Hormone check-ups during the first five years after childhood brain radiation
Endocrine Follow-up After Cerebral Radiotherapy Performed Before Age 16 (Direct Cerebral Field or Following Facial, Cervical or High Ear, Nose, and Throat Radiotherapy)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 4 Years to 18 Years |
| Sex | All |
| Sponsor | University Hospital, Angers Government |
| Locations | 3 sites (Angers and 2 other locations) |
| Trial ID | NCT06618703 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Angers and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.