Long-term follow-up of infants with congenital nevus
CIRCLE : CongenItal Naevus Cohort for Longitudinal Evaluation
NA · Nantes University Hospital · NCT06828822
Track children under 2 with medium-to-giant congenital nevi to see if they develop neurological problems, melanoma risk, or psychosocial impacts as they grow.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 819 (estimated) |
| Ages | 0 Years to 24 Months |
| Sex | All |
| Sponsor | Nantes University Hospital (other) |
| Locations | 16 sites (Nice, Alpes-Maritimes and 15 other locations) |
| Trial ID | NCT06828822 on ClinicalTrials.gov |
What this trial studies
This is a prospective cohort that enrolls infants under age 2 who have medium, large, or giant congenital nevi and follows them over time with yearly neurodevelopmental evaluations, parent meetings, and quality-of-life assessments. Clinical data will include lesion classification, genetic findings when available (NRAS/BRAF), and standardized neurological and psychosocial measures. The protocol requires annual follow-up visits at participating French hospitals to monitor for neurological abnormalities, signs of melanoma, and developmental delays. Data will be used to better define risks associated with lesion size and to inform monitoring and counseling practices.
Who should consider this trial
Good fit: Children under 2 years old with medium, large, or giant congenital nevus (single or multiple), whose legal representatives consent and who can attend follow-up and speak French, are ideal candidates.
Not a fit: Children with small light-brown pigmented spots that are not classified as congenital nevi, those unable to commit to annual follow-up, non–French-speaking families, or children older than 2 at enrollment are unlikely to benefit from this cohort.
Why it matters
Potential benefit: If successful, the project could lead to earlier detection of neurological problems or melanoma risk in affected children and improve guidance and support for families.
How similar studies have performed: Prior observational reports have linked large congenital nevi to melanoma and neurocutaneous melanosis, but large prospective longitudinal cohorts in very young children remain limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nice, Alpes-Maritimes and 15 other locations
- Grasse Hospital — Nice, Alpes-Maritimes, France (NOT_YET_RECRUITING)
- Nice University Hospital and Lenval Hospital — Nice, Alpes-Maritimes, France (NOT_YET_RECRUITING)
- Marseille University Hospital — Marseille, Bouches-du-Rhône, France (NOT_YET_RECRUITING)
- Dijon University Hospital — Dijon, Côte-d'Or, France (NOT_YET_RECRUITING)
- La Réunion University Hospital — La Réunion, Département Et Région d'Outre-mer, France (NOT_YET_RECRUITING)
- Brest University Hospital — Brest, Finistère, France (NOT_YET_RECRUITING)
- Bordeaux University Hospital — Bordeaux, Gironde, France (NOT_YET_RECRUITING)
- Toulouse University Hospital — Toulouse, Haute-Garonne, France (NOT_YET_RECRUITING)
- Rennes University Hospital — Rennes, Ille-et-Vilaine, France (NOT_YET_RECRUITING)
- Tours University Hospital — Tours, Indre-et-Loire, France (NOT_YET_RECRUITING)
- Nantes University Hospital — Nantes, Loire Atlantique, France (RECRUITING)
- Angers University Hospital — Angers, Maine et Loire, France (NOT_YET_RECRUITING)
- Nancy University Hospital — Nancy, Meurthe-et-Moselle, France (NOT_YET_RECRUITING)
- Saint Vincent de Paul Hospital — Lille, Nord, France (NOT_YET_RECRUITING)
- Paris Necker Hospital — Paris, Paris, France (NOT_YET_RECRUITING)
- CHU Lille — Lille, France (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Research and Innovation Department of Nantes UH
- Email: bp-prom-regl@chu-nantes.fr
- Phone: +33253482810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Naevi, Neurodevelopmental Disorder, Congenital Nevus