Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-01-02 @ 9:44 AM
Study NCT ID:
NCT06618703
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-25
First Post:
2024-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Irradiation for Childhood Cancer - Endocrine Monitoring During the First Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Intervention research with minimum risks and constraints'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 230}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2030-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2024-07-30', 'studyFirstSubmitQcDate': '2024-09-27', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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)', 'timeFrame': 'Follow-up of 4 years, within a maximum of 5 years post-radiotherapy', 'description': 'Measurement of hormon level for :\n\n* growth hormone deficiency\n* gonadal insufficiency\n* hypothyroidism\n* adrenal insufficiency'}], 'secondaryOutcomes': [{'measure': 'To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.', 'timeFrame': 'Follow-up of 4 years, within a maximum of 5 years post-radiotherapy', 'description': '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).'}, {'measure': 'To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.', 'timeFrame': 'Follow-up of 4 years, within a maximum of 5 years post-radiotherapy', 'description': 'Maximum dose (Dmax): The maximum dose received by a small portion of tissue in these critical organs.'}, {'measure': 'To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.', 'timeFrame': 'Follow-up of 4 years, within a maximum of 5 years post-radiotherapy', 'description': 'Volume irradiated (%): This parameter measures the proportion of the organ exposed to radiotherapy.'}, {'measure': 'To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.', 'timeFrame': 'Follow-up of 4 years, within a maximum of 5 years post-radiotherapy', 'description': 'Average dose (Dmean) and D50%: The average and median dose received by the whole organ.'}, {'measure': 'To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.', 'timeFrame': 'Follow-up of 4 years, within a maximum of 5 years post-radiotherapy', 'description': 'Minimum dose (Dmin): minimum dose received by the organ.'}, {'measure': 'To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.', 'timeFrame': 'Follow-up of 4 years, within a maximum of 5 years post-radiotherapy', 'description': '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.'}, {'measure': 'Hormone deficiencies on fatigue in adult patients', 'timeFrame': 'Follow-up of 4 years, within a maximum of 5 years post-radiotherapy', 'description': 'Measurement by a questionnaire assessing fatigue (PedsQL Multidimensional Fatigue scale) composed of 18 items comprising 3 dimensions.\n\n5-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'}, {'measure': 'Hormone deficiencies on cognitive disorders in adult patients', 'timeFrame': 'Follow-up of 4 years, within a maximum of 5 years post-radiotherapy', 'description': 'Measurement by a questionnaire assessing fatigue (PedsQL Multidimensional Fatigue scale) composed of 18 items comprising 3 dimensions.\n\n5-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'}, {'measure': 'Fatigue measurement in patients after the introduction of hormone replacement therapy', 'timeFrame': 'Follow-up of 4 years, within a maximum of 5 years post-radiotherapy', 'description': 'Measurement by a questionnaire assessing fatigue (PedsQL Multidimensional Fatigue scale) composed of 18 items comprising 3 dimensions.\n\n5-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'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypothalamic-pituitary axis deficiency', 'cerebral radiotherapy', 'brain tumours', 'endocrine monitoring', 'follow-up protocol'], 'conditions': ['Endocrine; Deficiency', 'Hypothalamo-Pituitary Disorder', 'Radiotherapy Side Effect']}, 'descriptionModule': {'briefSummary': 'BICHE- 1: Brain Irradiation for Childhood cancer - Endocrine monitoring during the first five years is a study of endocrine monitoring after cerebral radiotherapy.\n\nThe 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.\n\nThe 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".\n\nIn 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged 4 years or more (≥4) and less than 18 years (\\<18) at inclusion\n* Treated with radiotherapy to part or all of the brain for cancer or hematological malignancy before age 16 (≤15)\n* Post-radiotherapy time less than or equal to 5 years (≤5)\n* In remission of this pathology at the end of oncological treatments, or, with stable residual disease without treatment for 2 years or more (≥2)\n* Signature of informed consent from parents or legal guardian\n* Patient affiliated to the social security system or beneficiary of such a system\n\nExclusion Criteria:\n\n* Patients who have relapsed or developed a second cancer with a post-treatment delay of \\< 1 year\n* Patient in palliative situation\n* Brain irradiation with dosimetric data showing sparing of the hypothalamic-pituitary axis (Dmax hypothalamic-pituitary axis \\< 15 Gy)\n* Patient with a known hypothalamic-pituitary axis endocrine deficit prior to radiotherapy\n* Refusal of child or parents'}, 'identificationModule': {'nctId': 'NCT06618703', 'acronym': 'BIChE-1', 'briefTitle': 'Brain Irradiation for Childhood Cancer - Endocrine Monitoring During the First Years', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Endocrine Follow-up After Cerebral Radiotherapy Performed Before Age 16 (Direct Cerebral Field or Following Facial, Cervical or High Ear, Nose, and Throat Radiotherapy)', 'orgStudyIdInfo': {'id': '49RC24_0193'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Arm', 'description': 'Specific interventions:\n\nFor 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.\n\nA 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.\n\nFor 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.', 'interventionNames': ['Radiation: Blood sample, urine sample, osteodensitometry']}], 'interventions': [{'name': 'Blood sample, urine sample, osteodensitometry', 'type': 'RADIATION', 'description': 'Blood sample, urine sample, osteodensitometry', 'armGroupLabels': ['Study Arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Charlotte Demoor-Goldschmidt, Dr', 'role': 'CONTACT', 'email': 'Charlotte.DemoorGoldschmidt@chu-angers.fr', 'phone': '0241353565', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}