CongenItal Naevus Cohort for Longitudinal Evaluation

Recruiting now · Not applicable

Conditions studied: Naevi, Neurodevelopmental Disorder, Congenital Nevus

In brief

Congenital Nevus (CN) is a pigmented skin lesion present at birth, which grows in size as the child grows. It can vary in appearance and is classified by its size, from small (less than 1.5 cm) to giant (greater than 40 cm). CN is associated with genetic mutations, mainly in the NRAS/BRAF genes. A large CN can lead to several clinical issues, including: Risk of neurological disorders: Large CN can be associated with neurological abnormalities such as neuro-meningeal melanosis, hydrocephalus, or brain malformations. These conditions may cause early neuro-developmental delays. The risk is not well understood and requires further studies. Risk of melanoma: The risk of developing melanoma is higher for a large CN but remains low for smaller ones. Increased monitoring is necessary during the early years for large and giant CN. Psycho-social impact: Parents often experience significant anxiety at birth due to the cancer risk and social stigma. As the child grows, a visible CN may impact their quality of life, particularly socially at school. Management of CN remains controversial, especially for those of medium to giant size or with multiple satellites. There is an urgent need for further research to clarify best practices in monitoring and treatment, including the need for routine brain imaging and criteria for surgical intervention. Ultimately, this study aims to deepen our understanding of CN, its associated neurological and melanoma risks, and the psycho-social challenges it poses, while striving to establish clear, evidence-based guidelines for monitoring and treatment to enhance patient outcomes and quality of life.

Key facts

Study ID

NCT06828822

Run by

Nantes University Hospital

People needed

819

Starts

2025-07-23

Expected to finish

2031-07-23

Last updated by the study team

2026-03-09

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient under 2 years old.
• Patient with a medium, large, or giant congenital nevus (CN) according to the Krengel classification, either single or multiple.
• Patient affiliated with social security.
• Patient whose legal representatives consent to their child's participation in the project.

You may not qualify if…

• Patient with light brown spots or pigmented lesions not classified as nevi.
• Patient for whom It is impossible to establish annual follow-up.
• Patient whose parents do not speak French.

Where it is running

• Nantes University Hospital — Nantes, Loire Atlantique, France (enrolling)
• Nice University Hospital and Lenval Hospital — Nice, Alpes-Maritimes, France
• Marseille University Hospital — Marseille, Bouches-du-Rhône, France
• Dijon University Hospital — Dijon, Côte-d'Or, France
• La Réunion University Hospital — La Réunion, Département Et Région d'Outre-mer, France
• Brest University Hospital — Brest, Finistère, France
• Bordeaux University Hospital — Bordeaux, Gironde, France
• Toulouse University Hospital — Toulouse, Haute-Garonne, France
• Rennes University Hospital — Rennes, Ille-et-Vilaine, France
• Tours University Hospital — Tours, Indre-et-Loire, France
• Angers University Hospital — Angers, Maine et Loire, France
• Nancy University Hospital — Nancy, Meurthe-et-Moselle, France
• Saint Vincent de Paul Hospital — Lille, Nord, France
• Paris Necker Hospital — Paris, Paris, France
• Grasse Hospital — Nice, Alpes-Maritimes, France
• CHU Lille — Lille, France

Full record on ClinicalTrials.gov

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