3D Prediction of Patient-Specific Response

This protocol defines a prospective, open-label, multi-institutional, non-interventional

study for the purpose of examining the Assay's clinical use and potential to impact

patient outcomes. This Study will establish a registry of clinical parameters, including

clinical response, clinical outcomes, Assay performance and potential utilization across

multiple types of advanced cancers in consenting patients who have their tumor tissue

tested by the Assay. Physicians may have access to Assay results which which predict

therapeutic response to cancer drugs most often prescribed to treat the specified

indications. For cancers with standard of care (SOC) cancer drug treatments, the Assay

panel tests SOC systemic agents per NCCN guidelines, some of which may include both FDA

approved and off-label FDA approved therapies. The Assay currently assesses the most

common cancer drugs across multiple tumor types. It requires freshly obtained tumor

specimen that has not been previously preserved for traditional histologic analysis. The

Registry will focus initially on tumor types and agents which have been analytically

validated with the Assay and determined to meet strict laboratory qualifications and

standards. The Registry will collect data on a limited number of cancer types to include

epithelial ovarian cancer (EOC), high-grade gliomas (HGG) limited to anaplastic

astrocytoma (AA) and glioblastoma multiforme (GBM), and high-grade rare tumors (RT).