Clinical trial NCT03561207: 3D Prediction of Patient-Specific Response
Official title: 3D-PREDICT REGISTRY: 3D Prediction of Patient-specific Response Using Ex Vivo Interrogation of Live Cells From Tumors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Cancer
Ovarian Cancer
Glioblastoma Multiforme
Anaplastic Astrocytoma
Lead sponsor: KIYATEC
Sponsor class: INDUSTRY
First posted: 2018-06-19
Enrollment: 570
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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).

Eligibility 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

Primary outcomes:
measure: Establish correlation of Assay results with patient outcomes
timeFrame: 2 year
Secondary outcomes:
measure: Evaluate the use of Assay results and the effects on medical decision-making and patient outcomes
timeFrame: 2 year
measure: 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
timeFrame: 2 years
measure: 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
timeFrame: 2 years
measure: Compare clinical outcomes (event free survival and overall survival) in patients who are treated aligned with Assay results versus historical response rates
timeFrame: 2 years
measure: Define Assay success across histologic subtypes and classes of anti-cancer compounds
timeFrame: 2 years
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences, Winthrop P. Rockefeller Cancer Institute
state: Arkansas
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Trenton
country: United States
facility: Capital Health Institute for Neurosciences
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Portland
country: United States
facility: Veterans Administration Portland Health Care System
state: Oregon
city: Hershey
country: United States
facility: Penn State Health, Milton S. Hershey Medical Center
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
Study officials:
References:
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.
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 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.
citation: 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.