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Clinical Trials in France / NCT06618703
Recruiting Not applicable

Brain Irradiation for Childhood Cancer - Endocrine Monitoring During the First Years

NCT06618703 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Angers
Phase
Not applicable
Started
2025-10-10
Last updated
2026-04-06

Condition(s) studied

Endocrine; DeficiencyHypothalamo-Pituitary DisorderRadiotherapy Side Effect

Investigational drug(s) / intervention(s)

Blood sample, urine sample, osteodensitometry

Blood sample, urine sample, osteodensitometry: Blood sample, urine sample, osteodensitometry

Study 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

Sex
ALL
Min age
4 Years
Max age
18 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Endocrine toxicities assessment after radiotherapy involving all or part of the brain in children, adolescents and young adults treated for cancer before the age of 16 (≤15 years) — Follow-up of 4 years, within a maximum of 5 years post-radiotherapy
    Measurement of hormon level for : * growth hormone deficiency * gonadal insufficiency * hypothyroidism * adrenal insufficiency

Trial sites (3)

FacilityCityRegionStatus
CHU Angers Angers France Recruiting
Hospices Civils de Lyon Bron France Recruiting
CHU Rennes Rennes France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06618703 on ClinicalTrials.gov ↗ ← All trials in France