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NCT06828822From ClinicalTrials.govRecruiting

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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CongenItal Naevus Cohort for Longitudinal Evaluation | Trialion