Long-term follow-up of infants with congenital nevus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Research and Innovation Department of Nantes UH
• Email: bp-prom-regl@chu-nantes.fr
• Phone: +33253482810

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.