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Completed

NCT Number: NCT07716579

Endocrine and Metabolic Late Effects After Childhood Brain Tumor Treatment

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.

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Key information

Age range

5 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

Primary outcomes

  1. Prevalence of Endocrine and Metabolic Late Effects

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

    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.

Secondary outcomes

  1. Association of Endocrine and Metabolic Late Effects With Tumor and Treatment Characteristics

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

    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.

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
Jul 21, 2026
Registry last updated
Jul 21, 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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