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

Официальное название

Endocrine Follow-up After Cerebral Radiotherapy Performed Before Age 16 (Direct Cerebral Field or Following Facial, Cervical or High Ear, Nose, and Throat Radiotherapy)

Обзор

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 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. The 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.

Вмешательства

• Лучевая терапия Blood sample, urine sample, osteodensitometry
  Blood sample, urine sample, osteodensitometry

Первичные конечные точки

• Endocrine toxicities assessment after radiotherapy involving all or part of the brain in children, adolescents and young adults treated for cancer before the age of 16 (≤15 years) [Срок оценки: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy]

Вторичные конечные точки (9)

• To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data. [Срок оценки: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy]
• To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data. [Срок оценки: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy]
• To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data. [Срок оценки: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy]
• To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data. [Срок оценки: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy]
• To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data. [Срок оценки: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy]
• To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data. [Срок оценки: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy]
• Hormone deficiencies on fatigue in adult patients [Срок оценки: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy]
• Hormone deficiencies on cognitive disorders in adult patients [Срок оценки: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy]
• Fatigue measurement in patients after the introduction of hormone replacement therapy [Срок оценки: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 3 центра

• CHU Angers — Angers
• Hospices Civils de Lyon — Bron
• CHU Rennes — Rennes

Идентификаторы

NCT: NCT06618703 · 49RC24_0193

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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