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

NCT06618703 | Not Yet Recruiting

• 1 other identifier: 49RC24_0193
• Study Type: interventional
• Target: 230
• Locations: 0 countries
• Sites: N/A

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

Keywords

Hypothalamic-pituitary axis deficiency; cerebral radiotherapy; brain tumours; endocrine monitoring; follow-up protocol

Outcome Measures

Primary Outcomes (1)

• 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)

  Measurement of hormon level for : * growth hormone deficiency * gonadal insufficiency * hypothyroidism * adrenal insufficiency

  Follow-up of 4 years, within a maximum of 5 years post-radiotherapy

Secondary Outcomes (9)

• To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.

  Follow-up of 4 years, within a maximum of 5 years post-radiotherapy

• To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.

  Follow-up of 4 years, within a maximum of 5 years post-radiotherapy

• To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.

  Follow-up of 4 years, within a maximum of 5 years post-radiotherapy

• To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.

  Follow-up of 4 years, within a maximum of 5 years post-radiotherapy

• To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.

  Follow-up of 4 years, within a maximum of 5 years post-radiotherapy

Study Arms (1)

Study Arm

EXPERIMENTAL

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.

Radiation: Blood sample, urine sample, osteodensitometry

Interventions

Blood sample, urine sample, osteodensitometry RADIATION

Blood sample, urine sample, osteodensitometry

Study Arm

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

MeSH Terms

Conditions

Radiation Injuries; Brain Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Wounds and Injuries; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Charlotte Demoor-Goldschmidt, Dr

CONTACT

0241353565; Charlotte.DemoorGoldschmidt@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Intervention research with minimum risks and constraints

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: October 1, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: February 25, 2025

Record last verified: 2025-02