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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 4 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endocrine; Deficiency
• Hypothalamo-Pituitary Disorder
• Radiotherapy Side Effect

Interventions

Type	Name	Description
RADIATION	Blood sample, urine sample, osteodensitometry	Blood sample, urine sample, osteodensitometry

Timeline

• Start date: 2025-10-10
• Primary completion: 2030-10-01
• Completion: 2030-10-01
• First posted: 2024-10-01
• Last updated: 2026-04-06

Locations

3 sites across 1 country: France