Actively Recruiting
CIRCLE: Congenital Nevus Cohort for Longitudinal Evaluation
Led by Nantes University Hospital · Updated on 2026-03-09
819
Participants Needed
16
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying congenital nevus (CN), a pigmented skin lesion present at birth that grows as the child grows. CN varies in size from small to giant and is linked to genetic mutations mainly in NRAS/BRAF genes. Larger CNs may lead to neurological problems such as neuro-meningeal melanosis and developmental delays, as well as an increased risk of melanoma. The study also looks at the social and emotional impact on children and their families, aiming to improve monitoring and treatment guidelines. The study involves children under 2 years old with medium to giant CN. It includes neurodevelopmental assessments using the ASQ-3 screening tool, meetings with parents to assess acceptance and quality of life via the MARKS test, and evaluations of patient quality of life. The study is non-randomized and observational in nature, focusing on monitoring and understanding CN characteristics and related risks. Participants will be followed for 3 years, during which the study will measure neurodevelopmental abnormalities, neurological issues such as epilepsy, MRI findings, melanoma occurrence, and changes in CN features. It will also assess parental satisfaction with care, lesion acceptance, and patient well-being through questionnaires. This long-term follow-up aims to gather detailed information to guide future CN management and improve outcomes for affected children.
CONDITIONS
Brief Title
CongenItal Naevus Cohort for Longitudinal Evaluation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants with medium to giant congenital nevus are monitored to assess neurodevelopmental progress, neurological abnormalities, and clinical characteristics of the nevus over time.
Periodic visits over 3 years
Trial Site Locations
Total: 16 locations
1
Grasse Hospital
Nice, Alpes-Maritimes, France, 06130
Not Yet Recruiting
2
Nice University Hospital and Lenval Hospital
Nice, Alpes-Maritimes, France, 06200
Not Yet Recruiting
3
Marseille University Hospital
Marseille, Bouches-du-Rhône, France, 13005
Not Yet Recruiting
4
Dijon University Hospital
Dijon, Côte-d'Or, France, 21000
Not Yet Recruiting
5
La Réunion University Hospital
La Réunion, Département Et Région d'Outre-mer, France, 97400
Not Yet Recruiting
6
Brest University Hospital
Brest, Finistère, France, 29200
Not Yet Recruiting
7
Bordeaux University Hospital
Bordeaux, Gironde, France, 33000
Not Yet Recruiting
8
Toulouse University Hospital
Toulouse, Haute-Garonne, France, 31300
Not Yet Recruiting
9
Rennes University Hospital
Rennes, Ille-et-Vilaine, France, 35000
Not Yet Recruiting
10
Tours University Hospital
Tours, Indre-et-Loire, France
Not Yet Recruiting
11
Nantes University Hospital
Nantes, Loire Atlantique, France, 44300
Actively Recruiting
12
Angers University Hospital
Angers, Maine et Loire, France, 49100
Not Yet Recruiting
13
Nancy University Hospital
Nancy, Meurthe-et-Moselle, France, 54000
Not Yet Recruiting
14
Saint Vincent de Paul Hospital
Lille, Nord, France, 59000
Not Yet Recruiting
15
Paris Necker Hospital
Paris, Paris, France, 75015
Not Yet Recruiting
16
CHU Lille
Lille, France
Not Yet Recruiting
Research Team
R
Research and Innovation Department of Nantes UH
H
Hélène AUBERT, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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