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RECRUITINGINTERVENTIONAL

CongenItal Naevus Cohort for Longitudinal Evaluation

CIRCLE : CongenItal Naevus Cohort for Longitudinal Evaluation

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This 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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

OTHER

Neurodevelopmental assessment

This assessment will be conducted using the ASQ-3 test. (ASQ-3 stands for Ages and Stages Questionnaires, Third Edition, which is a common screening tool for evaluating developmental progress in young children.)

OTHER

Meeting with the parents

This meeting will evaluate the parents' acceptance of the lesion and their quality of life using the MARKS test (Measure of Acceptance of Skin Marks). The results will provide insights into how the parents perceive the lesion and how it impacts their daily lives.

OTHER

Patient quality of life assessment

Collection of patient quality of life data

Locations (16)

Grasse Hospital
Nice, Alpes-Maritimes, France
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
Nantes University Hospital
Nantes, Loire Atlantique, 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
CHU Lille
Lille, France