Childhood Brain TumorsNCT07457255
Late Endocrine and Metabolic Consequences After Childhood Brain Tumor Treatment
A study testing Endocrine and Metabolic Late Effects Assessment in people with Childhood Brain Tumors and Endocrine Disorders, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
This interventional study evaluates the late endocrine and metabolic consequences of treatment of primary brain tumors in childhood. Childhood brain tumor survivors are at increased risk of developing long-term complications such as hormonal deficiencies, obesity, impaired growth, dyslipidemia, and other metabolic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Childhood Brain Tumors, Endocrine Disorders
- What is being tested?
- Endocrine and Metabolic Late Effects Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jan 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- History of primary brain tumor diagnosed and treated in childhood
- Completed treatment for primary brain tumor (surgery and/or radiotherapy and/or chemotherapy)
- Patient is in follow-up care at the Institute of Oncology Ljubljana
- Availability for clinical endocrine and metabolic assessment
- Written informed consent provided by the participant or legal guardian (if applicable)
Who cannot join
- Active malignant disease requiring ongoing oncological treatment
- Severe acute illness preventing participation in endocrine/metabolic evaluation
- Inability to comply with study procedures or follow-up assessments
- Refusal or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Late Endocrine and Metabolic Consequences of Treatment of Primary Brain Tumors in Childhood
This interventional study evaluates the late endocrine and metabolic consequences of treatment of primary brain tumors in childhood. Childhood brain tumor survivors are at increased risk of developing long-term complications such as hormonal deficiencies, obesity, impaired growth, dyslipidemia, and other metabolic disorders, which may significantly affect long-term health and quality of life.
The aim of this study is to assess the prevalence and severity of endocrine and metabolic late effects in patients treated for brain tumors during childhood in Slovenia, and to identify associations with tumor localization, treatment modality, and physical performance.
Participants undergo structured clinical follow-up examinations and targeted endocrine and metabolic assessments according to the study protocol. The results of this study may help identify individuals at increased risk and improve long-term follow-up strategies, prevention, and management of late treatment-related complications.
Read the detailed description
This is a prospective interventional clinical study designed to evaluate the prevalence and severity of late endocrine and metabolic complications in survivors of primary brain tumors treated during childhood. Advances in pediatric oncology have improved survival, but many patients develop long-term health consequences that require systematic monitoring and early management.
The study includes patients who were treated for primary brain tumors during childhood and are followed at the Institute of Oncology Ljubljana. Participants undergo standardized clinical assessments as part of the study intervention, including evaluation of endocrine function, metabolic status, and physical competence. The study aims to determine the occurrence of late endocrine and metabolic disorders and to assess the relationship between these complications and clinical factors such as tumor localization, treatment modality (surgery, radiotherapy, chemotherapy), and overall functional status.
The primary objectives are:
to assess the prevalence of endocrine disorders (e.g., growth hormone deficiency, thyroid dysfunction, gonadal dysfunction, adrenal insufficiency) after childhood brain tumor treatment,
to evaluate metabolic consequences including obesity, dyslipidemia, insulin resistance, and other metabolic abnormalities,
to analyze associations between late effects and tumor localization, treatment characteristics, and physical competence of the participants.
The study is expected to provide important national data regarding late endocrine and metabolic outcomes in childhood brain tumor survivors in Slovenia and contribute to identification of patients at higher risk. The results may support development of improved follow-up protocols and preventive strategies, as well as timely referral for appropriate endocrine and metabolic treatment.
- Conditions
- Childhood Brain Tumors, Endocrine Disorders
- Being tested
- Endocrine and Metabolic Late Effects Assessment
- Keywords
- childhood brain tumors
- Medical subject headings
- Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocrine and Metabolic Late Effects AssessmentDiagnostic test
Participants undergo a structured endocrine and metabolic follow-up assessment after childhood brain tumor treatment. The intervention includes clinical examination, anthropometric measurements (height, weight, BMI), laboratory endocrine testing (pituitary and thyroid function, adrenal axis, gonadal hormones), metabolic testing (glucose and lipid profile), and evaluation of physical competence. The aim is to identify late endocrine and metabolic complications and assess their association with tumor location and previous treatment modalities.
| Study group | Role | What they receive |
|---|---|---|
| Late Effects Assessment Group | Experimental | Participants treated for primary brain tumors in childhood undergo a structured follow-up assessment to evaluate late endocrine and metabolic complications. The study includes clinical examination, anthropometric measurements, laboratory endocrine and metabolic testing, and evaluation of physical competence. Outcomes are analyzed in relation to tumor location and previous treatment modalities. Receives: Diagnostic Test: Endocrine and Metabolic Late Effects Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Endocrine and Metabolic Late Complications
Percentage of participants with at least one endocrine or metabolic late complication, defined as the presence of any endocrine disorder (growth hormone deficiency, hypothyroidism, adrenal insufficiency, hypogonadism) or any metabolic disorder (overweight/obesity defined by body mass index ≥25 kg/m², dyslipidemia defined by abnormal lipid profile, impaired glucose metabolism defined by fasting plasma glucose or HbA1c criteria), assessed by standardized clinical and laboratory evaluation.
Measured: During a single assessment visit (up to 1 day)
Secondary outcomes (7)
Prevalence of Endocrine Disorders
Percentage of participants diagnosed with at least one endocrine disorder (growth hormone deficiency, hypothyroidism, adrenal insufficiency, hypogonadism) based on hormonal laboratory testing and clinical evaluation.
Measured: During a single assessment visit (up to 1 day)
Prevalence of Metabolic Disorders
Percentage of participants diagnosed with at least one metabolic disorder (overweight/obesity defined by body mass index ≥25 kg/m², dyslipidemia defined by abnormal lipid profile, impaired glucose metabolism defined by fasting plasma glucose or HbA1c criteria).
Measured: During a single assessment visit (up to 1 day)
Association Between Tumor Location and Endocrine Disorders
Odds ratio (OR) for the presence (yes/no) of endocrine disorders according to tumor location, estimated using logistic regression analysis. Results will be reported as odds ratios (unitless) with 95% confidence intervals.
Measured: During a single assessment visit (up to 1 day)
Body Mass Index (BMI)
Body mass index (BMI) calculated as weight in kilograms divided by height in meters squared (kg/m²). Weight and height are measured during the same assessment visit and combined to calculate BMI as a single outcome value.
Measured: During a single assessment visit (up to 1 day)
Fasting Plasma Glucose
Fasting plasma glucose concentration measured using standard laboratory methods.
Measured: During a single assessment visit (up to 1 day)
LDL Cholesterol
Low-density lipoprotein (LDL) cholesterol concentration measured using standard laboratory methods.
Measured: During a single assessment visit (up to 1 day)
Physical Competence
Distance covered during a 6-minute walk test performed according to a standardized protocol, reported in meters (m).
Measured: During a single assessment visit (up to 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Jan 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Brain TumorsStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants who were treated for primary brain tumors in childhood undergo standardized endocrine and metabolic evaluation during follow-up, including clinical examination, laboratory testing, and assessment of physical competence, in order to identify late endocrine and metabolic complications and associated risk factors.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457255
- Sponsor's protocol ID
- OI-LATE-ENDO-MET-2023
- Other IDs
- ERID-KSOPR-0037/2023
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Endocrine and Metabolic Consequences of Treatment of Primary Brain Tumors in Childhood
- ClinicalTrials.gov ID
- NCT07457255
- Acronym / sponsor ID
- OI-LATE-ENDO-MET-2023
- Conditions
- Childhood Brain Tumors, Endocrine Disorders
- Keywords
- childhood brain tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 9 Mar 2026 (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.
This interventional study evaluates the late endocrine and metabolic consequences of treatment of primary brain tumors in childhood. Childhood brain tumor survivors are at increased risk of developing long-term complications such as hormonal deficiencies, obesity, impaired growth, dyslipidemia, and other metabolic disorders, which may significantly affect long-term health and quality of life.
The aim of this study is to assess the prevalence and severity of endocrine and metabolic late effects in patients treated for brain tumors during childhood in Slovenia, and to identify associations with tumor localization, treatment modality, and physical performance.
Participants undergo structured clinical follow-up examinations and targeted endocrine and metabolic assessments according to the study protocol. The results of this study may help identify individuals at increased risk and improve long-term follow-up strategies, prevention, and management of late treatment-related complications.
Detailed description
This is a prospective interventional clinical study designed to evaluate the prevalence and severity of late endocrine and metabolic complications in survivors of primary brain tumors treated during childhood. Advances in pediatric oncology have improved survival, but many patients develop long-term health consequences that require systematic monitoring and early management.
The study includes patients who were treated for primary brain tumors during childhood and are followed at the Institute of Oncology Ljubljana. Participants undergo standardized clinical assessments as part of the study intervention, including evaluation of endocrine function, metabolic status, and physical competence. The study aims to determine the occurrence of late endocrine and metabolic disorders and to assess the relationship between these complications and clinical factors such as tumor localization, treatment modality (surgery, radiotherapy, chemotherapy), and overall functional status.
The primary objectives are:
to assess the prevalence of endocrine disorders (e.g., growth hormone deficiency, thyroid dysfunction, gonadal dysfunction, adrenal insufficiency) after childhood brain tumor treatment,
to evaluate metabolic consequences including obesity, dyslipidemia, insulin resistance, and other metabolic abnormalities,
to analyze associations between late effects and tumor localization, treatment characteristics, and physical competence of the participants.
The study is expected to provide important national data regarding late endocrine and metabolic outcomes in childhood brain tumor survivors in Slovenia and contribute to identification of patients at higher risk. The results may support development of improved follow-up protocols and preventive strategies, as well as timely referral for appropriate endocrine and metabolic treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants who were treated for primary brain tumors in childhood undergo standardized endocrine and metabolic evaluation during follow-up, including clinical examination, laboratory testing, and assessment of physical competence, in order to identify late endocrine and metabolic complications and associated risk factors.
| Arm | Type | Receives |
|---|---|---|
| Late Effects Assessment Group | Experimental | Diagnostic Test: Endocrine and Metabolic Late Effects AssessmentParticipants treated for primary brain tumors in childhood undergo a structured follow-up assessment to evaluate late endocrine and metabolic complications. The study includes clinical examination, anthropometric measurements, laboratory endocrine and metabolic testing, and evaluation of physical competence. Outcomes are analyzed in relation to tumor location and previous treatment modalities. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- History of primary brain tumor diagnosed and treated in childhood
- Completed treatment for primary brain tumor (surgery and/or radiotherapy and/or chemotherapy)
- Patient is in follow-up care at the Institute of Oncology Ljubljana
- Availability for clinical endocrine and metabolic assessment
- Written informed consent provided by the participant or legal guardian (if applicable)
Key exclusion criteria (4 listed)
- Active malignant disease requiring ongoing oncological treatment
- Severe acute illness preventing participation in endocrine/metabolic evaluation
- Inability to comply with study procedures or follow-up assessments
- Refusal or inability to provide informed consent
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 |
|---|---|---|
| Endocrine and Metabolic Late Effects AssessmentParticipants undergo a structured endocrine and metabolic follow-up assessment after childhood brain tumor treatment. The intervention includes clinical examination, anthropometric measurements (height, weight, BMI), laboratory endocrine testing (pituitary and thyroid function, adrenal axis, gonadal hormones), metabolic testing (glucose and lipid profile), and evaluation of physical competence. The aim is to identify late endocrine and metabolic complications and assess their association with tumor location and previous treatment modalities. | Diagnostic test | Late Effects Assessment Group |
Primary outcome
Prevalence of Endocrine and Metabolic Late Complications
Time frame: During a single assessment visit (up to 1 day)
Percentage of participants with at least one endocrine or metabolic late complication, defined as the presence of any endocrine disorder (growth hormone deficiency, hypothyroidism, adrenal insufficiency, hypogonadism) or any metabolic disorder (overweight/obesity defined by body mass index ≥25 kg/m², dyslipidemia defined by abnormal lipid profile, impaired glucose metabolism defined by fasting plasma glucose or HbA1c criteria), assessed by standardized clinical and laboratory evaluation.
7 secondary outcomes
Prevalence of Endocrine Disorders
Time frame: During a single assessment visit (up to 1 day)
Prevalence of Metabolic Disorders
Time frame: During a single assessment visit (up to 1 day)
Association Between Tumor Location and Endocrine Disorders
Time frame: During a single assessment visit (up to 1 day)
Body Mass Index (BMI)
Time frame: During a single assessment visit (up to 1 day)
Fasting Plasma Glucose
Time frame: During a single assessment visit (up to 1 day)
LDL Cholesterol
Time frame: During a single assessment visit (up to 1 day)
Physical Competence
Time frame: During a single assessment visit (up to 1 day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endocrine and Metabolic Late Effects Assessment in people with Childhood Brain Tumors and Endocrine Disorders, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Endocrine and Metabolic Late Complications (time frame: During a single assessment visit (up to 1 day)). 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 9 Mar 2026.