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RecruitingNAINTERVENTIONAL

CongenItal Naevus Cohort for Longitudinal Evaluation

This study focuses on birthmarks called congenital naevi, which are skin marks present at birth that grow with a child. We're looking at children under two with medium to giant sized naevi. We aim to understand: 1. If these birthmarks are linked to brain development issues. 2. Their very low possibility of turning into a type of skin cancer called melanoma. 3. How they affect children and their families emotionally and socially. The goal is to gather information to help doctors make better decisions about how to monitor and treat these birthmarks, improving the lives of children and their families.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Nantes University Hospital
Enrolment target
819
Start
23 Jul 2025
Estimated completion
23 Jul 2031

What is this study about?

You might have a birthmark, or your child might have one, called a congenital naevus. These are skin marks that are there from birth and grow as your child grows. They can look very different from person to person. Sometimes, these birthmarks can be quite large, and there are many questions about the best way to look after them. This study aims to help us understand these birthmarks better, especially the bigger ones.

We want to find out if larger birthmarks might be linked to any developmental differences in children, as this isn't fully understood yet. We also know that there's a very small chance some birthmarks could develop into a more serious skin condition called melanoma, and we want to learn more about this risk, especially for larger birthmarks. Beyond the physical aspects, we recognise that having a visible birthmark can sometimes cause worry for parents and might affect how a child feels about themselves and interacts with others as they grow up. The study will look into these emotional and social effects too.

Right now, doctors don't always agree on the best way to manage medium to giant birthmarks. This study is really important because it will give healthcare professionals clearer guidance on monitoring children with these birthmarks, including whether certain scans are helpful and when surgery might be considered. Ultimately, by learning more, we hope to improve the care and quality of life for children with congenital naevi and support their families.

Key takeaways

  • This study focuses on large birthmarks present from birth (congenital naevi).
  • It aims to improve understanding of how these birthmarks affect a child's development and well-being.
  • The study hopes to create better guidelines for monitoring and treatment.
  • Participation involves regular check-ups and discussions with your family.
  • Your child's ongoing medical care will not be affected regardless of participation.

Who may be eligible?

This study is looking for children who are under two years old and have a medium, large, or giant congenital naevus (a birthmark present from birth). This could be a single birthmark or several. Your child also needs to be eligible for social security in the UK.

For your child to take part, you, as their parent or legal guardian, must agree to them being involved in the study. We won't be able to include children who have very faint marks that aren't usually considered naevi, or children whose families find it difficult to attend yearly follow-up appointments. Also, for practical reasons, if parents don't speak French, we unfortunately won't be able to include the child in this particular study.

The aim is to follow children over time, so it's important that we can keep in touch and see them for check-ups as planned.

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. Is your child under 2 years old?
  2. Does your child have a medium, large, or giant birthmark (congenital naevus)?
  3. Are you, as a parent or legal guardian, able to give consent for your child to join?
  4. Can you commit to possible annual follow-up appointments for your child?
Answer every question to see your result.

What does participation involve?

If your child takes part, it would involve regular visits to the hospital for assessments. These would include a check-up of your child's development, a meeting with you, the parents, to discuss how things are going, and also an assessment of your child's quality of life. This usually involves answering some questions about your child's well-being and how the birthmark affects daily life. The study aims to follow children over several years to understand how congenital naevi change over time and how they impact development and quality of life. The exact number of visits and the full duration would be explained in detail by the study team.

Potential risks and benefits

Participating in this study might offer the benefit of closer monitoring for your child and contributing to a better understanding of congenital naevi, which could improve care for many children in the future. There are no direct medical risks from the assessments themselves, though attending appointments might require travel and time. You are completely free to withdraw your child from the study at any time, for any reason, without it affecting their ongoing medical care.

Locations (16)

  • Grasse Hospital
    Verified postcode
    Nice, France· Not yet recruiting
  • Nice University Hospital and Lenval Hospital
    Verified postcode
    Nice, France· Not yet recruiting
  • Marseille University Hospital
    Verified postcode
    Marseille, France· Not yet recruiting
  • Dijon University Hospital
    Verified postcode
    Dijon, France· Not yet recruiting
  • La Réunion University Hospital
    Verified postcode
    La Réunion, France· Not yet recruiting
  • Brest University Hospital
    Verified postcode
    Brest, France· Not yet recruiting
  • Bordeaux University Hospital
    Verified postcode
    Bordeaux, France· Not yet recruiting
  • Toulouse University Hospital
    Verified postcode
    Toulouse, France· Not yet recruiting
  • Rennes University Hospital
    Verified postcode
    Rennes, France· Not yet recruiting
  • Tours University Hospital
    Verified postcode
    Tours, France· Not yet recruiting
  • Nantes University Hospital
    Verified postcode
    Nantes, France· Recruiting
  • Angers University Hospital
    Verified postcode
    Angers, France· Not yet recruiting

Common questions

What is a congenital naevus?

It's a skin mark or birthmark that a baby is born with, which grows in size as the child gets older.

Will my child receive treatment in this study?

This study focuses on understanding and monitoring, not providing specific treatments. Any treatment decisions would be made with your regular medical team.

What does a 'neurodevelopmental assessment' involve?

It's a gentle check-up to see how your child is developing in areas like movement, speech, and learning.

What is 'patient quality of life assessment'?

This involves asking parents about their child's well-being, how they feel, and how the birthmark affects daily life.

How long will my child be in the study?

The study aims to follow children over several years with regular check-ups, but the exact duration would be discussed with you.

How to find out more

Research and Innovation Department of Nantes UH

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 "CongenItal Naevus Cohort for Longitudinal Evaluation…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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