3D-Prediction of Patient-Specific Response

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Status: Enrolling by Invitation

Description

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 and Glioblastoma multiforme.

Eligibility Criteria

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

Locations & Contacts

California

San Francisco
UCSF Medical Center-Mount Zion
Status: Active
Contact: Helen Diller Family Comprehensive Cancer Center
Phone: 877-827-3222
Email: cancertrials@ucsf.edu

Trial Objectives and Outline

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).

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Not provided by clinicaltrials.gov

Lead Organization

Lead Organization
Kiyatec

Trial IDs

Primary ID KIY-REG-001
Secondary IDs NCI-2019-05887
Clinicaltrials.gov ID NCT03561207