Clinical trial NCT02559752: Computer-based Neurocognitive Assessment in Children With Central Nervous System Tumors Receiving Proton Beam Radiation Therapy
Official title: Computer-based Neurocognitive Assessment in Children With Central Nervous System Tumors Receiving Proton Beam Radiation Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Central Nervous System
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants seen at Washington University School of Medicine.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary CNS tumor or diagnosis of metastatic disease to the CNS with an expected overall survival of \> 1 year. Any prior treatment (chemo, XRT, or surgery) is allowed.
* Planning to receive PBRT to treat the CNS tumor. Patients who have already received PBRT for this disease may also be enrolled provided they completed the NIH Toolbox Cognitive Battery prior to the first week of radiation therapy.
* Between 4 and 21 years of age (inclusive).
* Life expectancy of at least one year.
* Absence of visual impairment that would impede computer testing.
* No secondary health conditions that would impact cognitive functioning (e.g. psychiatric or developmental disability unrelated to cancer).
* Able to understand and willing to sign IRB-approved written informed consent document (or signature of legally authorized representative).

Primary outcomes:
measure: Feasibility of obtaining serial computer-based neurocognitive testing as measured by an acceptance rate of 60% of eligible patients.
timeFrame: At the completion of enrollment of all patients (estimated to be 9 years)
measure: Feasibility of obtaining serial computer-based neurocognitive testing as measured by an implementation rate of 80% among survivors
timeFrame: 12 months
measure: Feasibility of obtaining serial computer-based neurocognitive testing as measured by an implementation rate of 80% among survivors
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Stephanie Perkins, M.D.
role: PRINCIPAL_INVESTIGATOR
References: