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CIRCLE : CongenItal Naevus Cohort for Longitudinal Evaluation

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 2
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Angers University Hospital
NOT_YET_RECRUITING
Angers
Bordeaux University Hospital
NOT_YET_RECRUITING
Bordeaux
Brest University Hospital
NOT_YET_RECRUITING
Brest
Dijon University Hospital
NOT_YET_RECRUITING
Dijon
La Réunion University Hospital
NOT_YET_RECRUITING
La Réunion
CHU Lille
NOT_YET_RECRUITING
Lille
Saint Vincent de Paul Hospital
NOT_YET_RECRUITING
Lille
Marseille University Hospital
NOT_YET_RECRUITING
Marseille
Nancy University Hospital
NOT_YET_RECRUITING
Nancy
Nantes University Hospital
RECRUITING
Nantes
Grasse Hospital
NOT_YET_RECRUITING
Nice
Nice University Hospital and Lenval Hospital
NOT_YET_RECRUITING
Nice
Paris Necker Hospital
NOT_YET_RECRUITING
Paris
Rennes University Hospital
NOT_YET_RECRUITING
Rennes
Toulouse University Hospital
NOT_YET_RECRUITING
Toulouse
Tours University Hospital
NOT_YET_RECRUITING
Tours
Contact Information
Primary
Research and Innovation Department of Nantes UH
bp-prom-regl@chu-nantes.fr
+33253482810
Backup
Hélène AUBERT, M.D.
Helene.AUBERT@chu-nantes.fr
Time Frame
Start Date: 2025-07-23
Estimated Completion Date: 2031-07-23
Participants
Target number of participants: 819
Treatments
Experimental: Child with a congenital nevus
Other: Legal representatives
Related Therapeutic Areas
Sponsors
Leads: Nantes University Hospital

This content was sourced from clinicaltrials.gov