Endocrine and Metabolic Late Effects After Childhood Brain Tumor Treatment

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

This prospective single-group clinical study evaluates late endocrine and metabolic consequences in survivors of primary brain tumors treated during childhood in Slovenia.

Participants were treated for a primary brain tumor between 2008 and 2018 while aged 0 to 18 years and survived for at least 5 years after diagnosis. They undergo a standardized multidisciplinary assessment during follow-up. The assessment includes review of medical history and previous cancer treatment, anthropometric measurements, blood pressure measurement, clinical endocrine evaluation, and laboratory assessment of endocrine and metabolic markers. Available results of bone mineral density and vascular assessments are also reviewed, and additional clinically indicated assessments may be performed as part of routine follow-up.

The study aims to determine the frequency and severity of endocrine and metabolic late effects and to examine their association with tumor type and location, treatment characteristics, and physical functioning. The findings may support earlier identification of survivors at increased risk and improve individualized long-term follow-up and treatment.

Study Overview

• Status: Completed
• Conditions: Metabolic Diseases; Endocrine System Diseases; Brain Neoplasms
• Intervention / Treatment: Diagnostic test: Comprehensive Endocrine and Metabolic Late-Effects Assessment

Detailed Description

Survival after primary brain tumors diagnosed in childhood has improved substantially. However, survivors may develop long-term endocrine, metabolic, neurological, psychological, and cardiovascular complications. These late effects may appear several years after completion of treatment and may negatively affect health, quality of life, and life expectancy.

This prospective single-group study includes individuals who were treated for a primary brain tumor in Slovenia between 2008 and 2018 while aged 0 to 18 years and who survived for at least 5 years after diagnosis.

Participants undergo a standardized multidisciplinary late-effects assessment during follow-up by oncology, neurology, and endocrinology specialists. Information on tumor type and location, age at diagnosis, treatment modalities, date of treatment completion, current therapy, and relevant late effects is collected from medical records and clinical evaluation.

The assessment includes body weight, height, waist and hip circumference, arm span, sitting height, repeated blood pressure measurements, and clinical assessment of pubertal development when applicable. Endocrine and metabolic laboratory parameters may include growth-related hormones, thyroid hormones, gonadotropins, sex hormones, cortisol, insulin, glucose, lipid profile, liver enzymes, vitamin D, and other clinically relevant markers.

Where available or clinically indicated, the assessment also includes bone mineral density and body composition measurement by dual-energy X-ray absorptiometry, carotid intima-media thickness measurement, and evaluation of arterial stiffness by pulse wave velocity. No investigational medicinal product is administered.

The primary objective is to determine the occurrence and severity of endocrine and metabolic late effects after treatment of childhood brain tumors. Additional analyses evaluate associations between these late effects and tumor location, tumor type, treatment modality, age at diagnosis, and physical functioning.

The results are intended to support the identification of survivors at increased risk and to contribute to the development of individualized long-term monitoring, prevention, and treatment strategies.

• 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
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Individuals treated for a primary brain tumor in Slovenia between 2008 and 2018 while aged 0 to 18 years.
• Survival for at least 5 years after the diagnosis of a primary brain tumor.
• Written informed consent provided by the participant or, when applicable, by a parent or legal guardian.

Exclusion Criteria:

• Failure to meet the inclusion criteria.
• Absence of written informed consent from the participant or, when applicable, from a parent or legal guardian.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• 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: Comprehensive Late-Effects Assessment; All participants undergo the same standardized multidisciplinary assessment of endocrine and metabolic late effects after treatment of a primary brain tumor during childhood. The assessment includes review of medical history and previous treatment, anthropometric measurements, blood pressure measurement, clinical endocrine evaluation, laboratory assessment, and evaluation of bone and vascular health when available or clinically indicated. There is no comparator group.

Diagnostic test: Comprehensive Endocrine and Metabolic Late-Effects Assessment; Participants undergo a standardized assessment to identify endocrine and metabolic late effects after childhood brain tumor treatment. The assessment includes medical history review, anthropometric measurements, repeated blood pressure measurements, clinical evaluation of pubertal and endocrine status, and laboratory evaluation of endocrine and metabolic markers. Bone mineral density, carotid intima-media thickness, and pulse wave velocity are evaluated when available or clinically indicated. No investigational medicinal product is administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Endocrine and Metabolic Late Effects	The number and percentage of participants with at least one endocrine or metabolic late effect identified during the standardized multidisciplinary assessment will be reported. Late effects are determined from medical history, clinical endocrine evaluation, anthropometric measurements, blood pressure measurements, and laboratory findings, including growth-related, thyroid, gonadal, adrenal, glucose, insulin, lipid, liver, and vitamin D parameters.	At completion of the multidisciplinary late-effects assessment, through December 31, 2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association of Endocrine and Metabolic Late Effects With Tumor and Treatment Characteristics	The occurrence and severity of endocrine and metabolic late effects will be evaluated according to tumor type and location, age at diagnosis, and treatment characteristics, including surgery, chemotherapy, and radiotherapy.	At completion of the multidisciplinary late-effects assessment, through December 31, 2025

Collaborators and Investigators

• Sponsor: Institute of Oncology Ljubljana
• Investigators: Principal Investigator: Lorna Zadravec Zaletel, MD, PhD, Institute of Oncology Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2023
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: July 15, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Late Effects of Cancer Treatment; Childhood Brain Tumor Survivors; Endocrine Late Effects
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Nutritional and Metabolic Diseases; Brain Neoplasms; Metabolic Diseases; Endocrine System Diseases
• Other Study ID Numbers: OI-LATE-BT-2023-01

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