An interventional study of Neurodevelopmental assessment and Meeting with the parents in Naevi, Neurodevelopmental Disorder and Congenital Nevus, sponsored by Nantes University Hospital. Recruiting at 16 sites in France. Open to participants aged 0 Years to 24 Months. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Screening
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.
47 studies on the registry are indexed under Nevus; 9 are open to participants now.
This study's planned enrollment of 819 is above the median of 100 across 19 interventional studies indexed under Nevus.
Browse Nevus studies →Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: Neurodevelopmental assessment · Other: Patient quality of life assessment
Other: Meeting with the parents
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.)
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.
Collection of patient quality of life data
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.
The occurrence of other neurological abnormalities (early epilepsy, etc.), screening for psychomotor developmental delays.
Time frame: 3 years
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.
The occurrence of early melanoma or another tumor.
Time frame: 3 years.
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.
Description of the histopathological characteristics of the congenital nevus (if available) following excision or biopsy.
If an excision or biopsy is performed, it will be possible to provide the histopathological characteristics of the congenital nevus (CN).
Time frame: 3 years.
Description of the molecular characteristics of the congenital nevus (if available) following excision or biopsy.
If an excision or biopsy is performed, it will be possible to provide the molecular characteristics of the congenital nevus (CN).
Time frame: 3 years.
Parental satisfaction of cares management and surgery.
Parental satisfaction with the management and surgery, if performed, and evaluation of the patient's satisfaction with the intervention using a Visual Analog Scale (VAS).
Time frame: 3 years.
Lesion acceptance and quality of life.
The parents' acceptance of the lesion and their quality of life will be evaluated 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.
Time frame: 3 years.
Identification of factors influencing the clinical care pathway and their correlation on health outcomes.
Time frame: 3 years.
Identification of the patient's well-being using the Cartoon CDLQI test.
The Cartoon Children's Dermatology Life Quality Index (Cartoon CDLQI) is a version of the Children's Dermatology Life Quality Index (CDLQI) designed to make assessing the quality of life in children with skin diseases more engaging and accessible for younger children. (Scale from 1 to 4 ; with 4 being the worst outcome ( "a lot" ) and 1 being the best ("not at all").
Time frame: 3 years.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Jul 2031, 72 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.