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

• ClinicalTrials.gov Identifier: NCT03561207
• Recruitment Status: Active, not recruiting
• First Posted: June 19, 2018
• Last Update Posted: March 24, 2023
• Sponsor: KIYATEC
• Information provided by (Responsible Party): KIYATEC

Study Description

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.

Condition or disease	Intervention/treatment
Advanced Cancer; Ovarian Cancer; Glioblastoma Multiforme; Anaplastic Astrocytoma	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 Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 570 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 2 Years
• Official Title: 3D-PREDICT REGISTRY: 3D Prediction of Patient-specific Response Using Ex Vivo Interrogation of Live Cells From Tumors
• Actual Study Start Date: June 11, 2018
• Estimated Primary Completion Date: June 2024
• Estimated Study Completion Date: December 2024

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Establish correlation of Assay results with patient outcomes [ Time Frame: 2 year ]
   Compare Assay results to reported patient outcomes

Secondary Outcome Measures :

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

Biospecimen Retention:   Samples With DNA

Fresh tumor tissue

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Locations

United States, Arkansas

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

Little Rock, Arkansas, United States, 72205-7199

United States, California

University of California, San Francisco

San Francisco, California, United States, 94143

United States, New Jersey

Capital Health Institute for Neurosciences

Trenton, New Jersey, United States, 08638

United States, New York

Roswell Park Cancer Institute

Buffalo, New York, United States, 14203

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

Veterans Administration Portland Health Care System

Portland, Oregon, United States, 97239

United States, Pennsylvania

Penn State Health, Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

United States, South Carolina

Prisma Health

Greenville, South Carolina, United States, 29605

United States, Virginia

Inova Fairfax Hospital

Falls Church, Virginia, United States, 22042

Sponsors and Collaborators

KIYATEC

More Information

Additional Information:

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 

Publications of Results:

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.

Other 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.

• Responsible Party: KIYATEC
• ClinicalTrials.gov Identifier: NCT03561207
• Other Study ID Numbers: KIY-REG-001
• First Posted: June 19, 2018
• Last Update Posted: March 24, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Glioblastoma; Astrocytoma; Neoplasms; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue