continue to collect information as long as you are receiving regular follow-up care and consent to be part of the study.

Potential risks and benefits

There are no direct medical benefits from taking part in this study, as it doesn't involve new treatments or medical interventions. However, the information gathered will be incredibly valuable to researchers, helping them to better understand laminopathies and emerinopathies. This understanding is a crucial step towards developing new and more effective treatments in the future, which could benefit others with these conditions. The main risk is a small chance that your information, although anonymised, could potentially be identified. However, strict measures are in place to protect your privacy and keep your data safe. You are free to withdraw from the study at any time without affecting your medical care.

Locations (28)

  • Centre de référence maladies neuromusculaires,CHU d'Angers
    Verified postcode
    Angers, France· Recruiting
  • CHU Strasbourg
    Verified postcode
    Strasbourg, France· Recruiting
  • CHU Marseille
    Verified postcode
    Marseille, France· Recruiting
  • CHU Caen
    Verified postcode
    Caen, France· Recruiting
  • CHU Brest
    Verified postcode
    Brest, France· Recruiting
  • CHU Nimes
    Verified postcode
    Nîmes, France· Recruiting
  • CHU Bordeaux
    Verified postcode
    Bordeaux, France· Recruiting
  • Centre de Référence de Pathologie NeuroMusculaire, CHU Toulouse
    Verified postcode
    Toulouse, France· Recruiting
  • CHU Montpelleir
    Verified postcode
    Montpellier, France· Recruiting
  • CHU Rennes
    Verified postcode
    Rennes, France· Recruiting
  • CHU Tours
    Verified postcode
    Tours, France· Recruiting
  • Centre de référence des maladies neuromusculaires, CHRU Lille
    Verified postcode
    Lille, France· Recruiting

Common questions

What are laminopathies and emerinopathies?

They are rare genetic conditions caused by changes in specific genes (LMNA and EMD) that can affect muscles, especially the heart.

Is this a trial for a new medicine?

No, this is an 'observatory' study, meaning it collects existing health information from people to understand the conditions better, not to test new treatments.

Do I need to live in France to participate?

Yes, a key requirement is that you must be receiving your regular medical care and follow-ups in France.

Will my personal data be kept private?

Absolutely. All information collected will be kept confidential and your identity will be protected according to strict privacy rules.

What will happen with the information collected?

The information will help researchers understand how these conditions develop, how often problems occur, and what might predict their course, which could lead to better treatments in the future.

How to find out more

Cathy Chikhaoui

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 "Observatoire Des Patients Atteints de Laminopathies et Emeri…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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