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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tumor tissue tested with EV3D Assay | Cancer tissue from multiple sites in the body, to include ovarian, brain, and other rare tumors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV3D Assay | Diagnostic Test | The EV3D assay uses freshly obtained tumor specimen to predict tissue drug response. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Establish correlation of Assay results with patient outcomes | Compare Assay results to reported patient outcomes | 2 year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences, Winthrop P. Rockefeller Cancer Institute | Little Rock | Arkansas | 72205-7199 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31371750 | Background | 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. | |
| 34142085 |
| Label | URL |
|---|---|
| Prospective Validation of an Ex Vivo, Patient-Derived 3D Spheroid Model for Response Predictions in Newly Diagnosed Ovarian Cancer | View source |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005909 | Glioblastoma |
| D001254 | Astrocytoma |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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Fresh tumor tissue
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 |
| University of California, San Francisco |
| San Francisco |
| California |
| 94143 |
| United States |
| Capital Health Institute for Neurosciences | Trenton | New Jersey | 08638 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14203 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Veterans Administration Portland Health Care System | Portland | Oregon | 97239 | United States |
| Penn State Health, Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Prisma Health | Greenville | South Carolina | 29605 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| Result |
| 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. |
| 34943910 | Result | 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. |
| Prospective prediction of clinical drug response in high-grade gliomas using an ex vivo 3D cell culture assay | View source |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |