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Brain Irradiation for Childhood Cancer - Endocrine Monitoring During the First Years

RecruitingNAAges 4 Years - 18 YearsAllUniversity Hospital, Angers
NCT06618703 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

BICHE- 1: Brain Irradiation for Childhood cancer - Endocrine monitoring during the first five years is a study of endocrine monitoring after cerebral radiotherapy. The 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. The 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". In this population, the investigators will conduct a descriptive and ex

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patient aged 4 years or more (≥4) and less than 18 years (\<18) at inclusion * Treated with radiotherapy to part or all of the brain for cancer or hematological malignancy before age 16 (≤15) * Post-radiotherapy time less than or equal to 5 years (≤5) * In remission of this pathology at the end of oncological treatments, or, with stable residual disease without treatment for 2 years or more (≥2) * Signature of informed consent from parents or legal guardian * Patient affiliated to the social security system or beneficiary of such a system Exclusion Criteria: * Patients who have relapsed or developed a second cancer with a post-treatment delay of \< 1 year * Patient in palliative situation * Brain irradiation with dosimetric data showing sparing of the hypothalamic-pituitary axis (Dmax hypothalamic-pituitary axis \< 15 Gy) * Patient with a known hypothalamic-pituitary axis endocrine deficit prior to radiotherapy * Refusal of child or parents
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What it tests

  • Blood sample, urine sample, osteodensitometry
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Where

3 sites
CHU Angers
Angers, France
Hospices Civils de Lyon
Bron, France
CHU Rennes
Rennes, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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