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RecruitingNAINTERVENTIONAL

Anatomo-clinico-biological Profiles in Severe Nasal Polyps

This study is about understanding severe nasal polyps, which are common growths that can block your nose. While there are treatments like nasal sprays, surgery, and newer biologic drugs, they don't always work for everyone, and polyps can return. We don't currently know why some people respond better to certain treatments than others. This research aims to find patterns in the polyps themselves, your symptoms, and your body's a biological responses. By linking these factors, we hope to create a way for doctors to predict which treatments, including biologic therapies, will be most effective for individual patients. This could lead to more personalised and successful care for people with severe nasal polyps in the future.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Poitiers University Hospital
Enrolment target
200
Start
03 Jun 2024
Estimated completion
03 Oct 2026

What is this study about?

Imagine your nose and sinus cavities have swelling that causes soft, non-cancerous growths called nasal polyps. These can make it hard to breathe, affect your sense of smell, and generally be quite troublesome. About 2 to 4 in every 100 people in the general population experience these.

Doctors usually first try treatments like corticosteroid nasal sprays to calm the swelling. If these don't work well enough, surgery might be suggested to remove the polyps. However, even after surgery, the polyps can often grow back. More recently, new medicines called biologics have become available, and while they can be very effective, about 1 in 5 patients don't get a full response from them. The problem is, we don't yet have a way to know which treatment will work best for each individual patient.

This study aims to change that. We want to look closely at the polyps themselves, your personal symptoms, and certain biological signals in your body. By putting all this information together, we hope to find clear connections that can predict how well you might respond to different treatments, especially those new biologic medicines. This would help doctors make more informed decisions and guide patients towards the most effective path for managing their nasal polyps, giving you a better chance of successful treatment.

Key takeaways

  • This study investigates severe nasal polyps.
  • It aims to understand why treatments work differently for people.
  • Researchers will look at polyps, symptoms, and biological responses.
  • The goal is to help doctors choose the best treatment for each patient.
  • Participation involves sharing information from your planned surgery.
  • No new treatments are given in this study.

Who may be eligible?

To take part in this study, you need to be an adult aged 18 or older. You should have severe nasal polyps that haven't gotten better with standard medical treatments, and your doctor has decided you need surgery to remove them. You also need to have signed a consent form, showing you understand the study and agree to participate, and have health insurance.

There are some reasons why you wouldn't be able to join. These include if you've already had treatment with biologic medicines or if you've taken certain strong steroid medications in the four weeks before your planned surgery. Also, if you are pregnant or breastfeeding, or considered a 'protected person' (meaning you might not be able to make decisions about your healthcare easily), you wouldn't be able to take part.

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 18 years old or older?
  2. Do you have severe nasal polyps that need surgery?
  3. Have you *not* had any biologic treatment in the past or currently?
  4. Have you *not* taken strong steroid tablets in the last 4 weeks?
  5. Are you able to provide your consent to join the study?
Answer every question to see your result.

What does participation involve?

This study is looking at information collected around your planned surgery for nasal polyps. It's not a study where you try new medicines or treatments. Instead, researchers will be gathering more detailed information about your polyps, your symptoms, and your body's responses during your usual care. This involves collecting samples during your surgery, like small pieces of your polyps, and possibly some blood samples. There won't be any extra visits or follow-up appointments solely for the study beyond what your normal care plan already includes. The total duration of your participation would be linked to the time around your surgery and analysis of the collected samples.

Potential risks and benefits

Taking part in this study won't involve trying out new drugs, so there are no direct risks from experimental treatments. The main benefit is that the information gathered could help future patients with nasal polyps by allowing doctors to better predict which treatments work best. For you personally, there's no direct medical benefit as the study is observational; however, you will be contributing vital information to medical science. Any potential risks are minimal and related to the standard procedures of your surgery or blood tests. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

  • Chu Poitiers
    Verified postcode
    Poitiers, France· Recruiting

Common questions

What are nasal polyps?

Nasal polyps are soft, non-cancerous growths that form inside your nose and sinus passages, often making it hard to breathe.

What are 'biologics'?

Biologics are newer, advanced medications that target specific parts of your immune system to treat conditions like severe nasal polyps.

Will I get a new treatment in this study?

No, this study doesn't involve giving you new treatments. It's about gathering information from your existing care to help understand nasal polyps better.

How does this study help me?

While there's no direct change to your medical care, your involvement will provide important information that could lead to better, more personalised treatments for people with nasal polyps in the future.

What happens to my personal information?

Your personal information will be kept confidential and used only for the purpose of this research, without identifying you personally in any reports.

How to find out more

Florent Carsuzza, Dr

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 "Anatomo-clinico-biological Profiles in Severe Nasal Polyps…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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