NCT06618703 Brain Irradiation for Childhood Cancer - Endocrine Monitoring During the First Years
| NCT ID | NCT06618703 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Angers |
| Condition | Endocrine; Deficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 230 participants |
| Start Date | 2025-10-10 |
| Primary Completion | 2030-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 230 participants in total. It began in 2025-10-10 with a primary completion date of 2030-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06618703 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 18 Years, studying Endocrine; Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06618703 currently recruiting?
Yes, NCT06618703 is actively recruiting participants. Contact the research team at Charlotte.DemoorGoldschmidt@chu-angers.fr for enrollment information.
Where is the NCT06618703 trial being conducted?
This trial is being conducted at Angers, France, Bron, France, Rennes, France.
Who is sponsoring the NCT06618703 clinical trial?
NCT06618703 is sponsored by University Hospital, Angers. The trial plans to enroll 230 participants.