RecruitingNot ApplicableNCT06828822

CongenItal Naevus Cohort for Longitudinal Evaluation

CIRCLE : CongenItal Naevus Cohort for Longitudinal Evaluation


Sponsor

Nantes University Hospital

Enrollment

819 participants

Start Date

Jul 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 0 YearsMax Age: 24 Months

Plain Language Summary

Simplified for easier understanding

This study is building a long-term tracking database (cohort) of children born with medium, large, or giant congenital nevi — large pigmented birthmarks present from birth. The goal is to follow these children over time to better understand how these birthmarks change and to monitor for any complications. **You may be eligible if...** - Your child is under 2 years old - Your child has a medium, large, or giant congenital nevus (a significant pigmented birthmark present since birth) - Your child is affiliated with the social security system - You (as a legal guardian) consent to your child's participation **You may NOT be eligible if...** - Your child's pigmented skin lesion is not classified as a true nevus - It is not possible to schedule annual follow-up visits - The child's parents do not speak French Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNeurodevelopmental 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.)

OTHERMeeting 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.

OTHERPatient 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

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NCT06828822


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