Actively Recruiting
Brain Irradiation for Childhood Cancer - Endocrine Monitoring During the First Years
Led by University Hospital, Angers · Updated on 2026-04-06
230
Participants Needed
3
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Brain Irradiation for Childhood Cancer - Endocrine Monitoring During the First Years
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 4 years or older and less than 18 years at inclusion
- Treated with radiotherapy to part or all of the brain for cancer or blood cancer before age 16
- Time since radiotherapy is 5 years or less
- In remission or has stable residual disease without treatment for 2 years or more
- Informed consent signed by parents or legal guardian
- Patient covered by social security or equivalent
You will not qualify if you...
- Patient has relapsed or developed a second cancer with less than 1 year since treatment
- Patient is in a palliative care situation
- Radiotherapy spared the hypothalamic-pituitary axis with maximum dose less than 15 Gy
- Known hypothalamic-pituitary endocrine deficiency before radiotherapy
- Patient or parents refuse participation
AI-Screening
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Trial Site Locations
Total: 3 locations
1
CHU Angers
Angers, France, 49033
Actively Recruiting
2
Hospices Civils de Lyon
Bron, France, 69500
Actively Recruiting
3
CHU Rennes
Rennes, France, 35023
Actively Recruiting
Research Team
C
Charlotte Demoor-Goldschmidt, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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