Active not recruitingNAINTERVENTIONAL

National Clinical-biological Prospective Cohort of Incident Cases of Aggressive Fibromatosis (ALTITUDES)

This research wants to create the biggest collection of information about a rare condition called aggressive fibromatosis (AF) in France. AF is a type of growth that can be tricky to treat and often comes back. At the moment, doctors don't have enough clear information to help patients decide on the best treatment. This study will collect detailed information, including tissue samples from biopsies and blood samples, from new patients diagnosed with AF. By doing this, researchers hope to learn more about how AF behaves, why some treatments work better than others, and ultimately improve care for people living with this condition. It's a way to help doctors better answer patient questions and make more informed decisions about treatment.

At a glance

Status

Active not recruiting

Phase

Sponsor

Centre Oscar Lambret

Enrolment target

628

Start

22 Mar 2016

Estimated completion

01 Nov 2030

Aggressive Fibromatosis

What is this study about?

Aggressive fibromatosis, often shortened to AF, is a very rare growth that can happen in the body's connective tissues. It's not a cancer that spreads to other parts of the body, but it can grow quite large and cause problems like pain or affect how parts of the body work. It's most common in people aged 25 to 40 and affects more women than men.

What makes AF particularly challenging is that its behaviour is very unpredictable. For some people, the growth might stay the same, shrink, or even get bigger over time. This makes it hard for doctors to decide on the best way to treat it. Some treatments, like surgery or radiation therapy, can be very serious and might have long-term side effects, and even then, they might not stop the AF from coming back. There's not a lot of strong research to guide treatment decisions right now.

This study, called ALTITUDES, aims to change that. Researchers want to gather a lot of detailed information from new patients with AF in France. By collecting a wide range of information, including samples of the growth itself (from biopsies) and blood samples, they hope to build a much clearer picture of how AF develops and how different people respond to it. This will help doctors and researchers understand the condition better and find more effective and gentler ways to manage it in the future.

Key takeaways

This study focuses on a rare condition called aggressive fibromatosis.
It aims to build the largest collection of patient information and samples in France.
The goal is to better understand the condition and improve future treatments.
Participation involves routine procedures like biopsies and optional blood samples.
It's an observational study, meaning no new medications are being tested.
You can stop participating at any time if you wish.

Who may be eligible?

To be part of this study, you would need to be newly diagnosed with aggressive fibromatosis in France starting from January 1st, 2016. Your diagnosis would need to be officially confirmed by a special French network of experts who check tissue samples, including looking for specific gene changes.

You also need to be a part of the National Health System in France. If you are interested in taking part, you would need to read and sign a consent form, showing you understand the study and agree to participate. For younger patients who are not yet adults, both parents or legal guardians would need to sign the form.

However, you wouldn't be able to join the study if you are held in a place like a prison or if for some reason you are not able to understand and agree to take part, or simply do not wish to.

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.

Were you diagnosed with aggressive fibromatosis in France on or after January 1st, 2016?
Has your diagnosis been confirmed by a special expert network in France?
Are you part of the National Health System in France?
Are you able to understand and sign a consent form for yourself (or your parents for a child)?
Are you not currently under any administrative or legal hold that limits your freedom?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve several steps. You would have a biopsy taken from the aggressive fibromatosis growth, which is a standard procedure to help diagnose the condition. The study would then use this tissue, along with some of your blood samples (if you agree), to create what's called a 'biobank'. This biobank is like a library of samples that researchers can study to learn more about aggressive fibromatosis. You'd also be asked about any pain you might be experiencing. The study duration is not specified in detail, but it focuses on gathering information from new cases.

Potential risks and benefits

Participating in this study might help improve the understanding and future treatments for aggressive fibromatosis, which could benefit patients in the long run. The main procedures involved are ones you would likely undergo as part of your normal care, such as a biopsy. However, any medical procedure carries some small risks, which your doctor can explain. You are free to withdraw from the study at any time without it affecting your medical care.

Locations (39)

Institut de Cancérologie de l'Ouest - Paul Papin
Verified postcode
Angers, France
CHU Angers
Verified postcode
Angers, France
CHU de Besançon
Verified postcode
Besançon, France
Hôpital des Enfants
Verified postcode
Bordeaux, France
Institut Bergonié
Verified postcode
Bordeaux, France
CHU de Caen-Côte de Nacre
Verified postcode
Caen, France
Centre François Baclesse
Verified postcode
Caen, France
Centre Jean Perrin
Verified postcode
Clermont-Ferrand, France
Centre Georges François Leclerc
Verified postcode
Dijon, France
CHU de Grenoble- Hôpital Couple Enfant
Verified postcode
Grenoble, France
Centre Oscar Lambret
Verified postcode
Lille, France
Centre Léon Bérard
Verified postcode
Lyon, France

Common questions

What is aggressive fibromatosis?

It's a rare, non-cancerous growth in connective tissues that can be unpredictable and challenging to treat.

Why is this study important for patients?

It aims to gather more information to help doctors better understand the condition and find clearer, more effective ways to treat it in the future.

Will I have to take new medicine?

No, this study is about collecting information and samples, not testing new medications.

How long will I be in the study?

The study aims to collect information from new patients over time, but it doesn't specify an individual patient's duration.

Can I change my mind after joining?

Yes, you have the right to withdraw from the study at any time, and it won't affect your medical care.