[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579786":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":32,"locations":41,"responsibleParty":289,"collaborators":11,"id":291,"slug":292,"hasResults":293,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":297,"eligibilityCriteria":298,"healthyVolunteers":293,"sex":299,"minAge":300,"maxAge":301,"enrollmentInfo":302,"targetDuration":11,"studyType":305,"phases":306,"briefSummary":308,"conditions":309,"keywords":313,"overallStatus":202,"whyStopped":11,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":323},{"fullName":5,"class":6},"Nantes University Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Child with a congenital nevus","EXPERIMENTAL",null,[13,14],"Other: Neurodevelopmental assessment","Other: Patient quality of life assessment",{"label":16,"type":6,"description":11,"interventionNames":17},"Legal representatives",[18],"Other: Meeting with the parents",[20,24,28],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"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.)",[9],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"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.",[16],{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"Patient quality of life assessment","Collection of patient quality of life data",[9],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":11,"email":37},"Research and Innovation Department of Nantes UH","CONTACT","+33253482810","bp-prom-regl@chu-nantes.fr",{"name":39,"role":35,"phone":11,"phoneExt":11,"email":40},"Hélène AUBERT, M.D.","Helene.AUBERT@chu-nantes.fr",[42,63,74,90,106,122,138,154,170,186,201,215,231,247,263,278],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Grasse Hospital","NOT_YET_RECRUITING","Nice","Alpes-Maritimes","06130","France","FR",{"type":51,"coordinates":52},"Point",[53,54],7.26608,43.70313,{"lat":54,"lon":53},[57,61],{"name":58,"role":35,"phone":59,"phoneExt":11,"email":60},"Thomas HUBICHE, M.D","+33492037777","hubiche.t@chu-nice.fr",{"name":58,"role":62,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"facility":64,"status":44,"city":45,"state":46,"zip":65,"country":48,"countryCode":49,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},"Nice University Hospital and Lenval Hospital","06200",{"type":51,"coordinates":67},[53,54],{"lat":54,"lon":53},[70,73],{"name":71,"role":35,"phone":59,"phoneExt":11,"email":72},"Christine CHIAVERINI, M.D","chiaverini.c@chu-nice.fr",{"name":71,"role":62,"phone":11,"phoneExt":11,"email":11},{"facility":75,"status":44,"city":76,"state":77,"zip":78,"country":48,"countryCode":49,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Marseille University Hospital","Marseille","Bouches-du-Rhône","13005",{"type":51,"coordinates":80},[81,82],5.38107,43.29695,{"lat":82,"lon":81},[85,89],{"name":86,"role":35,"phone":87,"phoneExt":11,"email":88},"Stéphanie MALLET, M.D","+33491380000","Stephanie.mallet@ap-hm.fr",{"name":86,"role":62,"phone":11,"phoneExt":11,"email":11},{"facility":91,"status":44,"city":92,"state":93,"zip":94,"country":48,"countryCode":49,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Dijon University Hospital","Dijon","Côte-d'Or","21000",{"type":51,"coordinates":96},[97,98],5.01391,47.31344,{"lat":98,"lon":97},[101,105],{"name":102,"role":35,"phone":103,"phoneExt":11,"email":104},"Bertille BONNIAUD, M.D","+33380293031","bertille.bonniaud@chu-dijon.fr",{"name":102,"role":62,"phone":11,"phoneExt":11,"email":11},{"facility":107,"status":44,"city":108,"state":109,"zip":110,"country":48,"countryCode":49,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"La Réunion University Hospital","La Réunion","Département Et Région d'Outre-mer","97400",{"type":51,"coordinates":112},[113,114],0.11776,44.29707,{"lat":114,"lon":113},[117,121],{"name":118,"role":35,"phone":119,"phoneExt":11,"email":120},"Juliette MIQUEL, M.D","+33262359000","Juliette.miquel@chu-reunion.fr",{"name":118,"role":62,"phone":11,"phoneExt":11,"email":11},{"facility":123,"status":44,"city":124,"state":125,"zip":126,"country":48,"countryCode":49,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Brest University Hospital","Brest","Finistère","29200",{"type":51,"coordinates":128},[129,130],-4.48628,48.39029,{"lat":130,"lon":129},[133,137],{"name":134,"role":35,"phone":135,"phoneExt":11,"email":136},"Claire ABASQ, M.D","+33298223315","claire.abasq@chu-brest.fr",{"name":134,"role":62,"phone":11,"phoneExt":11,"email":11},{"facility":139,"status":44,"city":140,"state":141,"zip":142,"country":48,"countryCode":49,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Bordeaux University Hospital","Bordeaux","Gironde","33000",{"type":51,"coordinates":144},[145,146],-0.58046,44.84124,{"lat":146,"lon":145},[149,153],{"name":150,"role":35,"phone":151,"phoneExt":11,"email":152},"Dorine CANU, M.D","+33557822828","dorine.canu@chu-bordeaux.fr",{"name":150,"role":62,"phone":11,"phoneExt":11,"email":11},{"facility":155,"status":44,"city":156,"state":157,"zip":158,"country":48,"countryCode":49,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Toulouse University Hospital","Toulouse","Haute-Garonne","31300",{"type":51,"coordinates":160},[161,162],1.44367,43.60426,{"lat":162,"lon":161},[165,169],{"name":166,"role":35,"phone":167,"phoneExt":11,"email":168},"Maella SEVERINO-FREIRE, M.D","+33567771408","severino-freire.m@chu-toulouse.fr",{"name":166,"role":62,"phone":11,"phoneExt":11,"email":11},{"facility":171,"status":44,"city":172,"state":173,"zip":174,"country":48,"countryCode":49,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Rennes University Hospital","Rennes","Ille-et-Vilaine","35000",{"type":51,"coordinates":176},[177,178],-1.67431,48.11109,{"lat":178,"lon":177},[181,185],{"name":182,"role":35,"phone":183,"phoneExt":11,"email":184},"Catherine DROITCOURT, M.D","+33299284368","Catherine.droitcourt@chu-rennes.fr",{"name":182,"role":62,"phone":11,"phoneExt":11,"email":11},{"facility":187,"status":44,"city":188,"state":189,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"Tours University Hospital","Tours","Indre-et-Loire",{"type":51,"coordinates":191},[192,193],0.70398,47.39484,{"lat":193,"lon":192},[196,200],{"name":197,"role":35,"phone":198,"phoneExt":11,"email":199},"Annabel MARUANI, UH Practitioner","+33663392409","annabel.maruani@univ-tours.fr",{"name":197,"role":62,"phone":11,"phoneExt":11,"email":11},{"facility":5,"status":202,"city":203,"state":204,"zip":205,"country":48,"countryCode":49,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"RECRUITING","Nantes","Loire Atlantique","44300",{"type":51,"coordinates":207},[208,209],-1.55336,47.21725,{"lat":209,"lon":208},[212,214],{"name":39,"role":35,"phone":213,"phoneExt":11,"email":40},"+33240083126",{"name":39,"role":62,"phone":11,"phoneExt":11,"email":11},{"facility":216,"status":44,"city":217,"state":218,"zip":219,"country":48,"countryCode":49,"cosmosGeoPoint":220,"geoPoint":224,"contacts":225},"Angers University Hospital","Angers","Maine et Loire","49100",{"type":51,"coordinates":221},[222,223],-0.55202,47.47156,{"lat":223,"lon":222},[226,230],{"name":227,"role":35,"phone":228,"phoneExt":11,"email":229},"Ludovic MARTIN, UH Practitioner","+33241353637","LuMartin@chu-angers.fr",{"name":227,"role":62,"phone":11,"phoneExt":11,"email":11},{"facility":232,"status":44,"city":233,"state":234,"zip":235,"country":48,"countryCode":49,"cosmosGeoPoint":236,"geoPoint":240,"contacts":241},"Nancy University Hospital","Nancy","Meurthe-et-Moselle","54000",{"type":51,"coordinates":237},[238,239],6.18496,48.68439,{"lat":239,"lon":238},[242,246],{"name":243,"role":35,"phone":244,"phoneExt":11,"email":245},"Anne-Claire BURSZTEJN, M.D","+33383157146","Ac.bursztejn@chru-nancy.fr",{"name":243,"role":62,"phone":11,"phoneExt":11,"email":11},{"facility":248,"status":44,"city":249,"state":250,"zip":251,"country":48,"countryCode":49,"cosmosGeoPoint":252,"geoPoint":256,"contacts":257},"Saint Vincent de Paul Hospital","Lille","Nord","59000",{"type":51,"coordinates":253},[254,255],3.05512,50.63391,{"lat":255,"lon":254},[258,262],{"name":259,"role":35,"phone":260,"phoneExt":11,"email":261},"Audrey LASEK, M.D","+33320877576","lasek.audrey@ghicl.net",{"name":259,"role":62,"phone":11,"phoneExt":11,"email":11},{"facility":264,"status":44,"city":265,"state":265,"zip":266,"country":48,"countryCode":49,"cosmosGeoPoint":267,"geoPoint":271,"contacts":272},"Paris Necker Hospital","Paris","75015",{"type":51,"coordinates":268},[269,270],2.3488,48.85341,{"lat":270,"lon":269},[273,277],{"name":274,"role":35,"phone":275,"phoneExt":11,"email":276},"Olivia BOCCARA, M.D","+33144494000","olivia.boccara@aphp.fr",{"name":274,"role":62,"phone":11,"phoneExt":11,"email":11},{"facility":279,"status":44,"city":249,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":280,"geoPoint":282,"contacts":283},"CHU Lille",{"type":51,"coordinates":281},[254,255],{"lat":255,"lon":254},[284,288],{"name":285,"role":35,"phone":286,"phoneExt":11,"email":287},"Olivier PHILIP, MD","+33 320444193","olivier.philip@chu-lille.fr",{"name":285,"role":62,"phone":11,"phoneExt":11,"email":11},{"type":290,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100579786","congenital-naevus-cohort-for-longitudinal-evaluation-100579786",false,"NCT06828822","CongenItal Naevus Cohort for Longitudinal Evaluation","CIRCLE : CongenItal Naevus Cohort for Longitudinal Evaluation","CIRCLE","Inclusion Criteria:\n\n* Patient under 2 years old.\n* Patient with a medium, large, or giant congenital nevus (CN) according to the Krengel classification, either single or multiple.\n* Patient affiliated with social security.\n* Patient whose legal representatives consent to their child's participation in the project.\n\nExclusion Criteria:\n\n* Patient with light brown spots or pigmented lesions not classified as nevi.\n* Patient for whom It is impossible to establish annual follow-up.\n* Patient whose parents do not speak French.","ALL","0 Years","24 Months",{"count":303,"type":304},819,"ESTIMATED","INTERVENTIONAL",[307],"NA","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\u002FBRAF genes.\n\nA large CN can lead to several clinical issues, including:\n\nRisk 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.\n\nRisk 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.\n\nPsycho-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.\n\nManagement 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.\n\nUltimately, 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.",[310,311,312],"Naevi","Neurodevelopmental Disorder","Congenital Nevus",[312,311],"2026-03-05",{"date":316,"type":317},"2026-03-09","ACTUAL",{"date":319,"type":317},"2025-07-23",{"date":321,"type":304},"2031-07-23",{"name":5,"class":6},16]