Medfødt naevus kohort for langsgående evaluering (CIRCLE)
Sirkel: Medfødt Naevus -kohort for langsgående evaluering
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Research and Innovation Department of Nantes UH
- Telefonnummer: +33253482810
- E-post: bp-prom-regl@chu-nantes.fr
Studer Kontakt Backup
- Navn: Hélène AUBERT, M.D.
- E-post: Helene.AUBERT@chu-nantes.fr
Studiesteder
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Lille, Frankrike
- Rekruttering
- CHU Lille
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Ta kontakt med:
- Olivier PHILIP, MD
- Telefonnummer: +33 320444193
- E-post: olivier.philip@chu-lille.fr
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Hovedetterforsker:
- Olivier PHILIP, MD
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Alpes-Maritimes
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Nice, Alpes-Maritimes, Frankrike, 06130
- Rekruttering
- Grasse Hospital
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Ta kontakt med:
- Thomas HUBICHE, M.D
- Telefonnummer: +33492037777
- E-post: hubiche.t@chu-nice.fr
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Hovedetterforsker:
- Thomas HUBICHE, M.D
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Nice, Alpes-Maritimes, Frankrike, 06200
- Rekruttering
- Nice University Hospital and Lenval Hospital
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Ta kontakt med:
- Christine CHIAVERINI, M.D
- Telefonnummer: +33492037777
- E-post: chiaverini.c@chu-nice.fr
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Hovedetterforsker:
- Christine CHIAVERINI, M.D
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, Frankrike, 13005
- Rekruttering
- Marseille University Hospital
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Ta kontakt med:
- Stéphanie MALLET, M.D
- Telefonnummer: +33491380000
- E-post: Stephanie.mallet@ap-hm.fr
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Hovedetterforsker:
- Stéphanie MALLET, M.D
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Côte-d'Or
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Dijon, Côte-d'Or, Frankrike, 21000
- Rekruttering
- Dijon University Hospital
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Ta kontakt med:
- Bertille BONNIAUD, M.D
- Telefonnummer: +33380293031
- E-post: bertille.bonniaud@chu-dijon.fr
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Hovedetterforsker:
- Bertille BONNIAUD, M.D
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Département Et Région d'Outre-mer
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La Réunion, Département Et Région d'Outre-mer, Frankrike, 97400
- Rekruttering
- La Réunion University Hospital
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Ta kontakt med:
- Juliette MIQUEL, M.D
- Telefonnummer: +33262359000
- E-post: Juliette.miquel@chu-reunion.fr
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Hovedetterforsker:
- Juliette MIQUEL, M.D
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Finistère
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Brest, Finistère, Frankrike, 29200
- Rekruttering
- Brest University Hospital
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Ta kontakt med:
- Claire ABASQ, M.D
- Telefonnummer: +33298223315
- E-post: claire.abasq@chu-brest.fr
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Hovedetterforsker:
- Claire ABASQ, M.D
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Gironde
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Bordeaux, Gironde, Frankrike, 33000
- Rekruttering
- Bordeaux University Hospital
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Ta kontakt med:
- Dorine CANU, M.D
- Telefonnummer: +33557822828
- E-post: dorine.canu@chu-bordeaux.fr
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Hovedetterforsker:
- Dorine CANU, M.D
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Haute-Garonne
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Toulouse, Haute-Garonne, Frankrike, 31300
- Rekruttering
- Toulouse University Hospital
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Ta kontakt med:
- Maella SEVERINO-FREIRE, M.D
- Telefonnummer: +33567771408
- E-post: severino-freire.m@chu-toulouse.fr
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Hovedetterforsker:
- Maella SEVERINO-FREIRE, M.D
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Ille-et-Vilaine
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Rennes, Ille-et-Vilaine, Frankrike, 35000
- Rekruttering
- Rennes University Hospital
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Ta kontakt med:
- Catherine DROITCOURT, M.D
- Telefonnummer: +33299284368
- E-post: Catherine.droitcourt@chu-rennes.fr
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Hovedetterforsker:
- Catherine DROITCOURT, M.D
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Indre-et-Loire
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Tours, Indre-et-Loire, Frankrike
- Rekruttering
- Tours University Hospital
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Ta kontakt med:
- Annabel MARUANI, UH Practitioner
- Telefonnummer: +33663392409
- E-post: annabel.maruani@univ-tours.fr
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Hovedetterforsker:
- Annabel MARUANI, UH Practitioner
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Loire Atlantique
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Nantes, Loire Atlantique, Frankrike, 44300
- Rekruttering
- Nantes University Hospital
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Ta kontakt med:
- Hélène AUBERT, M.D.
- Telefonnummer: +33240083126
- E-post: Helene.AUBERT@chu-nantes.fr
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Hovedetterforsker:
- Hélène AUBERT, M.D.
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Maine et Loire
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Angers, Maine et Loire, Frankrike, 49100
- Rekruttering
- Angers University Hospital
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Ta kontakt med:
- Ludovic MARTIN, UH Practitioner
- Telefonnummer: +33241353637
- E-post: LuMartin@chu-angers.fr
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Hovedetterforsker:
- Ludovic MARTIN, UH Practitioner
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Meurthe-et-Moselle
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Nancy, Meurthe-et-Moselle, Frankrike, 54000
- Rekruttering
- Nancy University Hospital
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Ta kontakt med:
- Anne-Claire BURSZTEJN, M.D
- Telefonnummer: +33383157146
- E-post: Ac.bursztejn@chru-nancy.fr
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Hovedetterforsker:
- Anne-Claire BURSZTEJN, M.D
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Nord
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Lille, Nord, Frankrike, 59000
- Rekruttering
- Saint Vincent de Paul Hospital
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Ta kontakt med:
- Audrey LASEK, M.D
- Telefonnummer: +33320877576
- E-post: lasek.audrey@ghicl.net
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Hovedetterforsker:
- Audrey LASEK, M.D
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Paris
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Paris, Paris, Frankrike, 75015
- Rekruttering
- Paris Necker Hospital
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Ta kontakt med:
- Olivia BOCCARA, M.D
- Telefonnummer: +33144494000
- E-post: olivia.boccara@aphp.fr
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Hovedetterforsker:
- Olivia BOCCARA, M.D
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Barn med en medfødt nevus
|
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.) Collection of patient quality of life data |
|
Annen: Juridiske representanter
|
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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.
Tidsramme: 3 years.
|
This assessment will be conducted using the ASQ-3 (Ages and Stages Questionnaires, Third Edition). |
3 years.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Forekomsten av andre nevrologiske avvik (tidlig epilepsi, etc.), screening for psykomotoriske utviklingsforsinkelser.
Tidsramme: 3 år
|
3 år
|
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Utbredelsen av nevrologiske avvik på MR (magnetisk resonansavbildning), både absolutt og i henhold til egenskapene til den medfødte nevus.
Tidsramme: 3 år.
|
3 år.
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Forekomsten av tidlig melanom eller en annen svulst.
Tidsramme: 3 år.
|
3 år.
|
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Identifisering av faktorer som påvirker den kliniske omsorgsveien og deres sammenheng med helseutfall.
Tidsramme: 3 år.
|
3 år.
|
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The evolution of the clinical characteristics of the congenital nevus (size, color, texture, number of satellites), and associated functional signs (pruritus).
Tidsramme: 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.
|
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Description of the histopathological characteristics of the congenital nevus (if available) following excision or biopsy.
Tidsramme: 3 years.
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If an excision or biopsy is performed, it will be possible to provide the histopathological characteristics of the congenital nevus (CN). |
3 years.
|
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Description of the molecular characteristics of the congenital nevus (if available) following excision or biopsy.
Tidsramme: 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.
|
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Parental satisfaction of cares management and surgery.
Tidsramme: 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.
|
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Lesion acceptance and quality of life.
Tidsramme: 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 the patient's well-being using the Cartoon CDLQI test.
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RC24_0532
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