3D Prediction of Patient-Specific Response
3D Prediction of Patient-Specific Response
This is a prospective, non-randomized, observational registry study evaluating a
 patient-specific ex vivo 3D (EV3D) assay for drug response using a patient's own biopsy or
 resected tumor tissue for assessing tissue response to therapy in patients with advanced
 cancers, including ovarian cancer, high-grade gliomas, and high-grade rare tumors.
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).
Inclusion Criteria:

 -  Age 18 years and older

 -  Diagnosis of or suspected diagnosis of EOC, HGG, high-grade RT

 -  Individual must undergo elective surgery or biopsy to remove tumor tissue

 -  Consideration as a candidate for systemic therapy with cytotoxic chemotherapy,
 targeted small molecule inhibitors or immunotherapy

 -  Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 3

 -  Written informed consent in accordance with institutional standards must be obtained
 from the patient or legal guardian

 Exclusion Criteria:

 -  Inability or refusal of the patient or legal guardian to sign a written informed
 consent

 -  Failure to have surgery or a biopsy as part of routine clinical practice

 -  Refusal to have the Assay performed on their tissue

 -  Known active cancer metastatic to the brain except for patients with brain metastases
 that have been treated and are considered stable.

 -  Inability or unwillingness to receive chemotherapy treatment beyond surgery

 -  Any coincidental medical condition that, in the Investigator's opinion, would preclude
 participation in the study or compromise the patient's ability to give informed
 consent