NCT06618703Recruiting
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)
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 230 (estimated)
- First submitted
- 30 Jul 2024
- Start date
- 10 Oct 2025
- Primary completion date
- Oct 2030
- Lead sponsor
- University Hospital, Angers
- Diseases
- Childhood cancers
- NCT number
- NCT06618703
What you commit to
- Study type: Interventional
- Planned participants: 230
- From 10 Oct 2025 to the primary completion date, Oct 2030
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Patients who have relapsed or developed a second cancer with a post-treatment delay of \< 1 year
Other
- Patient in palliative situation
- Refusal of child or parents
Who the study is looking for
- 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
Age in the registry: 4 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Angers Coordinator of this site? Confirm its status | Angers | France | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| CHU Rennes Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.