NCT03561207

3D Prediction of Patient-Specific Response

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 570 (estimated)
• Sponsor: KIYATEC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	EV3D Assay	The EV3D assay uses freshly obtained tumor specimen to predict tissue drug response.

Timeline

• Start date: 2018-06-11
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2018-06-19
• Last updated: 2023-03-24

Locations

9 sites across 1 country: United States