Assessment of Endocrine and Metabolic Late Effects After Childhood Brain Tumor Treatment
Late Endocrine and Metabolic Consequences of Treatment of Primary Brain Tumors in Childhood
Study Overview
Status
Intervention / Treatment
Detailed Description
Survivors of primary brain tumors treated during childhood may develop endocrine, metabolic, neurological, psychological, and cardiovascular late effects several years after completion of cancer treatment.
This prospective, single-group interventional study included individuals who had been treated for a primary brain tumor in Slovenia between 2008 and 2018 while aged 0 to 18 years and who had survived for at least 5 years after diagnosis.
Following enrollment and informed consent, all participants were prospectively assigned, according to the study protocol, to undergo the same Study-Specific Endocrine and Metabolic Late-Effects Assessment. Participation in the study determined the standardized manner and intensity with which the protocol-defined procedures were performed; participants would not otherwise necessarily have received the same assessment package during routine clinical follow-up.
The protocol-defined assessment included review of medical history and previous cancer treatment, measurement of body weight, height, waist and hip circumference, arm span and sitting height, repeated blood pressure measurements, clinical assessment of endocrine and pubertal status, and fasting laboratory testing of endocrine and metabolic markers.
The study-specific assessment also included vascular evaluation by measurement of carotid intima-media thickness.When the relevant results were not already available, dual-energy X-ray absorptiometry for the assessment of bone mineral density and body composition, and pulse wave velocity assessment, were performed or arranged according to the study protocol.
Medical record data on tumor type and location, age at diagnosis, treatment modalities, date of treatment completion, current therapy, and previously identified late effects were also collected. No investigational medicinal product was administered.
The primary objective was to identify the occurrence and severity of endocrine and metabolic late effects following treatment of childhood brain tumors. Additional analyses evaluated associations between the identified late effects and tumor location, tumor type, treatment modality, age at diagnosis, and physical functioning.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Ljubljana, Slovenia, 1000
- Institute of Oncology Ljubljana
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Study-Specific Endocrine and Metabolic Late-Effects Assessment
Participants were prospectively assigned to undergo the protocol-defined endocrine and metabolic late-effects assessment.
The assessment included anthropometric measurements, repeated blood pressure measurements, clinical endocrine evaluation, fasting laboratory testing, and protocol-defined bone and vascular assessments.
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According to the study protocol, participants underwent a study-specific assessment to identify endocrine and metabolic late effects after treatment of a primary brain tumor during childhood.
The assessment included anthropometric measurements, repeated blood pressure measurements, clinical assessment of endocrine and pubertal status, and fasting laboratory testing of endocrine and metabolic markers.
Vascular assessment included measurement of carotid intima-media thickness.
Bone mineral density, body composition, and pulse wave velocity assessments were performed or arranged according to the protocol when the relevant results were not already available.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number and Percentage of Participants With at Least One Endocrine or Metabolic Late Effect
Time Frame: Baseline
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Number and percentage of participants with at least one endocrine or metabolic late effect identified by the protocol-defined Study-Specific Endocrine and Metabolic Late-Effects Assessment.
Late effects were identified using medical history, clinical endocrine evaluation, anthropometric measurements, repeated blood pressure measurements, and laboratory findings, including growth-related, thyroid, gonadal, adrenal, glucose, insulin, lipid, liver, and vitamin D parameters.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number and Percentage of Participants With Endocrine or Metabolic Late Effects by Tumor and Treatment Characteristics
Time Frame: Baseline
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Number and percentage of participants with endocrine or metabolic late effects, summarized according to tumor type and location, age at diagnosis, and previous treatment characteristics, including surgery, chemotherapy, and radiotherapy.
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lorna Zadravec Zaletel, MD, PhD, Institute of Oncology Ljubljana
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OI-LATE-BT-2023-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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