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RecruitingNAINTERVENTIONAL

Study of Lymphatic Dysfunction in Primary and Secondary Lymphedema

This research focuses on lymphedema, a condition where the body's lymphatic system doesn't work properly, leading to swelling, often in the arms or legs. This can happen if you inherit the condition (primary lymphedema) or it can develop after cancer treatment, particularly after lymph nodes are removed (secondary lymphedema). Lymphedema affects many people worldwide and can be very challenging, but at the moment, there's no cure. This study aims to understand if inherited and cancer-related lymphedema, despite looking similar, have different causes at a microscopic level. By taking small skin samples, researchers hope to compare them and find clues that could lead to new and effective treatments in the future.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University Hospital, Toulouse
Enrolment target
60
Start
21 Feb 2024
Estimated completion
01 Feb 2026

What is this study about?

Lymphedema is a condition that causes swelling, usually in an arm or a leg. It happens when your lymphatic system, which is a network of vessels and nodes that carry a fluid called lymph around your body, isn't working as it should. This can lead to a build-up of fluid, which in turn can cause the affected area to become firm and thickened.

There are two main types of lymphedema. 'Primary lymphedema' is rarer and is something you are born with or develops later in life due to a genetic fault. 'Secondary lymphedema' is much more common and often develops after treatments for cancer, especially if lymph nodes have been removed during surgery. Although both types cause swelling, doctors don't fully understand if they are exactly the same underneath, at a microscopic level.

Currently, there isn't a cure for lymphedema, and it can significantly impact a person's daily life. This study aims to carefully compare small samples from people with both primary and secondary lymphedema. By looking closely at these samples, researchers hope to find out if there are important differences in how the body reacts and changes in each type. This deeper understanding could be a crucial first step towards developing new and more effective treatments in the future.

Key takeaways

  • This study aims to understand lymphedema better.
  • It compares inherited lymphedema with lymphedema caused by cancer treatment.
  • Small skin samples (micro-biopsies) will be used for research.
  • The goal is to find clues for new lymphedema treatments.
  • Participants must be 18-75 years old and have lymphedema.

Who may be eligible?

This study is looking for adults aged between 18 and 75 who have either primary lymphedema (the inherited type) or secondary lymphedema that developed after breast cancer treatment. You would need to be living in France and be covered by their social security system.

Important conditions include that you must have been free of cancer for at least three years if your lymphedema is cancer-related, and your body mass index (a measure of your weight compared to your height) should be less than 35. You also need to be receiving ongoing care for your lymphedema and consistently wearing a compression garment on the affected limb.

There are some reasons why you wouldn't be able to join. These include if you have an active infection, certain other health conditions like chronic inflammatory disease, or if you are pregnant or breastfeeding. You also can't take part if you are currently smoking, taking certain medications like strong painkillers or blood thinners, or if you have a known allergy to Betadine.

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 between 18 and 75 years old?
  2. Do you have primary lymphedema or lymphedema after breast cancer treatment?
  3. Are you currently receiving care for your lymphedema?
  4. Do you always wear your compression garment on the affected limb?
  5. Are you free from cancer (if applicable) for more than 3 years?
  6. Do you have any active infections or other serious health conditions?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main thing involved is providing some very small samples of your skin, called micro-biopsies. The study details don't mention how many visits or the total length of time you would be involved, nor do they specify any new medications you would take or any follow-up appointments beyond providing the samples. This information would be discussed in full with you before you agree to take part.

Potential risks and benefits

Taking part in a study like this might not directly benefit you, but the information found could help others with lymphedema in the future by leading to better treatments. The main risk involves the small skin samples, which might cause minor discomfort, bruising, or a small risk of infection, similar to any minor skin procedure. You would be fully informed about these before deciding, and you are free to withdraw from the study at any time without giving a reason, and it would not affect your regular medical care.

Locations (1)

  • Toulouse Hospital
    Verified postcode
    Toulouse, France· Recruiting

Common questions

What is lymphedema?

It's a condition that causes swelling, often in an arm or leg, due to a problem with your body's fluid drainage system (the lymphatic system).

What's the difference between primary and secondary lymphedema?

Primary lymphedema is often inherited or develops on its own, while secondary lymphedema usually happens after cancer treatment, like breast cancer surgery.

What is a micro-biopsy?

It's a procedure where a very tiny sample of your skin is taken for examination under a microscope.

Will taking part cure my lymphedema?

This study is focused on understanding lymphedema better, not on finding an immediate cure for participants. However, the findings could help develop future treatments.

Who is running this study?

This study is a medical research project, but the specific institution running it isn't mentioned in this summary. You would be given this information before joining.

How to find out more

Julie MALLOIZEL-DELAUNAY, MD

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 "Study of Lymphatic Dysfunction in Primary and Secondary Lymp…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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