Endocrine; DeficiencyBIChE-1NCT06618703
Brain Irradiation for Childhood Cancer - Endocrine Monitoring During the First Years
A study testing Blood sample, urine sample, osteodensitometry in people with Endocrine; Deficiency and Hypothalamo-Pituitary Disorder, run by University Hospital, Angers at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Endocrine; Deficiency, Hypothalamo-Pituitary Disorder, Radiotherapy Side Effect
- What is being tested?
- Blood sample, urine sample, osteodensitometry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 3 sitesFrance
- Study dates
- 10 Oct 2025to Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Charlotte Demoor-Goldschmidt, Dr contact
France3 sites, 3 recruiting
- Recruiting
CHU Angers
Angers, 49033
Natacha Bouhours-Nouet, 0241353863, nabouhours-nouet@chu-angers.fr
- Recruiting
Hospices Civils de Lyon
Bron, 69500
Mélanie DAVAL-COTE, 0472118890, melanie.daval-cote@chu-lyon.fr
- Recruiting
CHU Rennes
Rennes, 35023
Tommaso DE GIORGIS, 0299267114, Tommaso.De.Giorgis@chu-rennes.fr
About this study
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)
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.
Read more
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.
- Being tested
- Blood sample, urine sample, osteodensitometry
- Keywords
- Hypothalamic-pituitary axis deficiency, cerebral radiotherapy, brain tumours, endocrine monitoring, follow-up protocol
- Medical subject headings
- Radiation Injuries, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample, urine sample, osteodensitometryRadiation
Blood sample, urine sample, osteodensitometry
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Blood sample, urine sample, osteodensitometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start10 Oct 2025
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine; DeficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention research with minimum risks and constraints
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618703
- Sponsor's protocol ID
- 49RC24_0193
- Acronym
- BIChE-1
- Status last verified
- Mar 2026
- First submitted
- 30 Jul 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06618703
- Acronym / sponsor ID
- BIChE-1 / 49RC24_0193
- Keywords
- Hypothalamic-pituitary axis deficiency, cerebral radiotherapy, brain tumours, endocrine monitoring, follow-up protocol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention research with minimum risks and constraints
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Radiation: Blood sample, urine sample, osteodensitometrySpecific 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. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample, urine sample, osteodensitometryBlood sample, urine sample, osteodensitometry | Radiation | Study Arm |
Primary outcome
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)
Time frame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy
Measurement of hormon level for : * growth hormone deficiency * gonadal insufficiency * hypothyroidism * adrenal insufficiency
9 secondary outcomes
To define risk factors for anterior pituitary insufficiency in patients who received brain radiotherapy, taking into account treatment characteristics and clinical data.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy
Hormone deficiencies on fatigue in adult patients
Time frame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy
Hormone deficiencies on cognitive disorders in adult patients
Time frame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy
Fatigue measurement in patients after the introduction of hormone replacement therapy
Time frame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
Related trials for Endocrine; Deficiency
RecruitingPhase 3
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer
Epithelial Ovarian Cancer
RecruitingPhase 3
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
Hypogonadism, Male
RecruitingObservational study
Natural History Study of Patients With Excess Androgen
Congenital Adrenal Hyperplasia (CAH), Familial Male-Limited Precocious Puberty (FMPP)
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charlotte Demoor-Goldschmidt, Dr contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample, urine sample, osteodensitometry in people with Endocrine; Deficiency and Hypothalamo-Pituitary Disorder, run by University Hospital, Angers at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Demoor-Goldschmidt, Dr (0241353565 ext. +33, Charlotte.DemoorGoldschmidt@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Follow-up of 4 years, within a maximum of 5 years post-radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.