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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CIRCLE : CongenItal Naevus Cohort for Longitudinal Evaluation
- ClinicalTrials.gov ID
- NCT06828822
- Acronym / sponsor ID
- CIRCLE / RC24_0532
- Conditions
- Naevi, Neurodevelopmental Disorder, Congenital Nevus
- Keywords
- Congenital Nevus, Neurodevelopmental Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 819 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- 23 Jul 2031 (estimated)
- Study completion
- 23 Jul 2031 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Child with a congenital nevus | Experimental | Other: Neurodevelopmental assessment, Other: Patient quality of life assessment |
| Legal representatives | Other | Other: Meeting with the parents |
Who may qualify
- Ages
- 0 years to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurodevelopmental assessmentThis 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 | Child with a congenital nevus |
| Meeting with the parentsThis 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. | Other | Legal representatives |
| Patient quality of life assessmentCollection of patient quality of life data | Other | Child with a congenital nevus |
Primary outcome
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).
10 secondary outcomes
The occurrence of other neurological abnormalities (early epilepsy, etc.), screening for psychomotor developmental delays.
Time frame: 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.
The occurrence of early melanoma or another tumor.
Time frame: 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.
Description of the histopathological characteristics of the congenital nevus (if available) following excision or biopsy.
Time frame: 3 years.
Description of the molecular characteristics of the congenital nevus (if available) following excision or biopsy.
Time frame: 3 years.
Parental satisfaction of cares management and surgery.
Time frame: 3 years.
Lesion acceptance and quality of life.
Time frame: 3 years.
Identification of factors influencing the clinical care pathway and their correlation on health outcomes.
Time frame: 3 years.
Identification of the patient's well-being using the Cartoon CDLQI test.
Time frame: 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Naevi
Not yet recruitingPhase 2
Mirdametinib to Reduce the Size of Large/Giant Congenital Melanocytic Nevi in Children, Adolescents and Young Adults
LGCMN, Large and Giant Congenital Melanocytic Nevi
RecruitingObservational study
Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma
Melanoma, Dysplastic Nevus Syndrome
Not yet recruiting
Development of an Aid to Melanoma Detection Using Artificial Intelligence Algorithms Based on Images From the VECTRA 3D System.
Naevi
RecruitingPhase 3
Using an Artificial Intelligence (AI) Tool for Melanoma Diagnosis
Malignant Melanoma of Skin, Other and Unspecified Malignant Neoplasm of Skin
RecruitingPhase 3
The Cancer of the Pancreas Screening-5 CAPS5)Study
Pancreas Cancer, Peutz-Jeghers Syndrome (PJS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hélène AUBERT, M.D. contact
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research and Innovation Department of Nantes UH (+33253482810, bp-prom-regl@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.