Actively Recruiting

Phase Not Applicable
Age: 4Years - 18Years
All Genders
NCT06618703

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

Led by University Hospital, Angers · Updated on 2026-04-06

230

Participants Needed

3

Research Sites

259 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 4Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged 4 years or older and less than 18 years at inclusion
  • Treated with radiotherapy to part or all of the brain for cancer or blood cancer before age 16
  • Time since radiotherapy is 5 years or less
  • In remission or has stable residual disease without treatment for 2 years or more
  • Informed consent signed by parents or legal guardian
  • Patient covered by social security or equivalent
Not Eligible

You will not qualify if you...

  • Patient has relapsed or developed a second cancer with less than 1 year since treatment
  • Patient is in a palliative care situation
  • Radiotherapy spared the hypothalamic-pituitary axis with maximum dose less than 15 Gy
  • Known hypothalamic-pituitary endocrine deficiency before radiotherapy
  • Patient or parents refuse participation

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

CHU Angers

Angers, France, 49033

Actively Recruiting

2

Hospices Civils de Lyon

Bron, France, 69500

Actively Recruiting

3

CHU Rennes

Rennes, France, 35023

Actively Recruiting

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Research Team

C

Charlotte Demoor-Goldschmidt, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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