[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"puberty-precocious\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:puberty-precocious":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,82,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"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":21,"type":22},62,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30],"Puberty, Precocious","Breast","Environmental Exposure",[32,33,34,35,36],"Early puberty","Endocrine disruptors","Girls","Breast growth","Environmental Health Measure","RECRUITING","2026-03-16",{"date":40,"type":41},"2026-03-17","ACTUAL",{"date":43,"type":41},"2023-05-15",{"date":45,"type":22},"2027-05-15",{"name":47,"class":48},"Lille Catholic University","OTHER",2,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":4,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":66,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100536364","first-observatory-of-precocious-puberty-100536364","NCT06263868","First Observatory of Precocious Puberty.","First Observatory of Precocious and Advanced Puberty in Private Healthcare.","PAPPEL","Inclusion Criteria:\n\nPrecocious puberty group (PP) :\n\n* Suspected precocious puberty (girl aged \\\u003C 8 years or boy aged \\\u003C 9 years when the first signs of development\\* appear)\n* Suspected precocious puberty (girl aged \\\u003C 8 years or boy aged \\\u003C 9 years when the first signs of development\\* appear)\n\nAdvanced puberty group (AP) :\n\n* Suspected advanced puberty (girl aged ≥ 8 and \\\u003C 10 years or boy aged ≥ 9 and \\\u003C 11 years when the first signs of development\\* appear)\n* First consultation with the investigator (pediatric endocrinologist).\n\nControl group :\n\n* Boy or girl without signs of pubertal development (Tanner 1);\n* Matched to the PP group on sex and age (+\u002F- 1 year);\n* Consultation with the same investigator over the same period (same quarter) as a patient in the PP group\n\nExclusion Criteria:\n\nAll groups\n\n* Consultation with the same investigator over the same period (same quarter) as a patient in the PP group\n* Family not speaking French, language barrier.",true,"ALL","11 Years",{"count":62,"type":22},3360,"OBSERVATIONAL","The age of puberty has fluctuated throughout history. Recent data shows an increase in the age of onset of puberty signs, in the United States but also in Europe. A recent Public Health France study published in 2018 reports an increase in the incidence of precocious puberty with geographical heterogeneity. The consequences of these appearances include the early onset of menarche, short adult height and the psychological impact.\n\nDue to a lack of studies and additional data, the reasons for this development are difficult to understand. Among current hypotheses, the entanglement with the evolution of our environment is at the forefront: the action of environmental endocrine disruptors and nutritional factors could play a role in the process of early appearance of pubertal signs.\n\nThe establishment of a national observatory for early and advanced puberty in collaboration with pediatric endocrinologists (on the front line) would allow a reliable and precise field approach, capable of supplementing epidemiological data, which are currently insufficient.\n\nThe investigators hypothesize that the establishment of an observatory of pubertal advances (early puberty and advanced puberty) in private medicine is possible, with inclusion of at least 75% of eligible patients, and collection of at least 80% of data.",[28],[67,68,69,70,71],"Early\u002Fprecocious puberty","advanced puberty","national observatory","private medicine","feasibility","2026-01-15",{"date":74,"type":41},"2026-01-16",{"date":76,"type":41},"2024-06-26",{"date":78,"type":22},"2028-06-26",{"name":80,"class":48},"Hospices Civils de Lyon",25,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":58,"sex":59,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100430403","the-3rd-copenhagen-puberty-study-100430403","NCT04884620","The 3rd COPENHAGEN Puberty Study","The COPENHAGEN School Study. Normal Pubertal Development in Youth 2021 and Long-term Disease and Death Risk After Extremely Early Puberty","Inclusion Criteria:\n\n* Healthy children and adolescents\n\nExclusion Criteria:\n\n* In case of acute disease, cancer, cancer therapy, or chronic disease (History of malignant disease, chemotherapy or radiation, cystic fibrosis, juvenile rheumatoid arthritis, systemic lupus erythematosus, sickle cell disease, thalassemia, chronic renal disease or known numerical chromosome aberration)\n* Non-Caucasian","5 Years","19 Years",{"count":92,"type":22},3000,"The COPENHAGEN School Study is a combined cross-sectional and longitudinal study of healthy Danish school children. This study will by clinical examinations and withdrawal of blood samples investigate whether age of pubertal onset is continuing to decline in Denmark over the past 15 years. Furthermore, we will investigate the mechanism driving earlier onset of puberty and the long term health risks of extremely early puberty using Danish registry data",[95,28],"Puberty","2024-01-09",{"date":98,"type":41},"2024-01-10",{"date":100,"type":41},"2023-01-01",{"date":102,"type":22},"2056-12-31",{"name":104,"class":48},"Rigshospitalet, Denmark",1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":59,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":118,"studyType":63,"phases":4,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100512864","danish-precocious-puberty-study---dapp-study-a-national-cohort-study-on-incidence-and-etiologies-for-precocious-puberty-100512864","NCT05957991","Danish Precocious Puberty Study - DAPP Study A National Cohort Study on Incidence and Etiologies for Precocious Puberty","Danish Precocious Puberty Study (DAPP Study) A National Cohort Study on Incidence and Etiologies for Precocious Puberty","DAPP","Inclusion Criteria:\n\n• All children (\\> 4 years of age) referred to one of the seventeen collaborating pediatric departments with one of the following diagnosis (ICD10)\n\n* DE301\n* DE228A\n* DE308A\n* DE270B\n* DE308\n* DE309\n* DZ003\n\nExclusion Criteria:\n\n* If the investigating doctor at the local hospital observes unexpected psychological\u002Fphysical reactions, or a participant is found to be unsuitable (cf. inclusion criteria) or regrets agreeing to participate, this person can at any given time be excluded.","3 Years","10 Years",{"count":117,"type":22},1500,"2 Years","There is an urgent need to obtain more knowledge about the influence of weight and metabolism on the timing and progression of puberty. The age of pubertal onset has been constantly declining during the last decades and extremely early maturation may have yet unseen consequences for the psychosocial development of the child as well as detrimental long-term health consequences. Studies have shown that girls with early-onset puberty are more likely than their peers to enter sexual relationships at a younger age, to experience more psychological distress, and to engage in risk-taking behaviors. In addition, early maturation may have long-term health consequences since earlier menarche is associated with an increased risk of all-cause mortality and cardiovascular disease later in life in large epidemiological studies. The exact aetiology for the earlier onset of puberty in the general population remains to be elucidated, and the cause is probably to be found in a complex interplay between genetic, epigenetic, environmental and metabolic factors. However, world-wide there is a concerning increasing prevalence of overweight in childhood and early puberty is one of many consequences of this. Environmental factors such as endocrine disrupting chemicals have been suggested to play a role for both obesity and precocious puberty either directly or through epigenetic moderation. The current study of a Danish National cohort will explore the incidence and aetiology of precocious puberty for better treatment and prevention. Furthermore, a placebo-controlled randomized controlled trial may give a novel mechanistic insight of the interplay between insulin sensitivity and sex steroids. To our knowledge this study is the first of its kind and may lead to novel alternative treatment strategy for overweight girls with early puberty that may have beneficial effects on long-term morbidity and mortality.",[28],[95],"NOT_YET_RECRUITING","2023-07-14",{"date":125,"type":41},"2023-07-24",{"date":127,"type":22},"2023-09-01",{"date":129,"type":22},"2030-09",{"name":131,"class":48},"Copenhagen University Hospital at Herlev",5]