CongenItal Naevus Cohort for Longitudinal Evaluation
CIRCLE : CongenItal Naevus Cohort for Longitudinal Evaluation
- Naevi
- Neurodevelopmental Disorder
- Congenital Nevus
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Nantes University Hospital
- Enrolment target
- 819
- Started
- 23 July 2025
- Main results due
- 23 July 2031
- Study sites
- 16
- Registry updated
- 24 September 2026
Can you take part?
- Ages 0 years to 24 months.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(16)
Grasse Hospital
Nice, Alpes-Maritimes, France
Recruiting
Nice University Hospital and Lenval Hospital
Nice, Alpes-Maritimes, France
Recruiting
Marseille University Hospital
Marseille, Bouches-du-Rhône, France
Recruiting
Dijon University Hospital
Dijon, Côte-d'Or, France
Recruiting
La Réunion University Hospital
La Réunion, Département Et Région d'Outre-mer, France
Recruiting
Brest University Hospital
Brest, Finistère, France
Recruiting
Bordeaux University Hospital
Bordeaux, Gironde, France
Recruiting
Toulouse University Hospital
Toulouse, Haute-Garonne, France
Recruiting
Rennes University Hospital
Rennes, Ille-et-Vilaine, France
Recruiting
Tours University Hospital
Tours, Indre-et-Loire, France
Recruiting
Nantes University Hospital
Nantes, Loire Atlantique, France
Recruiting
Angers University Hospital
Angers, Maine et Loire, France
Recruiting
Nancy University Hospital
Nancy, Meurthe-et-Moselle, France
Recruiting
Saint Vincent de Paul Hospital
Lille, Nord, France
Recruiting
Paris Necker Hospital
Paris, Paris, France
Recruiting
CHU Lille
Lille, France
Recruiting
Showing 16 of 16 sites. 16 of the 16 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06828822. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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