Late Endocrine and Metabolic Consequences After Childhood Brain Tumor Treatment

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.

Study Overview

• Status: Completed
• Conditions: Endocrine Disorders; Childhood Brain Tumors
• Intervention / Treatment: Diagnostic test: Endocrine and Metabolic Late Effects Assessment

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Institute of Oncology Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Late Effects Assessment Group; 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.

Diagnostic test: Endocrine and Metabolic Late Effects Assessment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During a single assessment visit (up to 1 day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	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.	During a single assessment visit (up to 1 day)
Fasting Plasma Glucose	Fasting plasma glucose concentration measured using standard laboratory methods.	During a single assessment visit (up to 1 day)
LDL Cholesterol	Low-density lipoprotein (LDL) cholesterol concentration measured using standard laboratory methods.	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).	During a single assessment visit (up to 1 day)

Collaborators and Investigators

• Sponsor: Institute of Oncology Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: childhood brain tumors
• Additional Relevant MeSH Terms: Endocrine System Diseases
• Other Study ID Numbers: OI-LATE-ENDO-MET-2023; ERID-KSOPR-0037/2023 (Other Identifier: Institute of Oncology Ljubljana - KSOPR (Commission for Scientific Review of Research Protocols))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No