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NCT Number: NCT07457255

Late Endocrine and Metabolic Consequences After Childhood Brain Tumor Treatment

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.

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Key information

Conditions

Childhood Brain Tumors Endocrine Disorders Endocrine System Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endocrine and Metabolic Late Effects Assessment

Diagnostic 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Prevalence of Endocrine Disorders

    Time frame: During a single assessment visit (up to 1 day)

    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.

  2. Prevalence of Metabolic Disorders

    Time frame: During a single assessment visit (up to 1 day)

    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).

  3. Association Between Tumor Location and Endocrine Disorders

    Time frame: During a single assessment visit (up to 1 day)

    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.

  4. Body Mass Index (BMI)

    Time frame: During a single assessment visit (up to 1 day)

    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.

  5. Fasting Plasma Glucose

    Time frame: During a single assessment visit (up to 1 day)

    Fasting plasma glucose concentration measured using standard laboratory methods.

  6. LDL Cholesterol

    Time frame: During a single assessment visit (up to 1 day)

    Low-density lipoprotein (LDL) cholesterol concentration measured using standard laboratory methods.

  7. Physical Competence

    Time frame: During a single assessment visit (up to 1 day)

    Distance covered during a 6-minute walk test performed according to a standardized protocol, reported in meters (m).

Sponsors and collaborators

Lead sponsor

Institute of Oncology Ljubljana

Other

Registry information

Official study title

Late Endocrine and Metabolic Consequences of Treatment of Primary Brain Tumors in Childhood

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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