Late Endocrine and Metabolic Consequences After Childhood Brain Tumor Treatment

NCT07457255 | Completed

• 2 other identifiers: OI-LATE-ENDO-MET-2023ERID-KSOPR-0037/2023
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Childhood Brain Tumors; Endocrine Disorders

Keywords

childhood brain tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Prevalence of Endocrine Disorders

  During a single assessment visit (up to 1 day)

• Prevalence of Metabolic Disorders

  During a single assessment visit (up to 1 day)

• Association Between Tumor Location and Endocrine Disorders

  During a single assessment visit (up to 1 day)

• Body Mass Index (BMI)

  During a single assessment visit (up to 1 day)

• Fasting Plasma Glucose

  During a single assessment visit (up to 1 day)

Study Arms (1)

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.

Diagnostic Test: Endocrine and Metabolic Late Effects Assessment

Interventions

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.

Late Effects Assessment Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: March 9, 2026
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)