Spots Global Cancer Trial Database for 3D Prediction of Patient-Specific Response
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Trial Identification
Brief Title: 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 ID: NCT03561207
Interventions
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.
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).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arkansas for Medical Sciences, Winthrop P. Rockefeller Cancer Institute, Little Rock, Arkansas, United States
University of California, San Francisco, San Francisco, California, United States
Capital Health Institute for Neurosciences, Trenton, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Oregon Health & Science University, Portland, Oregon, United States
Veterans Administration Portland Health Care System, Portland, Oregon, United States
Penn State Health, Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Prisma Health, Greenville, South Carolina, United States
Inova Fairfax Hospital, Falls Church, Virginia, United States
Contact Details
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