CongenItal Naevus Cohort for Longitudinal Evaluation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-24
SponsorNantes University Hospital
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Neurodevelopmental assessment
Other interventionThis 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.)
Meeting with the parents
Other interventionThis 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.
Patient quality of life assessment
Other interventionCollection of patient quality of life data
Treatment groups
819 Participants
are divided into 2 treatment groupsGroup A: Child with a congenital nevusExperimental treatment 2 interventions
Group B: Legal representativesOther 1 intervention
Trial outcomes
Primary outcomes
1
Determine the prevalence of neurodevelopmental abnormalities in infants and young children with medium to giant congenital nevus, and according to nevus characteristics (size, number), at the age of 3 years.
This assessment will be conducted using the ASQ-3 (Ages and Stages Questionnaires, Third Edition).
Time frame
3 years.Secondary outcomes
1
The occurrence of other neurological abnormalities (early epilepsy, etc.), screening for psychomotor developmental delays.
Time frame
3 years2
The prevalence of neurological abnormalities on MRI (Magnetic Resonance Imaging), both absolutely and according to the characteristics of the congenital nevus.
Time frame
3 years.3
The occurrence of early melanoma or another tumor.
Time frame
3 years.4
The evolution of the clinical characteristics of the congenital nevus (size, color, texture, number of satellites), and associated functional signs (pruritus).
According to the Krengel classification 1 (size, projected adult size, number of satellites) and assessment of color, roughness, hair growth, pruritus/eczematization, and proliferative nodules.
Time frame
3 years.Sponsors and contacts
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Source ClinicalTrials.gov