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NCT06828822 | NOT YET RECRUITING | Naevi

CongenItal Naevus Cohort for Longitudinal Evaluation
Sponsor:

Nantes University Hospital

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.

Condition or disease

Naeci

Neurodevelopmental Disorder

Congenital Nevus

Intervention/treatment

Neurodevelopmental assessment

Meeting with the parents

Patient quality of life assessment

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 819 participants
Masking : NONE
Primary Purpose : SCREENING
Official Title : CIRCLE : CongenItal Naevus Cohort for Longitudinal Evaluation
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2031-06-01
Estimated Study Completion Date : 2031-06-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 0 Years to 24 Months
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
CongenItal Naevus Cohort for Longitudinal Evaluation

Location Details

NCT06828822

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

France, Loire Atlantique

Nantes University Hospital

Nantes, Loire Atlantique, France, 44300