NCT04066465 Neurocognitive Function After Proton Therapy in Children and Adolescents
| NCT ID | NCT04066465 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Technische Universität Dresden |
| Condition | Primary Brain Tumor |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2019-09-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2019-09-01 with a primary completion date of 2025-12-31.
⚠ 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
Brain tumors are the second most frequent malignant diseases in children and adolescents. In the study the short and medium term consequences of proton therapy on cognitive processes in particular on executive functions in pediatric patients shall be highlighted/analysed/evalutated. In a second step, these results are to be compared with 1. a group of children and adolescents who had only /exclusively had operative therapy and 2. with a healthy control group. Thus, the extent to which these treatment options differ in terms of their short and medium-term effect is assessed. Methods of neurocognitive/neurophysiology brain research approaches are applied that may potentially visualize even small / subtle changes in mental activities/neurocognitive function. Therefore the effects of treatment can be evaluated and the neuropsychological outcome of children and adolescents with brain tumors can be improved.
Eligibility Criteria
Indication: Patients with primary brain tumor Inclusion Criteria: * all groups: Patients in childhood and adolescence between 8-18 years of age * all groups: no prior radiotherapy of the brain, * all groups: The patient is able to perform repeated neuropsychological tests (approx. 1 hour per examination), * all groups: corrected visual acuity not impaired below 80% or no subjective indication of visual acuity impairment, * all groups: corrected hearing not impaired or no subjective evidence of hearing impairment, * all groups: Patient is able to perform follow-up examinations, * all groups: written consent of the patient/parent or guardian. * Brain tumour groups with/without irradiation: Primary brain tumour * brain tumor groups with/without radiation: curative or long-term palliative intention of therapy * brain tumor groups with/without irradiation: life expectancy \> 3 years * Irradiation group only: planned proton therapy with a local radiation dose of at least 40 Gy(RBE) Exclusion Criteria: * Patients under 8 or over 18 years of age (We limit the study to children over 8 years of age due to the fact that executive functions mature very late.) * Brain metastases from extracerebral tumors * Patient receives intrathecal chemotherapy * pure palliative treatment concept * The patient is not able to perform repeated neuropsychological tests (approx. 1 hour per examination). * Chronic diseases that may affect the results of neurological EEG and neuropsychological examinations. * The patient is not in a position to perform follow-up examinations * no written consent of the patient / parent or legal guardian * Participation in an intervention study whose procedures contradict those of the present study
Contact & Investigator
Mechthild Krause, Prof. Dr.
STUDY CHAIR
University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)
Frequently Asked Questions
Who can join the NCT04066465 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 18 Years, studying Primary Brain Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04066465 currently recruiting?
Yes, NCT04066465 is actively recruiting participants. Contact the research team at mechthild.krause@uniklinikum-dresden.de for enrollment information.
Where is the NCT04066465 trial being conducted?
This trial is being conducted at Dresden, Germany, Dresden, Germany, Dresden, Germany.
Who is sponsoring the NCT04066465 clinical trial?
NCT04066465 is sponsored by Technische Universität Dresden. The principal investigator is Mechthild Krause, Prof. Dr. at University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK). The trial plans to enroll 90 participants.