3D Prediction of Patient-Specific Response

Status: closed to accrual

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.

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

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).

Have a question?
We're here to help

Chat with us: LiveHelp
Call us: 1-800-4-CANCER
(1-800-422-6237)

Which trials are right for you?

Use the checklist in our guide to gather the information you’ll need.

3D Prediction of Patient-Specific Response

Description

Eligibility Criteria

Locations & Contacts

Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

Have a question?We're here to help

Which trials are right for you?

Have a question?
We're here to help