CongenItal Naevus Cohort for Longitudinal Evaluation (CIRCLE)

March 5, 2026 updated by: Nantes University Hospital

CIRCLE : CongenItal Naevus Cohort for Longitudinal Evaluation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

819

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lille, France
        • Not yet recruiting
        • Chu Lille
        • Contact:
        • Principal Investigator:
          • Olivier PHILIP, MD
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06130
        • Not yet recruiting
        • Grasse Hospital
        • Contact:
        • Principal Investigator:
          • Thomas HUBICHE, M.D
      • Nice, Alpes-Maritimes, France, 06200
        • Not yet recruiting
        • Nice University Hospital and Lenval Hospital
        • Contact:
        • Principal Investigator:
          • Christine CHIAVERINI, M.D
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13005
        • Not yet recruiting
        • Marseille University hospital
        • Contact:
        • Principal Investigator:
          • Stéphanie MALLET, M.D
    • Côte-d'Or
      • Dijon, Côte-d'Or, France, 21000
        • Not yet recruiting
        • Dijon University Hospital
        • Contact:
        • Principal Investigator:
          • Bertille BONNIAUD, M.D
    • Département Et Région d'Outre-mer
      • La Réunion, Département Et Région d'Outre-mer, France, 97400
        • Not yet recruiting
        • La Réunion University Hospital
        • Contact:
        • Principal Investigator:
          • Juliette MIQUEL, M.D
    • Finistère
      • Brest, Finistère, France, 29200
        • Not yet recruiting
        • Brest University Hospital
        • Contact:
        • Principal Investigator:
          • Claire ABASQ, M.D
    • Gironde
      • Bordeaux, Gironde, France, 33000
        • Not yet recruiting
        • Bordeaux University Hospital
        • Contact:
        • Principal Investigator:
          • Dorine CANU, M.D
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31300
        • Not yet recruiting
        • Toulouse University Hospital
        • Contact:
        • Principal Investigator:
          • Maella SEVERINO-FREIRE, M.D
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35000
        • Not yet recruiting
        • Rennes University Hospital
        • Contact:
        • Principal Investigator:
          • Catherine DROITCOURT, M.D
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France
        • Not yet recruiting
        • Tours University Hospital
        • Contact:
        • Principal Investigator:
          • Annabel MARUANI, UH Practitioner
    • Loire Atlantique
      • Nantes, Loire Atlantique, France, 44300
        • Recruiting
        • Nantes University Hospital
        • Contact:
        • Principal Investigator:
          • Hélène AUBERT, M.D.
    • Maine et Loire
      • Angers, Maine et Loire, France, 49100
        • Not yet recruiting
        • Angers University Hospital
        • Contact:
        • Principal Investigator:
          • Ludovic MARTIN, UH Practitioner
    • Meurthe-et-Moselle
      • Nancy, Meurthe-et-Moselle, France, 54000
        • Not yet recruiting
        • Nancy University Hospital
        • Contact:
        • Principal Investigator:
          • Anne-Claire BURSZTEJN, M.D
    • Nord
      • Lille, Nord, France, 59000
        • Not yet recruiting
        • Saint Vincent de Paul Hospital
        • Contact:
        • Principal Investigator:
          • Audrey LASEK, M.D
    • Paris
      • Paris, Paris, France, 75015
        • Not yet recruiting
        • Paris Necker Hospital
        • Contact:
        • Principal Investigator:
          • Olivia BOCCARA, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Child with a congenital nevus
Other: Neurodevelopmental assessment
This assessment will be conducted using the ASQ-3 test. (ASQ-3 stands for Ages and Stages Questionnaires, Third Edition, which is a common screening tool for evaluating developmental progress in young children.)
Other: Patient quality of life assessment
Collection of patient quality of life data
Other: Legal representatives
Other: Meeting with the parents
This meeting will evaluate the parents' acceptance of the lesion and their quality of life using the MARKS test (Measure of Acceptance of Skin Marks). The results will provide insights into how the parents perceive the lesion and how it impacts their daily lives.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the prevalence of neurodevelopmental abnormalities in infants and young children with medium to giant congenital nevus, and according to nevus characteristics (size, number), at the age of 3 years.
Time Frame: 3 years.
This assessment will be conducted using the ASQ-3 (Ages and Stages Questionnaires, Third Edition).
3 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The occurrence of other neurological abnormalities (early epilepsy, etc.), screening for psychomotor developmental delays.
Time Frame: 3 years
3 years
The prevalence of neurological abnormalities on MRI (Magnetic Resonance Imaging), both absolutely and according to the characteristics of the congenital nevus.
Time Frame: 3 years.
3 years.
The occurrence of early melanoma or another tumor.
Time Frame: 3 years.
3 years.
The evolution of the clinical characteristics of the congenital nevus (size, color, texture, number of satellites), and associated functional signs (pruritus).
Time Frame: 3 years.
According to the Krengel classification 1 (size, projected adult size, number of satellites) and assessment of color, roughness, hair growth, pruritus/eczematization, and proliferative nodules.
3 years.
Description of the histopathological characteristics of the congenital nevus (if available) following excision or biopsy.
Time Frame: 3 years.
If an excision or biopsy is performed, it will be possible to provide the histopathological characteristics of the congenital nevus (CN).
3 years.
Description of the molecular characteristics of the congenital nevus (if available) following excision or biopsy.
Time Frame: 3 years.
If an excision or biopsy is performed, it will be possible to provide the molecular characteristics of the congenital nevus (CN).
3 years.
Parental satisfaction of cares management and surgery.
Time Frame: 3 years.
Parental satisfaction with the management and surgery, if performed, and evaluation of the patient's satisfaction with the intervention using a Visual Analog Scale (VAS).
3 years.
Lesion acceptance and quality of life.
Time Frame: 3 years.
The parents' acceptance of the lesion and their quality of life will be evaluated using the MARKS test (Measure of Acceptance of Skin Marks). The results will provide insights into how the parents perceive the lesion and how it impacts their daily lives.
3 years.
Identification of factors influencing the clinical care pathway and their correlation on health outcomes.
Time Frame: 3 years.
3 years.
Identification of the patient's well-being using the Cartoon CDLQI test.
Time Frame: 3 years.
The Cartoon Children's Dermatology Life Quality Index (Cartoon CDLQI) is a version of the Children's Dermatology Life Quality Index (CDLQI) designed to make assessing the quality of life in children with skin diseases more engaging and accessible for younger children. (Scale from 1 to 4 ; with 4 being the worst outcome ( "a lot" ) and 1 being the best ("not at all").
3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2025

Primary Completion (Estimated)

July 23, 2031

Study Completion (Estimated)

July 23, 2031

Study Registration Dates

First Submitted

January 29, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

February 14, 2025

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC24_0532

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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