NaeviCIRCLENCT06828822
CongenItal Naevus Cohort for Longitudinal Evaluation
A study testing Neurodevelopmental assessment, Meeting with the parents and Patient quality of life assessment in people with Naevi and Neurodevelopmental Disorder, run by Nantes University Hospital at 16 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years to 24 months
- Conditions the study is for
- Naevi, Neurodevelopmental Disorder, Congenital Nevus
- What is being tested?
- Neurodevelopmental assessment, Meeting with the parents and Patient quality of life assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 819 participants
- Where
- 16 sitesFrance
- Study dates
- 23 Jul 2025to 23 Jul 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hélène AUBERT, M.D. contact
16 sites in 1 country
France16 sites, 16 recruiting
- Recruiting
Angers University Hospital
Angers, Maine et Loire, 49100
Ludovic MARTIN, UH Practitioner, +33241353637, LuMartin@chu-angers.fr
Ludovic MARTIN, UH Practitioner
- Recruiting
Bordeaux University Hospital
Bordeaux, Gironde, 33000
Dorine CANU, M.D, +33557822828, dorine.canu@chu-bordeaux.fr
Dorine CANU, M.D
- Recruiting
Brest University Hospital
Brest, Finistère, 29200
Claire ABASQ, M.D, +33298223315, claire.abasq@chu-brest.fr
Claire ABASQ, M.D
- Recruiting
Dijon University Hospital
Dijon, Côte-d'Or, 21000
Bertille BONNIAUD, M.D, +33380293031, bertille.bonniaud@chu-dijon.fr
Bertille BONNIAUD, M.D
- Recruiting
La Réunion University Hospital
La Réunion, Département Et Région d'Outre-mer, 97400
Juliette MIQUEL, M.D, +33262359000, Juliette.miquel@chu-reunion.fr
Juliette MIQUEL, M.D
- Recruiting
Saint Vincent de Paul Hospital
Lille, Nord, 59000
Audrey LASEK, M.D, +33320877576, lasek.audrey@ghicl.net
Audrey LASEK, M.D
- Recruiting
CHU Lille
Lille
Olivier PHILIP, MD, +33 320444193, olivier.philip@chu-lille.fr
Olivier PHILIP, MD
- Recruiting
Marseille University Hospital
Marseille, Bouches-du-Rhône, 13005
Stéphanie MALLET, M.D, +33491380000, Stephanie.mallet@ap-hm.fr
Stéphanie MALLET, M.D
- Recruiting
Nancy University Hospital
Nancy, Meurthe-et-Moselle, 54000
Anne-Claire BURSZTEJN, M.D, +33383157146, Ac.bursztejn@chru-nancy.fr
Anne-Claire BURSZTEJN, M.D
- Recruiting
Nantes University Hospital
Nantes, Loire Atlantique, 44300
Hélène AUBERT, M.D., +33240083126, Helene.AUBERT@chu-nantes.fr
Hélène AUBERT, M.D.
- Recruiting
Grasse Hospital
Nice, Alpes-Maritimes, 06130
Thomas HUBICHE, M.D, +33492037777, hubiche.t@chu-nice.fr
Thomas HUBICHE, M.D
- Recruiting
Nice University Hospital and Lenval Hospital
Nice, Alpes-Maritimes, 06200
Christine CHIAVERINI, M.D, +33492037777, chiaverini.c@chu-nice.fr
Christine CHIAVERINI, M.D
- Recruiting
Paris Necker Hospital
Paris, Paris, 75015
Olivia BOCCARA, M.D, +33144494000, olivia.boccara@aphp.fr
Olivia BOCCARA, M.D
- Recruiting
Rennes University Hospital
Rennes, Ille-et-Vilaine, 35000
Catherine DROITCOURT, M.D, +33299284368, Catherine.droitcourt@chu-rennes.fr
Catherine DROITCOURT, M.D
- Recruiting
Toulouse University Hospital
Toulouse, Haute-Garonne, 31300
Maella SEVERINO-FREIRE, M.D, +33567771408, severino-freire.m@chu-toulouse.fr
Maella SEVERINO-FREIRE, M.D
- Recruiting
Tours University Hospital
Tours, Indre-et-Loire
Annabel MARUANI, UH Practitioner, +33663392409, annabel.maruani@univ-tours.fr
Annabel MARUANI, UH Practitioner
About this study
Official title: 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:
Read more
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.
- Conditions
- Naevi, Neurodevelopmental Disorder, Congenital Nevus
- Being tested
- Neurodevelopmental assessment, Meeting with the parents, Patient quality of life assessment
- Keywords
- Congenital Nevus, Neurodevelopmental Disorder
- Medical subject headings
- Nevus, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodevelopmental assessmentOther
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.)
Meeting with the parentsOther
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.
Patient quality of life assessmentOther
Collection of patient quality of life data
| Study group | Role | What they receive |
|---|---|---|
| Child with a congenital nevus | Experimental | Not described Receives: Other: Neurodevelopmental assessment; Other: Patient quality of life assessment |
| Legal representatives | Other | Not described Receives: Other: Meeting with the parents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
This assessment will be conducted using the ASQ-3 (Ages and Stages Questionnaires, Third Edition).
Measured: 3 years.
Secondary outcomes (10)
The occurrence of other neurological abnormalities (early epilepsy, etc.), screening for psychomotor developmental delays.
Measured: 3 years
The prevalence of neurological abnormalities on MRI (Magnetic Resonance Imaging), both absolutely and according to the characteristics of the congenital nevus.
Measured: 3 years.
The occurrence of early melanoma or another tumor.
Measured: 3 years.
The evolution of the clinical characteristics of the congenital nevus (size, color, texture, number of satellites), and associated functional signs (pruritus).
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.
Measured: 3 years.
Description of the histopathological characteristics of the congenital nevus (if available) following excision or biopsy.
If an excision or biopsy is performed, it will be possible to provide the histopathological characteristics of the congenital nevus (CN).
Measured: 3 years.
Description of the molecular characteristics of the congenital nevus (if available) following excision or biopsy.
If an excision or biopsy is performed, it will be possible to provide the molecular characteristics of the congenital nevus (CN).
Measured: 3 years.
Parental satisfaction of cares management and surgery.
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).
Measured: 3 years.
Lesion acceptance and quality of life.
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.
Measured: 3 years.
Identification of factors influencing the clinical care pathway and their correlation on health outcomes.
Measured: 3 years.
Identification of the patient's well-being using the Cartoon CDLQI test.
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").
Measured: 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start23 Jul 2025
- Primary completion23 Jul 2031 (estimated)
- Study completion23 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NaeviStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 819 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828822
- Sponsor's protocol ID
- RC24_0532
- Acronym
- CIRCLE
- Status last verified
- Sep 2026
- First submitted
- 29 Jan 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided