3D Prediction of Patient-Specific Response (3D-PREDICT)

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, including ovarian cancer, high-grade gliomas, and high-grade rare tumors.

Study Overview

• Status: Active, not recruiting
• Conditions: Ovarian Cancer; Glioblastoma Multiforme; Anaplastic Astrocytoma; Advanced Cancer
• Intervention / Treatment: Diagnostic test: EV3D Assay

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).

• Study Type: Observational
• Enrollment (Anticipated): 570

Contacts and Locations

• Study Contact: Name: Cecile Rose T. Vibat, PhD; Phone Number: 864-502-2013; Email: cecilerose.vibat@kiyatec.com

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205-7199
      • University of Arkansas for Medical Sciences, Winthrop P. Rockefeller Cancer Institute
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • New Jersey
    • Trenton, New Jersey, United States, 08638
      • Capital Health Institute for Neurosciences
  • New York
    • Buffalo, New York, United States, 14203
      • Roswell Park Cancer Institute
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
    • Portland, Oregon, United States, 97239
      • Veterans Administration Portland Health Care System
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Health, Milton S. Hershey Medical Center
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Prisma Health
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with suspected, newly diagnosed or relapsed diagnosis of advanced cancer (ovarian, brain, or other rare tumors) undergoing surgery or biopsy to remove tumor tissue will be enrolled and their tissue collected and tested with the EV3D Assay across drugs that are most often used to treat the specified cancer types, including standard of care therapies or as recommended by NCCN guidelines.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish correlation of Assay results with patient outcomes	Compare Assay results to reported patient outcomes	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the use of Assay results and the effects on medical decision-making and patient outcomes	Determine potential effect of Assay results on treatment plan	2 year
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	Compare Assay results to study patient clinical response	2 years
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	Compare Assay results to historical clinical response rates	2 years
Compare clinical outcomes (event free survival and overall survival) in patients who are treated aligned with Assay results versus historical response rates	Compare survival of study patients aligned with Assay results to historical survival rates	2 years
Define Assay success across histologic subtypes and classes of anti-cancer compounds	Evaluate Assay success rate	2 years

Collaborators and Investigators

• Sponsor: KIYATEC
• Investigators: Study Director: Cecile Rose T. Vibat, PhD, KIYATEC

Publications and helpful links

General Publications

• Shuford S, Wilhelm C, Rayner M, Elrod A, Millard M, Mattingly C, Lotstein A, Smith AM, Guo QJ, O'Donnell L, Elder J, Puls L, Weroha SJ, Hou X, Zanfagnin V, Nick A, Stany MP, Maxwell GL, Conrads T, Sood AK, Orr D, Holmes LM, Gevaert M, Crosswell HE, DesRochers TM. Prospective Validation of an Ex Vivo, Patient-Derived 3D Spheroid Model for Response Predictions in Newly Diagnosed Ovarian Cancer. Sci Rep. 2019 Aug 1;9(1):11153. doi: 10.1038/s41598-019-47578-7.
• Shuford S, Lipinski L, Abad A, Smith AM, Rayner M, O'Donnell L, Stuart J, Mechtler LL, Fabiano AJ, Edenfield J, Kanos C, Gardner S, Hodge P, Lynn M, Butowski NA, Han SJ, Redjal N, Crosswell HE, Vibat CRT, Holmes L, Gevaert M, Fenstermaker RA, DesRochers TM. Prospective prediction of clinical drug response in high-grade gliomas using an ex vivo 3D cell culture assay. Neurooncol Adv. 2021 May 7;3(1):vdab065. doi: 10.1093/noajnl/vdab065. eCollection 2021 Jan-Dec.
• Reed MR, Lyle AG, De Loose A, Maddukuri L, Learned K, Beale HC, Kephart ET, Cheney A, van den Bout A, Lee MP, Hundley KN, Smith AM, DesRochers TM, Vibat CRT, Gokden M, Salama S, Wardell CP, Eoff RL, Vaske OM, Rodriguez A. A Functional Precision Medicine Pipeline Combines Comparative Transcriptomics and Tumor Organoid Modeling to Identify Bespoke Treatment Strategies for Glioblastoma. Cells. 2021 Dec 2;10(12):3400. doi: 10.3390/cells10123400.

Helpful Links

• Prospective Validation of an Ex Vivo, Patient-Derived 3D Spheroid Model for Response Predictions in Newly Diagnosed Ovarian Cancer
• Prospective prediction of clinical drug response in high-grade gliomas using an ex vivo 3D cell culture assay
• A Functional Precision Medicine Pipeline Combines Comparative Transcriptomics and Tumor Organoid Modeling to Identify Bespoke Treatment Strategies for Glioblastoma

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2018
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: June 10, 2018
• First Submitted That Met QC Criteria: June 10, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Astrocytoma
• Other Study ID Numbers: KIY-REG-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No