Hormone check-ups during the first five years after childhood brain radiation
Official title: Endocrine Follow-up After Cerebral Radiotherapy Performed Before Age 16 (Direct Cerebral Field or Following Facial, Cervical or High Ear, Nose, and Throat Radiotherapy)
Run by University Hospital, Angers · NCT06618703 · Data updated 2026-11-12
This program will test regular hormone checks for children and teens (ages 4–17) who had brain radiotherapy before age 16 to spot endocrine problems during the first five years after treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 4 Years to 18 Years |
| Sex | All |
| Enrollment | 230 (estimated) |
| Sponsor | University Hospital, Angers Government |
| Locations | 3 sites (Angers and 2 other locations) |
| Status | Recruiting |
| Started | October 10, 2025 |
| Main results expected | October 2030 |
| Study ends | October 2030 |
| Registry record updated | April 6, 2026 |
| Trial ID | NCT06618703 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 4–17 who are in remission or have stable disease, received part or whole brain radiotherapy before age 16, and are within five years of completing radiotherapy are ideal candidates.
✕Probably not a fit
Children with known hypothalamic-pituitary deficits before radiotherapy, those whose radiation spared the hypothalamic-pituitary axis (Dmax < 15 Gy), patients in palliative care, or those with a recent relapse are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
BICHE-1 enrolls children and adolescents in remission who received part or whole brain radiotherapy before age 16 and are within five years of treatment. Participants will undergo scheduled endocrine screening including blood and urine tests and bone density (osteodensitometry) at participating pediatric endocrinology centers. The protocol is descriptive and exploratory, developed by a multidisciplinary, multicenter team and aligned with the French national guidance for pituitary deficiency. Results will be used to produce standardized medium-term follow-up recommendations and improve early detection of hypothalamic-pituitary dysfunction after cranial irradiation.
Why it matters
Potential benefit: If successful, earlier detection of radiation-related hormone problems could allow timely treatment to protect growth, puberty and bone and metabolic health.
How similar studies have gone: Previous observational studies have repeatedly documented endocrine problems after childhood cranial radiotherapy and guidelines already recommend monitoring, but this coordinated multicenter protocol to standardize early follow-up is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
CHU Angers
Angers, France Recruiting -
Hospices Civils de Lyon
Bron, France Recruiting -
CHU Rennes
Rennes, France Recruiting
Study contacts
- Study coordinator: Charlotte Demoor-Goldschmidt, Dr
- Email: Charlotte.DemoorGoldschmidt@chu-angers.fr
- Phone: 0241353565
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.