Brain NeoplasmsNCT07716579
Assessment of Endocrine and Metabolic Late Effects After Childhood Brain Tumor Treatment
A study testing Study-Specific Endocrine and Metabolic Late-Effects Assessment in people with Brain Neoplasms and Endocrine System Diseases, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
This prospective, single-group interventional study evaluates endocrine and metabolic late effects in survivors of primary brain tumors treated during childhood. According to the study protocol, participants were prospectively assigned to undergo the Study-Specific Endocrine and Metabolic Late-Effects Assessment. Read more about this study
- Who is it for?
- Ages 5 to 35 years
- Conditions the study is for
- Brain Neoplasms, Endocrine System Diseases, Metabolic Diseases
- What is being tested?
- Study-Specific Endocrine and Metabolic Late-Effects Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSlovenia
- Study dates
- 3 Jul 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Failure to meet the inclusion criteria.
- Absence of written informed consent from the participant or, when applicable, from a parent or legal guardian.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Late Endocrine and Metabolic Consequences of Treatment of Primary Brain Tumors in Childhood
This prospective, single-group interventional study evaluates endocrine and metabolic late effects in survivors of primary brain tumors treated during childhood. According to the study protocol, participants were prospectively assigned to undergo the Study-Specific 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. The purpose of the study was to identify the frequency and severity of endocrine and metabolic late effects and to evaluate their associations with tumor characteristics, previous cancer treatment, age at diagnosis, and physical functioning.
Read the 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.
- Being tested
- Study-Specific Endocrine and Metabolic Late-Effects Assessment
- Keywords
- Childhood Brain Tumor Survivors, Late Effects of Cancer Treatment, Endocrine Late Effects
- Medical subject headings
- Brain Neoplasms, Endocrine System Diseases, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study-Specific Endocrine and Metabolic Late-Effects AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study-Specific Endocrine and Metabolic Late-Effects Assessment | Experimental | 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. Receives: Other: Study-Specific Endocrine and Metabolic Late-Effects Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Percentage of Participants With at Least One Endocrine or Metabolic Late Effect
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.
Measured: Baseline
Secondary outcomes (1)
Number and Percentage of Participants With Endocrine or Metabolic Late Effects by Tumor and Treatment Characteristics
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start3 Jul 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants were prospectively assigned to one protocol-defined study intervention: a study-specific endocrine and metabolic late-effects assessment. The same assessment strategy was used for all participants. There was no comparator group and no randomization.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorna Zadravec Zaletel, MD, PhD, Principal investigator, Institute of Oncology Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716579
- Sponsor's protocol ID
- OI-LATE-BT-2023-01
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Endocrine and Metabolic Consequences of Treatment of Primary Brain Tumors in Childhood
- ClinicalTrials.gov ID
- NCT07716579
- Acronym / sponsor ID
- OI-LATE-BT-2023-01
- Keywords
- Childhood Brain Tumor Survivors, Late Effects of Cancer Treatment, Endocrine Late Effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, single-group interventional study evaluates endocrine and metabolic late effects in survivors of primary brain tumors treated during childhood. According to the study protocol, participants were prospectively assigned to undergo the Study-Specific 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. The purpose of the study was to identify the frequency and severity of endocrine and metabolic late effects and to evaluate their associations with tumor characteristics, previous cancer treatment, age at diagnosis, and physical functioning.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants were prospectively assigned to one protocol-defined study intervention: a study-specific endocrine and metabolic late-effects assessment. The same assessment strategy was used for all participants. There was no comparator group and no randomization.
| Arm | Type | Receives |
|---|---|---|
| Study-Specific Endocrine and Metabolic Late-Effects Assessment | Experimental | Other: Study-Specific Endocrine and Metabolic Late-Effects AssessmentParticipants 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. |
Who may qualify
- Ages
- 5 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Failure to meet the inclusion criteria.
- Absence of written informed consent from the participant or, when applicable, from a parent or legal guardian.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study-Specific Endocrine and Metabolic Late-Effects AssessmentAccording 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. | Other | Study-Specific Endocrine and Metabolic Late-Effects Assessment |
Primary outcome
Number and Percentage of Participants With at Least One Endocrine or Metabolic Late Effect
Time frame: Baseline
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.
1 secondary outcome
Number and Percentage of Participants With Endocrine or Metabolic Late Effects by Tumor and Treatment Characteristics
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorna Zadravec Zaletel, MD, PhD principal investigator
Institute of Oncology Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study-Specific Endocrine and Metabolic Late-Effects Assessment in people with Brain Neoplasms and Endocrine System Diseases, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Percentage of Participants With at Least One Endocrine or Metabolic Late Effect (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.