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

Recruiting now · Not applicable

Conditions studied: Endocrine; Deficiency, Hypothalamo-Pituitary Disorder, Radiotherapy Side Effect

In brief

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.

Key facts

Study ID

NCT06618703

Run by

University Hospital, Angers

People needed

230

Starts

2025-10-10

Expected to finish

2030-10-01

Last updated by the study team

2026-04-06

Who can join

Age: 4 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CHU Angers — Angers, France (enrolling)
• Hospices Civils de Lyon — Bron, France (enrolling)
• CHU Rennes — Rennes, France (enrolling)

Full record on ClinicalTrials.gov

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