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NCT02559752 · ClinicalTrials.gov registry record
Computer-based Neurocognitive Assessment in Children With Central Nervous System Tumors Receiving Proton Beam Radiation Therapy
A clinical trial of Central Nervous System, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- 80
- Enrollment target
- 1
- Study location
NCT02559752: Recruiting study of Central Nervous System, sponsored by Washington University School of Medicine.
NCT02559752 is a study of Central Nervous System that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 80 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02559752, a study of Central Nervous System, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will explore neurocognitive performance in pediatric brain tumor patients receiving proton beam radiation therapy (PBRT). The investigators goal is to gather baseline neurocognitive testing prior to the completion of the first week of radiation therapy along with follow-up testing 6-12 months after the completion of radiation and serial annual testing thereafter. With these data the investigators plan to evaluate the effects of PBRT on neurocognitive performance as it relates to patients' age at diagnosis, tumor location, and radiation dose. Modeling studies have demonstrated that PBRT could improve neurocognitive outcomes, but there is a paucity of prospectively-collected patient data. The investigators are uniquely positioned to address this important question given the busy pediatric central nervous system (CNS) tumor service, the delivery of proton therapy at the S. Lee Kling Proton Therapy Center at Barnes-Jewish Hospital, and the multi-disciplinary research team with extensive experience into the late effects of therapy as it relates to neurocognition.
Primary Outcome
The acceptance rate will be a proportion of those who consent to participation over the total number of eligible and approached participants. The 60% acceptance rate is chosen because previous behavioral science intervention study participation in pediatric hematology and oncology ranges from 42% to 90%.
Conditions Studied
Interventions
- OTHER NIH Toolbox Cognitive Battery
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2015-10-13 |
| Est. Completion | 2031-04-30 |
What NCT02559752 shows while recruiting
NCT02559752 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target.
The record links to 1 condition, with Central Nervous System appearing as the primary indexed condition, and to 1 intervention - of which NIH Toolbox Cognitive Battery is the first listed.
NCT02559752 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT02559752 about?
NCT02559752 is a clinical study titled "Computer-based Neurocognitive Assessment in Children With Central Nervous System Tumors Receiving Proton Beam Radiation Therapy". This study will explore neurocognitive performance in pediatric brain tumor patients receiving proton beam radiation therapy (PBRT). The investigators goal is to gather baseline neurocognitive testing prior to the completion of the first week of radiation therapy along with follow-up testing 6-12 mo...
What is the current status of trial NCT02559752?
This trial is currently recruiting. The enrollment target is 80 participants. The study started on 2015-10-13. Estimated completion is 2031-04-30.
What conditions does trial NCT02559752 study?
This clinical trial studies the following conditions: Central Nervous System.
What interventions are being tested in trial NCT02559752?
The interventions under investigation include: NIH Toolbox Cognitive Battery (OTHER).
Who is sponsoring clinical trial NCT02559752?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02559752 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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