CongenItal Naevus Cohort for Longitudinal Evaluation (CIRCLE)

Nantes University Hospital (NUH)

Status: Not yet enrolling

Conditions: Naevi; Neurodevelopmental Disorder; Congenital Nevus

Treatments: Other: Neurodevelopmental assessment; Other: Meeting with the parents; Other: Patient quality of life assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT06828822

RC24_0532

Details and patient eligibility

About

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.

Enrollment: 819 estimated patients

Sex: All

Ages: Under 24 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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819 participants in 2 patient groups

Child with a congenital nevus

Experimental group

Treatment:

Other: Patient quality of life assessment

Other: Neurodevelopmental assessment

Legal representatives

Other group

Treatment:

Other: Meeting with the parents