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Study identifier: NCT06828822 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

CongenItal Naevus Cohort for Longitudinal Evaluation

Condition: Naevi · Neurodevelopmental Disorder · Congenital Nevus  ·  Sponsor: Nantes University Hospital

PhaseNA
Planned participants819
Who can joinAll sexes, 0 Years to 24 Months
Healthy volunteersNo

About this study

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…

This description comes directly from the study's public registry record.

Talk to the study team

Research and Innovation Department of Nantes UH  ·  +33253482810  ·  bp-prom-regl@chu-nantes.fr

Hélène AUBERT, M.D.  ·  Helene.AUBERT@chu-nantes.fr

Always discuss trial participation with your own doctor first.

Locations (16)

Grasse HospitalNice, Alpes-Maritimes, FranceNot Yet Recruiting
Nice University Hospital and Lenval HospitalNice, Alpes-Maritimes, FranceNot Yet Recruiting
Marseille University HospitalMarseille, Bouches-du-Rhône, FranceNot Yet Recruiting
Dijon University HospitalDijon, Côte-d'Or, FranceNot Yet Recruiting
La Réunion University HospitalLa Réunion, Département Et Région d'Outre-mer, FranceNot Yet Recruiting
Brest University HospitalBrest, Finistère, FranceNot Yet Recruiting
Bordeaux University HospitalBordeaux, Gironde, FranceNot Yet Recruiting
Toulouse University HospitalToulouse, Haute-Garonne, FranceNot Yet Recruiting
Rennes University HospitalRennes, Ille-et-Vilaine, FranceNot Yet Recruiting
Tours University HospitalTours, Indre-et-Loire, FranceNot Yet Recruiting
Nantes University HospitalNantes, Loire Atlantique, FranceRecruiting
Angers University HospitalAngers, Maine et Loire, FranceNot Yet Recruiting

+ 4 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06828822