NCT04066465Recruiting
Neurocognitive Function After Proton Therapy in Children and Adolescents
Neurocognitive Function /executive Functions After Proton Therapy in Children and Adolescents.
Source: ClinicalTrials.gov · Last updated 6 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 90 (estimated)
- First submitted
- 19 Jun 2019
- Start date
- 1 Sept 2019
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Technische Universität Dresden
- Diseases
- Childhood cancers
- NCT number
- NCT04066465
What you commit to
- Study type: Observational
- Planned participants: 90
- From 1 Sept 2019 to the primary completion date, 31 Dec 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient receives intrathecal chemotherapy
Other illness
- Chronic diseases that may affect the results of neurological EEG and neuropsychological examinations.
Age
- 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.)
Other
- Brain metastases from extracerebral tumors
- pure palliative treatment concept
- The patient is not able to perform repeated neuropsychological tests (approx. 1 hour per examination).
- 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
Who the study is looking for
- 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)
Criteria the registry did not label
- Indication: Patients with primary brain tumor
Age in the registry: 8 years to 18 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Carl GUstav Carus Dresden, Department of Radiation Therapy and Radiation Oncology Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| University Hospital Carl GUstav Carus Dresden, Child and adolescent psychiatry and psychotherapy Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| University Hospital Carl GUstav Carus Dresden, Department of Neuropaediatrics Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.