3D Prediction of Patient-Specific Response

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03561207
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

KIYATEC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Cecile Rose T. Vibat, PhD
Principal Investigator Affiliation KIYATEC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Advanced Cancer, Ovarian Cancer, Glioblastoma Multiforme, Anaplastic Astrocytoma
Study Website: View Trial Website
Additional Details

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).

Arms & Interventions

Arms

: Tumor tissue tested with EV3D Assay

Cancer tissue from multiple sites in the body, to include ovarian, brain, and other rare tumors.

Interventions

Diagnostic Test: - EV3D Assay

The EV3D assay uses freshly obtained tumor specimen to predict tissue drug response.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Little Rock, Arkansas

Status

Recruiting

Address

University of Arkansas for Medical Sciences, Winthrop P. Rockefeller Cancer Institute

Little Rock, Arkansas, 72205-7199

Site Contact

Michael Birrer, MD, PhD

cecilerose.vibat@kiyatec.com

864-502-2013

University of California, San Francisco, San Francisco, California

Status

Recruiting

Address

University of California, San Francisco

San Francisco, California, 94143

Site Contact

Nicolas A. Butowski, MD

cecilerose.vibat@kiyatec.com

864-502-2013

Trenton, New Jersey

Status

Recruiting

Address

Capital Health Institute for Neurosciences

Trenton, New Jersey, 08638

Site Contact

Navid Redjal, MD, FAANS

cecilerose.vibat@kiyatec.com

864-502-2013

Roswell Park Cancer Institute, Buffalo, New York

Status

Recruiting

Address

Roswell Park Cancer Institute

Buffalo, New York, 14203

Site Contact

Lindsay Lipinski, MD

cecilerose.vibat@kiyatec.com

864-502-2013

Oregon Health & Science University, Portland, Oregon

Status

Recruiting

Address

Oregon Health & Science University

Portland, Oregon, 97239

Site Contact

Jesse Liu, MD

cecilerose.vibat@kiyatec.com

864-502-2013

Portland, Oregon

Status

Recruiting

Address

Veterans Administration Portland Health Care System

Portland, Oregon, 97239

Site Contact

Jesse Liu, MD

cecilerose.vibat@kiyatec.com

864-502-2013

Hershey, Pennsylvania

Status

Recruiting

Address

Penn State Health, Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033

Site Contact

Seyed A. Mansouri, MD

cecilerose.vibat@kiyatec.com

864-502-2013

Prisma Health, Greenville, South Carolina

Status

Recruiting

Address

Prisma Health

Greenville, South Carolina, 29605

Site Contact

William J. Edenfield, MD

cecilerose.vibat@kiyatec.com

864-502-2013

Inova Fairfax Hospital, Falls Church, Virginia

Status

Recruiting

Address

Inova Fairfax Hospital

Falls Church, Virginia, 22042

Site Contact

George L. Maxwell, MD

cecilerose.vibat@kiyatec.com

864-502-2013

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