Clinical Trial: Cognitive Biomarkers in Pediatric Brain Tumor Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Cognitive Biomarkers in Pediatric Brain Tumor Patients

Brief Summary: The investigators will focus on two cohorts of brain tumor patients aged, 4-18 years, to answer two critical questions: 1) Can the investigators acquire high quality data relevant to cognitive function during the peri-diagnostic period and, 2) can the investigators develop predictive models for cognitive outcomes using serial examination of functional imaging and cognitive function. Any patient with a newly diagnosed brain tumor aged 4-18 will be eligible for enrollment in cohort 1. Only patients with previously diagnosed tumors of the posterior fossa will be eligible for cohort 2. The rationale for of the focus on these patients is that first, the posterior fossa is the most common location for pediatric brain tumors and therefore this focus will impact the largest segment of this patient population. Second, three tumors commonly occur here, medulloblastoma, ependymoma and pilocytic astrocytoma. These are treated with surgery, radiation and chemotherapy (medulloblastoma), surgery and radiation therapy (ependymoma) or surgery only (pilocytic astrocytoma). Thus, this focus will provide a platform to analyze the impact that different tumor types and different standard treatments have on cognitive dysfunction. Finally, the fact that all subjects will have tumors of the same brain region will control for the effect that tumor location will have on cognitive testing and rsfcMRI. Here, repeated evaluations on and off therapy will provide the necessary data points to establish trajectories of cognitive development and recovery in this population.

Detailed Summary:
Sponsor: Washington University School of Medicine

Current Primary Outcome:

  • Identify reliable peri-diagnostic estimators of cognition as measured by neurocognitive testing [ Time Frame: Peri-diagnostic period (from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later) ]
  • Identify reliable peri-diagnostic estimators of cognition as measured by advanced resting-state functional connectivity MRI (rsfcMRI) data [ Time Frame: Peri-diagnostic period (from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later) ]
  • Predictors of cognitive recovery in children as determined by multiplexed analyses of a combination of potential biomarkers across multiple modalities (rsfcMRI, structural MRI, NIH Toolbox, patient demographics, treatment information) [ Time Frame: Up to 27 months ]
    As dictated by information theory, properly combining predictors across modalities must increase the accuracy of the prediction algorithm, unless a given modality contains no information about the question of interest (in this case, long-term cognitive outcomes).
  • Identify reliable peri-diagnostic estimators of brain function as measured by neurocognitive testing [ Time Frame: Peri-diagnostic period (from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later) ]
  • Identify reliable peri-diagnostic estimators of brain function as measured by advanced resting-state functional connectivity MRI (rsfcMRI) data [ Time Frame: Peri-diagnostic period (from first presentation to 2 weeks post-diagnosis or two weeks post-op, whichever is later) ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Washington University School of Medicine

Dates:
Date Received: September 19, 2016
Date Started: October 26, 2016
Date Completion: January 30, 2022
Last Updated: March 3, 2017
Last Verified: March 2017