3D Prediction of Patient-Specific Response
- Conditions
- Ovarian CancerAnaplastic AstrocytomaAdvanced CancerGlioblastoma Multiforme
- Interventions
- Diagnostic Test: EV3D Assay
- Registration Number
- NCT03561207
- Lead Sponsor
- KIYATEC
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 570
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Tumor tissue tested with EV3D Assay EV3D Assay Cancer tissue from multiple sites in the body, to include ovarian, brain, and other rare tumors.
- Primary Outcome Measures
Name Time Method Establish correlation of Assay results with patient outcomes 2 year Compare Assay results to reported patient outcomes
- Secondary Outcome Measures
Name Time Method Compare clinical response (progression free survival or time to progression) in patients who receive treatment aligned with Assay results of response versus patients who are not treated aligned with Assay results of response 2 years Compare Assay results to study patient clinical response
Define Assay success across histologic subtypes and classes of anti-cancer compounds 2 years Evaluate Assay success rate
Evaluate the use of Assay results and the effects on medical decision-making and patient outcomes 2 year Determine potential effect of Assay results on treatment plan
Compare clinical outcomes (event free survival and overall survival) in patients who are treated aligned with Assay results versus historical response rates 2 years Compare survival of study patients aligned with Assay results to historical survival rates
Compare clinical response (progression free survival or time to progression) in patients who receive treatment aligned with Assay results of response versus historical response rates 2 years Compare Assay results to historical clinical response rates
Trial Locations
- Locations (9)
Penn State Health, Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
University of Arkansas for Medical Sciences, Winthrop P. Rockefeller Cancer Institute
🇺🇸Little Rock, Arkansas, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Capital Health Institute for Neurosciences
🇺🇸Trenton, New Jersey, United States
Prisma Health
🇺🇸Greenville, South Carolina, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Veterans Administration Portland Health Care System
🇺🇸Portland, Oregon, United States