CongenItal Naevus Cohort for Longitudinal Evaluation

NCT06828822 | Recruiting

• 1 other identifier: RC24_0532
• Study Type: interventional
• Target: 819
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Naevi; Neurodevelopmental Disorder; Congenital Nevus

Keywords

Congenital Nevus; Neurodevelopmental Disorder

Outcome Measures

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).

  3 years.

Secondary Outcomes (10)

• The occurrence of other neurological abnormalities (early epilepsy, etc.), screening for psychomotor developmental delays.

  3 years

• The prevalence of neurological abnormalities on MRI (Magnetic Resonance Imaging), both absolutely and according to the characteristics of the congenital nevus.

  3 years.

• The occurrence of early melanoma or another tumor.

  3 years.

• The evolution of the clinical characteristics of the congenital nevus (size, color, texture, number of satellites), and associated functional signs (pruritus).

  3 years.

• Description of the histopathological characteristics of the congenital nevus (if available) following excision or biopsy.

  3 years.

Study Arms (2)

Child with a congenital nevus

EXPERIMENTAL

Other: Neurodevelopmental assessment; Other: Patient quality of life assessment

Legal representatives

OTHER

Other: Meeting with the parents

Interventions

Neurodevelopmental assessment OTHER

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.)

Child with a congenital nevus

Meeting with the parents OTHER

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.

Legal representatives

Patient quality of life assessment OTHER

Collection of patient quality of life data

Child with a congenital nevus

Eligibility Criteria

• Age: 0 Years - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (16)

Grasse Hospital

Nice, Alpes-Maritimes, 06130, France

NOT YET RECRUITING

Nice University Hospital and Lenval Hospital

Nice, Alpes-Maritimes, 06200, France

NOT YET RECRUITING

Marseille University Hospital

Marseille, Bouches-du-Rhône, 13005, France

NOT YET RECRUITING

Dijon University Hospital

Dijon, Côte-d'Or, 21000, France

NOT YET RECRUITING

La Réunion University Hospital

La Réunion, Département Et Région d'Outre-mer, 97400, France

NOT YET RECRUITING

Brest University Hospital

Brest, Finistère, 29200, France

NOT YET RECRUITING

Bordeaux University Hospital

Bordeaux, Gironde, 33000, France

NOT YET RECRUITING

Toulouse University Hospital

Toulouse, Haute-Garonne, 31300, France

NOT YET RECRUITING

Rennes University Hospital

Rennes, Ille-et-Vilaine, 35000, France

NOT YET RECRUITING

Tours University Hospital

Tours, Indre-et-Loire, France

NOT YET RECRUITING

Nantes University Hospital

Nantes, Loire Atlantique, 44300, France

RECRUITING

Angers University Hospital

Angers, Maine et Loire, 49100, France

NOT YET RECRUITING

Nancy University Hospital

Nancy, Meurthe-et-Moselle, 54000, France

NOT YET RECRUITING

Saint Vincent de Paul Hospital

Lille, Nord, 59000, France

NOT YET RECRUITING

Paris Necker Hospital

Paris, Paris, 75015, France

NOT YET RECRUITING

CHU Lille

Lille, France

NOT YET RECRUITING

MeSH Terms

Conditions

Nevus; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Nevi and Melanomas; Neoplasms by Histologic Type; Neoplasms; Mental Disorders

Central Study Contacts

Research and Innovation Department of Nantes UH

CONTACT

+33253482810; bp-prom-regl@chu-nantes.fr

Hélène AUBERT, M.D.

CONTACT

Helene.AUBERT@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 14, 2025
• Study Start: July 23, 2025
• Primary Completion (Estimated): July 23, 2031
• Study Completion (Estimated): July 23, 2031
• Last Updated: March 9, 2026

Record last verified: 2025-05

Locations

FR (16)