3D-Prediction of Patient-Specific Response



Status:Enrolling by invitation
Healthy:No
Age Range:18 - Any
Updated:2/3/2019
Start Date:June 11, 2018
End Date:June 2022

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3D-PREDICT REGISTRY: 3D Prediction of Patient-specific Response Using Ex Vivo Interrogation of Live Cells From Tumors

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.

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 will have access to Assay results which is predicting tissue response to
standard of care agents. The Assay currently assesses the most common standard of care agents
across multiple tumor types and 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) including Anaplastic Astrocytoma (AA) and Glioblastoma multiforme (GBM),
and high grade rare tumors (RT).

Inclusion Criteria:

- Patient 18 years and older

- Any patient with a diagnosis of or a suspected diagnosis of advanced cancer (ovarian,
brain or other rare tumors) undergoing surgery or biopsy to remove tumor tissue

- Must be considered a candidate for systemic therapy with cytotoxic chemotherapy,
targeted small molecule inhibitors or immunotherapy

- Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

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

Exclusion Criteria:

- Patient refusing or unable to sign informed consent

- Patient who fails to have surgery or a biopsy as part of routine clinical practice

- Patient who refuses 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 stable.

- Patients unable or unwilling to receive 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
We found this trial at
4
sites
665 Elm Street
Buffalo, New York 14263
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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GHS
Greenville, South Carolina 29605
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Greenville, SC
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Portland, Oregon 97201
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Portland, OR
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