CongenItal Naevus Cohort for Longitudinal Evaluation
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Dziecko poniżej 2 lat życia
- •Znamię skórne średnie, duże lub bardzo duże, pojedyncze lub wielokrotne
- •Rodzina ubezpieczona w systemie ubezpieczeń społecznych
- •Rodzice wyrażają zgodę na udział dziecka w badaniu
✗ Disqualifies
- •Jasnobrązowe plamki lub przebarwienia nierozpoznane jako znamiona
- •Niemożliwość regularnych wizyt kontrolnych co roku
- •Rodzice nie mówiący po francusku
Simplified criteria — AI translation
Trial details
- Minimum age
- 0 Years
- Maximum age
- 24 Months
- Last updated (source)
- September 24, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (16)
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
Rennes University Hospital
Rennes, France
Tours University Hospital
Tours, France
Nantes University Hospital
Nantes, France
Angers University Hospital
Angers, France
Nancy University Hospital
Nancy, France
Saint Vincent de Paul Hospital
Lille, France
Paris Necker Hospital
Paris, France
CHU Lille
Lille, France
Trial contact
Research and Innovation Department of Nantes UH
Hélène AUBERT, M.D.
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/1/2026.
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