Brain Irradiation for Childhood Cancer - Endocrine Monitoring During the First Years
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-18
SponsorUniversity Hospital, Angers
About this trial
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
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Blood sample, urine sample, osteodensitometry
Treatment groups
230 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov