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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample, urine sample, osteodensitometry | Radiation | Blood sample, urine sample, osteodensitometry |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 :
| Follow-up of 4 years, within a maximum of 5 years post-radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data. | Dose absorbed (Gy) by sensitive organs: This parameter corresponds to the total amount of radiation absorbed by the hypothalamus and pituitary gland, two key structures of the endocrine axis. A cumulative dose above certain thresholds is associated with a higher risk of long-term endocrine dysfunction - possibly after adjustment for the biological equivalent dose (which also takes fractionation into account). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlotte Demoor-Goldschmidt, Dr | Contact | 0241353565 | +33 | Charlotte.DemoorGoldschmidt@chu-angers.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Recruiting | Angers | 49033 | France |
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| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Intervention research with minimum risks and constraints
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| 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. | Maximum dose (Dmax): The maximum dose received by a small portion of tissue in these critical organs. | 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. | Volume irradiated (%): This parameter measures the proportion of the organ exposed to radiotherapy. | 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. | Average dose (Dmean) and D50%: The average and median dose received by the whole organ. | 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. | Minimum dose (Dmin): minimum dose received by the organ. | 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. | Dose-volume histogram (DVH): The DVH analysis enables you to visualize the dose distribution over the entire organ, and to identify any thresholds other than those listed above. | Follow-up of 4 years, within a maximum of 5 years post-radiotherapy |
| Hormone deficiencies on fatigue in adult patients | Measurement by a questionnaire assessing fatigue (PedsQL Multidimensional Fatigue scale) composed of 18 items comprising 3 dimensions. 5-point Likert scale from: 0 (Never) to 4 (Almost always) 3-point Likert scale from: 0 (Not at all), 2 (Sometimes) and 4 (A lot) for the Child Report for Young Children (ages 5-7) then Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0 | Follow-up of 4 years, within a maximum of 5 years post-radiotherapy |
| Hormone deficiencies on cognitive disorders in adult patients | Measurement by a questionnaire assessing fatigue (PedsQL Multidimensional Fatigue scale) composed of 18 items comprising 3 dimensions. 5-point Likert scale from: 0 (Never) to 4 (Almost always) 3-point Likert scale from: 0 (Not at all), 2 (Sometimes) and 4 (A lot) for the Child Report for Young Children (ages 5-7) then Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0 | Follow-up of 4 years, within a maximum of 5 years post-radiotherapy |
| Fatigue measurement in patients after the introduction of hormone replacement therapy | Measurement by a questionnaire assessing fatigue (PedsQL Multidimensional Fatigue scale) composed of 18 items comprising 3 dimensions. 5-point Likert scale from: 0 (Never) to 4 (Almost always) 3-point Likert scale from: 0 (Not at all), 2 (Sometimes) and 4 (A lot) for the Child Report for Young Children (ages 5-7) then Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0 | Follow-up of 4 years, within a maximum of 5 years post-radiotherapy |
| Hospices Civils de Lyon | Recruiting | Bron | 69500 | France |
|
| CHU Rennes | Recruiting | Rennes | 35023 | France |
|
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |