Endocrine and Metabolic Late Effects After Childhood Brain Tumor Treatment

NCT07716579 | Completed

• 1 other identifier: OI-LATE-BT-2023-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Neoplasms; Endocrine System Diseases; Metabolic Diseases

Keywords

Childhood Brain Tumor Survivors; Late Effects of Cancer Treatment; Endocrine Late Effects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Association of Endocrine and Metabolic Late Effects With Tumor and Treatment Characteristics

  At completion of the multidisciplinary late-effects assessment, through December 31, 2025

Study Arms (1)

Comprehensive Late-Effects Assessment

EXPERIMENTAL

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

Interventions

Comprehensive Endocrine and Metabolic Late-Effects Assessment DIAGNOSTIC_TEST

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.

Comprehensive Late-Effects Assessment

Eligibility Criteria

• Age: 5 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Absence of written informed consent from the participant or, when applicable, from a parent or legal guardian.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Brain Neoplasms; Endocrine System Diseases; Metabolic Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Nutritional and Metabolic Diseases

Study Officials

• Lorna Zadravec Zaletel, MD, PhD

  Institute of Oncology Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: All participants undergo the same standardized multidisciplinary assessment of endocrine and metabolic late effects after treatment of a primary brain tumor during childhood. There is no comparator group and no randomization.

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 21, 2026
• Study Start: July 3, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)