Medfödd naevuskohort för longitudinell utvärdering (CIRCLE)
Cirkel: Medfödd naevus -kohort för longitudinell utvärdering
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Research and Innovation Department of Nantes UH
- Telefonnummer: +33253482810
- E-post: bp-prom-regl@chu-nantes.fr
Studera Kontakt Backup
- Namn: Hélène AUBERT, M.D.
- E-post: Helene.AUBERT@chu-nantes.fr
Studieorter
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Lille, Frankrike
- Rekrytering
- CHU Lille
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Kontakt:
- Olivier PHILIP, MD
- Telefonnummer: +33 320444193
- E-post: olivier.philip@chu-lille.fr
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Huvudutredare:
- Olivier PHILIP, MD
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Alpes-Maritimes
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Nice, Alpes-Maritimes, Frankrike, 06130
- Rekrytering
- Grasse Hospital
-
Kontakt:
- Thomas HUBICHE, M.D
- Telefonnummer: +33492037777
- E-post: hubiche.t@chu-nice.fr
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Huvudutredare:
- Thomas HUBICHE, M.D
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Nice, Alpes-Maritimes, Frankrike, 06200
- Rekrytering
- Nice University Hospital and Lenval Hospital
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Kontakt:
- Christine CHIAVERINI, M.D
- Telefonnummer: +33492037777
- E-post: chiaverini.c@chu-nice.fr
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Huvudutredare:
- Christine CHIAVERINI, M.D
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Bouches-du-Rhône
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Marseille, Bouches-du-Rhône, Frankrike, 13005
- Rekrytering
- Marseille University Hospital
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Kontakt:
- Stéphanie MALLET, M.D
- Telefonnummer: +33491380000
- E-post: Stephanie.mallet@ap-hm.fr
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Huvudutredare:
- Stéphanie MALLET, M.D
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Côte-d'Or
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Dijon, Côte-d'Or, Frankrike, 21000
- Rekrytering
- Dijon University Hospital
-
Kontakt:
- Bertille BONNIAUD, M.D
- Telefonnummer: +33380293031
- E-post: bertille.bonniaud@chu-dijon.fr
-
Huvudutredare:
- 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
- Rekrytering
- La Réunion University Hospital
-
Kontakt:
- Juliette MIQUEL, M.D
- Telefonnummer: +33262359000
- E-post: Juliette.miquel@chu-reunion.fr
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Huvudutredare:
- Juliette MIQUEL, M.D
-
-
Finistère
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Brest, Finistère, Frankrike, 29200
- Rekrytering
- Brest University Hospital
-
Kontakt:
- Claire ABASQ, M.D
- Telefonnummer: +33298223315
- E-post: claire.abasq@chu-brest.fr
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Huvudutredare:
- Claire ABASQ, M.D
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Gironde
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Bordeaux, Gironde, Frankrike, 33000
- Rekrytering
- Bordeaux University Hospital
-
Kontakt:
- Dorine CANU, M.D
- Telefonnummer: +33557822828
- E-post: dorine.canu@chu-bordeaux.fr
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Huvudutredare:
- Dorine CANU, M.D
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Haute-Garonne
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Toulouse, Haute-Garonne, Frankrike, 31300
- Rekrytering
- Toulouse University Hospital
-
Kontakt:
- Maella SEVERINO-FREIRE, M.D
- Telefonnummer: +33567771408
- E-post: severino-freire.m@chu-toulouse.fr
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Huvudutredare:
- Maella SEVERINO-FREIRE, M.D
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Ille-et-Vilaine
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Rennes, Ille-et-Vilaine, Frankrike, 35000
- Rekrytering
- Rennes University Hospital
-
Kontakt:
- Catherine DROITCOURT, M.D
- Telefonnummer: +33299284368
- E-post: Catherine.droitcourt@chu-rennes.fr
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Huvudutredare:
- Catherine DROITCOURT, M.D
-
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Indre-et-Loire
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Tours, Indre-et-Loire, Frankrike
- Rekrytering
- Tours University Hospital
-
Kontakt:
- Annabel MARUANI, UH Practitioner
- Telefonnummer: +33663392409
- E-post: annabel.maruani@univ-tours.fr
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Huvudutredare:
- Annabel MARUANI, UH Practitioner
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Loire Atlantique
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Nantes, Loire Atlantique, Frankrike, 44300
- Rekrytering
- Nantes University Hospital
-
Kontakt:
- Hélène AUBERT, M.D.
- Telefonnummer: +33240083126
- E-post: Helene.AUBERT@chu-nantes.fr
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Huvudutredare:
- Hélène AUBERT, M.D.
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Maine et Loire
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Angers, Maine et Loire, Frankrike, 49100
- Rekrytering
- Angers University Hospital
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Kontakt:
- Ludovic MARTIN, UH Practitioner
- Telefonnummer: +33241353637
- E-post: LuMartin@chu-angers.fr
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Huvudutredare:
- Ludovic MARTIN, UH Practitioner
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Meurthe-et-Moselle
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Nancy, Meurthe-et-Moselle, Frankrike, 54000
- Rekrytering
- Nancy University Hospital
-
Kontakt:
- Anne-Claire BURSZTEJN, M.D
- Telefonnummer: +33383157146
- E-post: Ac.bursztejn@chru-nancy.fr
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Huvudutredare:
- Anne-Claire BURSZTEJN, M.D
-
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Nord
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Lille, Nord, Frankrike, 59000
- Rekrytering
- Saint Vincent de Paul Hospital
-
Kontakt:
- Audrey LASEK, M.D
- Telefonnummer: +33320877576
- E-post: lasek.audrey@ghicl.net
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Huvudutredare:
- Audrey LASEK, M.D
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Paris
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Paris, Paris, Frankrike, 75015
- Rekrytering
- Paris Necker Hospital
-
Kontakt:
- Olivia BOCCARA, M.D
- Telefonnummer: +33144494000
- E-post: olivia.boccara@aphp.fr
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Huvudutredare:
- Olivia BOCCARA, M.D
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Undersökning
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Barn med en medfödd 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 |
|
Övrig: Rättsrepresentanter
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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.
Tidsram: 3 years.
|
This assessment will be conducted using the ASQ-3 (Ages and Stages Questionnaires, Third Edition). |
3 years.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Förekomsten av andra neurologiska avvikelser (tidig epilepsi, etc.), screening för psykomotoriska utvecklingsförseningar.
Tidsram: 3 år
|
3 år
|
|
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Förekomsten av neurologiska avvikelser på MR (magnetisk resonansavbildning), både absolut och enligt egenskaperna hos den medfödda nevusen.
Tidsram: 3 år.
|
3 år.
|
|
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Förekomsten av tidigt melanom eller en annan tumör.
Tidsram: 3 år.
|
3 år.
|
|
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Identifiering av faktorer som påverkar den kliniska vårdvägen och deras korrelation på hälsoutfall.
Tidsram: 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).
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RC24_0532
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