NCT06380387 Whole Body Metabolism in Children Before and After Treatment of CNS Tumor
| NCT ID | NCT06380387 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | CNS Tumor, Childhood |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-03-23 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-03-23 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
At the center of pediatric oncology in Copenhagen the investigators experience that the children with brain tumor, more or less have a healthy body with normal skeletal muscle mass and are physical active to the same level as their friends at the same age. The treatment period for brain tumor is approximately two years. After the treatment period, the children are more sedative with less interest in coming out doing physical activities and thus the investigators suspect that they have altered hormonal response, low skeletal muscle mass and perhaps are in risk of developing metabolic syndrome. By comparing children with newly diagnosed CNS tumor with children finished treated for CNS tumor, we wish to describe the metabolic path during the approximately two years treatment period these children go through. These results will also be compared with results from healthy controls. The investigators aim to include 10 children (aged 6-18 years) with newly diagnosed CNS tumor, 10 children (aged 6-18 years) finished treated for CNS tumor and 10 healthy controls (aged 6-18 years). By using stable isotope technique the investigators will investigate systemic fat, glucose and protein metabolism together with liver protein degradation and glucose production. Furthermore, by using DXA scan the investigators will describe the quality and distribution of skeletal muscle. Lastly, the investigators will determine the skeletal muscle signal pathway and metabolism in skeletal muscle via the Bergström biopsy technique in vastus lateralis.
Eligibility Criteria
Inclusion Criteria: * Patient group A: Children with newly diagnosed CNS tumor, included just before the start of treatment or right after possible surgery. * Patient group B: Children who have completed treatment for a CNS tumor within the last month. * Healthy controls: Children admitted to the EMU because of either * Suspected convulsions * Nocturnal EEG changes * 6-18 years * Signed informed consent to participation in the trial. Exclusion Criteria: * Inability to understand the purpose of the trial or cooperate in the conduction of the experiments. For the children this will concern of course the parents or the guardians of the child. * Competing conditions at risk of compromising the results of the study. * Participation in other trials that may interfere with the results. * Intake of medications that may interfere with the results, evaluated by investigator. * Pregnancy or breastfeeding.
Frequently Asked Questions
Who can join the NCT06380387 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 18 Years, studying CNS Tumor, Childhood. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06380387 currently recruiting?
Yes, NCT06380387 is actively recruiting participants. Visit ClinicalTrials.gov or contact Rigshospitalet, Denmark to inquire about joining.
Where is the NCT06380387 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT06380387 clinical trial?
NCT06380387 is sponsored by Rigshospitalet, Denmark. The trial plans to enroll 30 participants.