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CongenItal Naevus Cohort for Longitudinal Evaluation

RecruitingNAAges 0 Years - 24 MonthsAllNantes University Hospital
NCT06828822 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 anx

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

  • Neurodevelopmental assessment
  • Meeting with the parents
  • Patient quality of life assessment
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Where

16 sites
Grasse Hospital
Nice, France
Nice University Hospital and Lenval Hospital
Nice, France
Marseille University Hospital
Marseille, France
Dijon University Hospital
Dijon, France
La Réunion University Hospital
La Réunion, France
Brest University Hospital
Brest, France
Bordeaux University Hospital
Bordeaux, France
Toulouse University Hospital
Toulouse, France

…and 8 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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