Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618703
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Brain Irradiation for Childhood Cancer - Endocrine Monitoring During the First Years
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Endocrine Follow-up After Cerebral Radiotherapy Performed Before Age 16 Direct Cerebral Field or Following Facial Cervical or High Ear Nose and Throat Radiotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIChE-1
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 annuallyThe 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
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 annuallyThe 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None