3D Prediction of Patient-Specific Response

Ovarian Cancer Clinical Trial

— 3D-PREDICT  

Official title:

3D-PREDICT REGISTRY: 3D Prediction of Patient-specific Response Using Ex Vivo Interrogation of Live Cells From Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03561207
• Other study ID #: KIY-REG-001
• Status: Active, not recruiting
• Start date: June 11, 2018
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: KIYATEC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 570
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Anaplastic Astrocytoma
• Astrocytoma
• Glioblastoma
• Glioblastoma Multiforme
• Ovarian Cancer

Intervention

Diagnostic Test:
• EV3D Assay
The EV3D assay uses freshly obtained tumor specimen to predict tissue drug response.

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Prisma Health	Greenville	South Carolina
United States	Penn State Health, Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	University of Arkansas for Medical Sciences, Winthrop P. Rockefeller Cancer Institute	Little Rock	Arkansas
United States	Oregon Health & Science University	Portland	Oregon
United States	Veterans Administration Portland Health Care System	Portland	Oregon
United States	University of California, San Francisco	San Francisco	California
United States	Capital Health Institute for Neurosciences	Trenton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
KIYATEC

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 P — View Citation

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 T — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish correlation of Assay results with patient outcomes	Compare Assay results to reported patient outcomes	2 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Define Assay success across histologic subtypes and classes of anti-cancer compounds	Evaluate Assay success rate	2 years

External Links

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