Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Tumor tissue tested with EV3D Assay Cancer tissue from multiple sites in the body, to include ovarian, brain, and other rare tumors.
  • Diagnostic Test: EV3D Assay
    The EV3D assay uses freshly obtained tumor specimen to predict tissue drug response.

Recruiting Locations

University of Arkansas for Medical Sciences, Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas 72205-7199
Contact:
Michael Birrer, MD, PhD

University of California, San Francisco
San Francisco, California 94143
Contact:
Nicolas A Butowski, MD

Capital Health Institute for Neurosciences
Trenton, New Jersey 08638
Contact:
Navid Redjal, MD, FAANS

Roswell Park Cancer Institute
Buffalo, New York 14203
Contact:
Adekunle Odunsi, MD, PhD

Oregon Health & Science University
Portland, Oregon 97239
Contact:
Koenraad De Geest, MD

Veterans Administration Portland Health Care System
Portland, Oregon 97239
Contact:
Seunggu J Han, MD

Penn State Health, Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
Contact:
Seyed A Mansouri, MD

Prisma Health
Greenville, South Carolina 29605
Contact:
William J Edenfield, MD

Inova Fairfax Hospital
Falls Church, Virginia 22042
Contact:
George L Maxwell, MD

More Details

NCT ID
NCT03561207
Status
Recruiting
Sponsor
KIYATEC

Study Contact

Cecile Rose T Vibat, PhD
864-502-2013
cecilerose.vibat@kiyatec.com

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.