[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563633":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":27,"responsibleParty":74,"collaborators":19,"id":76,"slug":19,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":19,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":30,"whyStopped":19,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"University Hospital, Angers","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Study Arm","EXPERIMENTAL","Specific interventions:\n\nFor all patients, an insulin level is added every 2 years. For patients under 8 years of age, additional elements such as testosterone (in male patients), Luteinizing hormone , Follicle-stimulating hormone, estradiol (in female patients), inhibin B +\u002F- Anti-Müllerian hormone are measured during the usual blood test.\n\nA urinary check-up is systematically added for all patients, whereas it is usually only prescribed after certain chemotherapies (platinum salts, ifosfamide), nephrectomy, radiotherapy to the flanks as part of routine care. This check-up will be carried out at 2 and 4 years post-radiotherapy.\n\nFor patients aged 12 and over, a second bone densitometry is performed at the end of follow-up, even if the first is normal. In routine care, international guidelines recommend this first bone densitometry, and the second is usually performed only if the first was abnormal.",[13],"Radiation: Blood sample, urine sample, osteodensitometry",[15],{"type":16,"name":17,"description":17,"armGroupLabels":18,"otherNames":19},"RADIATION","Blood sample, urine sample, osteodensitometry",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},"Charlotte Demoor-Goldschmidt, Dr","CONTACT","0241353565","+33","Charlotte.DemoorGoldschmidt@chu-angers.fr",[28,46,60],{"facility":29,"status":30,"city":31,"state":19,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"CHU Angers","RECRUITING","Angers","49033","France","FR",{"type":36,"coordinates":37},"Point",[38,39],-0.55202,47.47156,{"lat":39,"lon":38},[42],{"name":43,"role":23,"phone":44,"phoneExt":19,"email":45},"Natacha Bouhours-Nouet","0241353863","nabouhours-nouet@chu-angers.fr",{"facility":47,"status":30,"city":48,"state":19,"zip":49,"country":33,"countryCode":34,"cosmosGeoPoint":50,"geoPoint":54,"contacts":55},"Hospices Civils de Lyon","Bron","69500",{"type":36,"coordinates":51},[52,53],4.91303,45.73865,{"lat":53,"lon":52},[56],{"name":57,"role":23,"phone":58,"phoneExt":19,"email":59},"Mélanie DAVAL-COTE","0472118890","melanie.daval-cote@chu-lyon.fr",{"facility":61,"status":30,"city":62,"state":19,"zip":63,"country":33,"countryCode":34,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"CHU Rennes","Rennes","35023",{"type":36,"coordinates":65},[66,67],-1.67431,48.11109,{"lat":67,"lon":66},[70],{"name":71,"role":23,"phone":72,"phoneExt":19,"email":73},"Tommaso DE GIORGIS","0299267114","Tommaso.De.Giorgis@chu-rennes.fr",{"type":75,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100563633",false,"NCT06618703","Brain Irradiation for Childhood Cancer - Endocrine Monitoring During the First Years","Endocrine Follow-up After Cerebral Radiotherapy Performed Before Age 16 (Direct Cerebral Field or Following Facial, Cervical or High Ear, Nose, and Throat Radiotherapy)","BIChE-1","Inclusion Criteria:\n\n* Patient aged 4 years or more (≥4) and less than 18 years (\\\u003C18) at inclusion\n* Treated with radiotherapy to part or all of the brain for cancer or hematological malignancy before age 16 (≤15)\n* Post-radiotherapy time less than or equal to 5 years (≤5)\n* In remission of this pathology at the end of oncological treatments, or, with stable residual disease without treatment for 2 years or more (≥2)\n* Signature of informed consent from parents or legal guardian\n* Patient affiliated to the social security system or beneficiary of such a system\n\nExclusion Criteria:\n\n* Patients who have relapsed or developed a second cancer with a post-treatment delay of \\\u003C 1 year\n* Patient in palliative situation\n* Brain irradiation with dosimetric data showing sparing of the hypothalamic-pituitary axis (Dmax hypothalamic-pituitary axis \\\u003C 15 Gy)\n* Patient with a known hypothalamic-pituitary axis endocrine deficit prior to radiotherapy\n* Refusal of child or parents","ALL","4 Years","18 Years",{"count":87,"type":88},230,"ESTIMATED","INTERVENTIONAL",[91],"NA","BICHE- 1: Brain Irradiation for Childhood cancer - Endocrine monitoring during the first five years is a study of endocrine monitoring after cerebral radiotherapy.\n\nThe study concerns patients in remission at the end of oncological treatment aged between 4 and 18 years at the time of inclusion and who have had radiotherapy before the age of 16, irradiating all or part of the brain, with a delay between the end of radiotherapy and inclusion of less than 5 years. Patients will be included during a routine visit to the paediatric endocrinologist.\n\nThe protocol for the Biche 1 study has been designed and discussed in a multidisciplinary and multicentre manner, based on data from the literature and the French reference document (September 2021) \"National protocol for diagnosis and care - congenital pituitary deficiency\".\n\nIn this population, the investigators will conduct a descriptive and exploratory study to establish recommendations for medium-term follow-up; to improve screening for endocrine deficiencies affecting the hypothalamic-pituitary axis in order to improve patients' quality of life and state of health; and to better define dose-volume constraints on the axis.\n\nThe study will also focus on better detection and characterisation of chronic fatigue as a potential sequela of pituitary deficiencies, in particular by means of a questionnaire assessing fatigue (PedsQL Multidimensional Fatigue scale) which will also be systematically administered and completed annually.The expected sample size is 100-150 patients treated for a brain tumour and 60-80 patients treated for another tumour but with an irradiation field covering all or part of the brain.",[94,95,96],"Endocrine; Deficiency","Hypothalamo-Pituitary Disorder","Radiotherapy Side Effect",[98,99,100,101,102],"Hypothalamic-pituitary axis deficiency","cerebral radiotherapy","brain tumours","endocrine monitoring","follow-up protocol","2026-03-31",{"date":105,"type":106},"2026-04-06","ACTUAL",{"date":108,"type":106},"2025-10-10",{"date":110,"type":88},"2030-10",{"name":5,"class":6},3]