[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"endocrine-deficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:endocrine-deficiency":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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},"100563633","brain-irradiation-for-childhood-cancer---endocrine-monitoring-during-the-first-years-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":21,"type":22},230,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30],"Endocrine; Deficiency","Hypothalamo-Pituitary Disorder","Radiotherapy Side Effect",[32,33,34,35,36],"Hypothalamic-pituitary axis deficiency","cerebral radiotherapy","brain tumours","endocrine monitoring","follow-up protocol","RECRUITING","2026-03-31",{"date":40,"type":41},"2026-04-06","ACTUAL",{"date":43,"type":41},"2025-10-10",{"date":45,"type":22},"2030-10",{"name":47,"class":48},"University Hospital, Angers","OTHER_GOV",3]