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

NCT ID: NCT06618703

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2030-10-31

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.

Conditions

Endocrine; Deficiency; Hypothalamo-Pituitary Disorder; Radiotherapy Side Effect

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Study Arm

Specific interventions:

For all patients, an insulin level is added every 2 years. For patients under 8 years of age, additional elements such as testosterone (in male patients), Luteinizing hormone , Follicle-stimulating hormone, estradiol (in female patients), inhibin B +/- Anti-Müllerian hormone are measured during the usual blood test.

A urinary check-up is systematically added for all patients, whereas it is usually only prescribed after certain chemotherapies (platinum salts, ifosfamide), nephrectomy, radiotherapy to the flanks as part of routine care. This check-up will be carried out at 2 and 4 years post-radiotherapy.

For patients aged 12 and over, a second bone densitometry is performed at the end of follow-up, even if the first is normal. In routine care, international guidelines recommend this first bone densitometry, and the second is usually performed only if the first was abnormal.

Group Type: EXPERIMENTAL

Blood sample, urine sample, osteodensitometry

Intervention Type: RADIATION

Blood sample, urine sample, osteodensitometry

Interventions

Blood sample, urine sample, osteodensitometry

Blood sample, urine sample, osteodensitometry

Intervention Type: RADIATION

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Charlotte Demoor-Goldschmidt, Dr

Role: CONTACT

Charlotte.DemoorGoldschmidt@chu-angers.fr

0241353565 ext. +33

Other Identifiers

49RC24_0193

Identifier Type: -

Identifier Source: org_study_id