A prospective, longitudinal, multi-Institutional, observational study to correlate quantitative changes of the human structural and functional connectome in adults undergoing treatment for grades 2-4 gliomas
Categories (click each to see list of all clinical trials associated with that category): Brain/Neuro (ONC), Surgical Oncology (SURGONC)
Current Status: Open
Phase: N/A (Cancer Control)
Principal Investigator: Aizenberg, Michele
Contact Information:
Jill Skorupa
jilskorupa@unmc.edu
Summary
Primary Objective
To determine how glioma resection impacts the brain connectome by assessing preoperative and postoperative neurological deficits (loss of function), tracking neurological recovery, repair of brain pathways/networks, neuroplasticity (gain of function), and neuropsychological outcomes.
Secondary Objectives
To validate connectome measures (Global efficiency, Network index, FWHM) as correlates of glioma prognosis, progression, and response to therapy.
To determine, based on connectome measures, whether connectome alterations: 1) can be used to stratify risk and 2) have a predictive value of a positive (good) or negative (poor) surgical outcome, as measured by overall survival (OS), progression free survival (PFS), Karnofsky performance status (KPS), Barthel disability index (BDI), EQ-5D, Hamilton Depression Rating Scale (HDRS), and neurocognitive function.
Connectomic metrics will be linked to:
o clinical end-points: KPS, BDI, neurocognitive function, time to recurrence, PFS and OS.
o molecular markers and drivers of glioma growth: Ki-67, IDH, EGFR, TP53, MGMT, ATRX,
CDKN2A/B, TERT, 1p/19q, BRAF.
o measures of surgical effectiveness: extent of resection (EOR), volume of residual tumor,
length of hospital stay, 30-day readmission rate, time to recurrence, PFS and OS.