RecruitingNot Applicable

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

France230 participantsStarted 2025-10-10

Plain-language summary

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.

Who can participate

Age range4 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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)

Timeframe: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy

Trial details

NCT IDNCT06618703

SponsorUniversity Hospital, Angers

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2030-10

Contact for this trial

Charlotte Demoor-Goldschmidt, Dr

0241353565 Charlotte.DemoorGoldschmidt@chu-angers.fr