Clinical Trial

Neurocognitive Function After Proton Therapy in Children and Adolescents

Study acronym: ELBE-ProKids
Recruiting
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Record status
This record was last updated February 6, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2019-08-22; most recent amendment 2025-02-04.
Status change: Not Yet Recruiting → Recruiting 2019-10-28
Trial Details
NCT Number NCT04066465
Lead Sponsor Technische Universität Dresden
Collaborators: Gert und Susanna Mayer Stiftung
Conditions Primary Brain Tumor
Enrollment 90 participants
Start Date 2019-09-01
Primary Completion 2025-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-02-06