[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522499":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":78,"collaborators":18,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":18,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":102,"overallStatus":49,"whyStopped":18,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Lille Catholic University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"6 to 8 years old girls, presenting with a breast flare-up","EXPERIMENTAL","Girls aged 6 to 8 years old with breast flare (isolated or not) and scheduled for pediatric day hospital stay",[13],"Other: Environmental health measures",{"label":15,"type":16,"description":17,"interventionNames":18},"6 to 8 years old girls controls","NO_INTERVENTION","Girls aged 6 to 8 years old controls, scheduled for pediatric day hospital stay, or an office consultation, or an MRI in radiology",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Environmental health measures","MRI will be used to confirm the presence of breast buds, to measure the size of the ovaries and uterus, as well as the fraction of fat mass (abdominal, subcutaneous, liver and bone marrow). The bood and urine tests will allow to measure different biological and metabolic parameters. The presence of endocrine disruptors will be determined in the hair. The bone age x ray will be estimate the maturity of the child's skeletal system. Photographs of the teeth will also be taken to be studied by pediatric odontology researchers on the on molar and incisor hypomineralization, known as MIH.",[9],[25,26,27,28,29,30],"Magnetic Resonance Imaging (MRI)","Blood tests","Determination of endocrine disruptors in hair","Urine tests","Bone age x ray","Tooth photography (MIH)",[32],{"name":33,"affiliation":34,"role":35},"Patricia RANNAUD-BARTAIRE, PhD","Hôpital Saint-Vincent de Paul","PRINCIPAL_INVESTIGATOR",[37,43],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Marie-Paule LEBITASY","CONTACT","03.20.22.52.69","+33","lebitasy.marie-paule@ghicl.net",{"name":44,"role":39,"phone":40,"phoneExt":41,"email":45},"Elodie MOUTAILLER","moutailler.elodie@ghicl.net",[47,66],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Cabinet BLM","RECRUITING","Lambersart","Hauts-de-France","59130","France","FR",{"type":56,"coordinates":57},"Point",[58,59],3.03333,50.65,{"lat":59,"lon":58},[62,64],{"name":33,"role":39,"phone":18,"phoneExt":18,"email":63},"bartaire.patricia@ghicl.net",{"name":65,"role":35,"phone":18,"phoneExt":18,"email":18},"Patricia RANNAUD-BARTAIRE",{"facility":67,"status":49,"city":68,"state":51,"zip":69,"country":53,"countryCode":54,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Saint Vincent hospital","Lille","59000",{"type":56,"coordinates":71},[72,73],3.05512,50.63391,{"lat":73,"lon":72},[76,77],{"name":33,"role":39,"phone":18,"phoneExt":18,"email":63},{"name":33,"role":35,"phone":18,"phoneExt":18,"email":18},{"type":79,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100522499","early-breast-growth-in-girls-aged-6-to-8-years-in-the-current-environmental-context-100522499",false,"NCT06083415","Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context","Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context: Clinical and Biological Parameters, Level of Impregnation With Endocrine Disruptors and Evaluation of the Impact of Environmental Health Measures","PENELOPE","For patients:\n\nInclusion Criteria:\n\n* Girls aged 6 to 8 years\n* Presenting a breast development (isolated or not)\n* Undergoing scheduled pediatric day hospital care (HDJ)\n* Who agree to participate in the study\n* Whose parents agree to their child's participation in the study\n* French speaking\n* Whose parents speak French\n* Affiliated to social security\n\nExclusion Criteria:\n\n* Organic brain causes of precocious puberty: History of neurocerebral disease (malformations, developmental abnormalities)\n* Organic causes of precocious puberty: Mac Cune Albright syndrome, ovarian cyst or tumor and adrenal hyperplasia\n* History of chemotherapy or radiation therapy\n* Presenting with a communication disorder\n* Pregnancy\n* Persons under protective measures\n* Persons deprived of liberty for judicial or administrative reasons\n\nFor controls:\n\nInclusion Criteria:\n\n* Girls aged 6 to 8\n* Tanner stage 1: Absence of breasts and hairiness\n* Coming for routine consultation in the pediatric HDJ at Saint-Vincent-de-Paul hospital, or at the BLM practice in Lambersart, or to radiology for an MRI for another medical other medical reason\n* Agree to participate in the study\n* Whose parents agree to their child's participation in the the study\n* French-speaking\n* Whose parents speak French\n* Affiliated with social security\n\nExclusion Criteria:\n\n* Signs of puberty (Tanner stages 2, 3, 4 and 5 for breast development) breast development)\n* Previous chemotherapy or radiotherapy\n* Presenting a communication disorder\n* Pregnant women\n* Persons under protective supervision\n* Persons deprived of their liberty for judicial or administrative reasons","FEMALE","6 Years","8 Years",{"count":92,"type":93},62,"ESTIMATED","INTERVENTIONAL",[96],"NA","Various studies show an increase in the number of cases of early puberty in girls with breast development with a variable clinical presentation and evolution. This increasing phenomenon concerns girls between 6 and 8 years old. In a large number of cases, from 70 to 95% depending on the series, no medical cause is found and environmental factors are suspected to be involved.\n\nDescriptive studies of these patients are scarce and not always provide an overview of all the parameters in line with the concept of the exposome.\n\nThe PENELOPE clinical trial will allow to analyze a large number of parameters, including the adipose tissue, its metabolism, the endocrine disruptors, and the epigenetic modifications, and to study the impact of environmental health measures in the evolution of these parameters.\n\nThe data from the analyses of the endocrine disruptors of the patients will be explored in parallel in experimental models (amphibians, murine, cellular) in order to test potential mechanistic hypotheses.",[99,100,101],"Puberty, Precocious","Breast","Environmental Exposure",[103,104,105,106,107],"Early puberty","Endocrine disruptors","Girls","Breast growth","Environmental Health Measure","2026-03-16",{"date":110,"type":111},"2026-03-17","ACTUAL",{"date":113,"type":111},"2023-05-15",{"date":115,"type":93},"2027-05-15",{"name":5,"class":6},2]