NCT06828822 CongenItal Naevus Cohort for Longitudinal Evaluation
| NCT ID | NCT06828822 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nantes University Hospital |
| Condition | Naevi |
| Study Type | INTERVENTIONAL |
| Enrollment | 819 participants |
| Start Date | 2025-07-23 |
| Primary Completion | 2031-07-23 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 819 participants in total. It began in 2025-07-23 with a primary completion date of 2031-07-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06828822 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 24 Months, studying Naevi. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06828822 currently recruiting?
Yes, NCT06828822 is actively recruiting participants. Contact the research team at bp-prom-regl@chu-nantes.fr for enrollment information.
Where is the NCT06828822 trial being conducted?
This trial is being conducted at Nice, France, Nice, France, Marseille, France, Dijon, France and 11 additional locations.
Who is sponsoring the NCT06828822 clinical trial?
NCT06828822 is sponsored by Nantes University Hospital. The trial plans to enroll 819 participants.