Clinical Trials
Biocytics™ is currently enrolling participants for trial #0001, which was approved by the Western Institutional Review Board.
| Biocytics™ #0001: A Pilot Study to Facilitate Development of an Ex-Vivo Device Kit for Circulating Tumor Cell Harvesting, Banking, and Apoptosis-Viability Assay |
Study Design
This is a “device” protocol to collect data for future device submission for “device approval” by the FDA. There may be other applications that are discovered with the use of this device and storage of tumor cells.
Primary Objective
This is a pilot study to investigate the feasibility of harvesting, expanding in culture, and freezing circulating tumor cells from cancer patients.
Secondary Objectives
- Develop methodology and proprietary techniques towards using viable circulating tumor cells for tumor apoptosis-viability assay (TAVA) after exposure to chemotherapy and targeted drugs ex-vivo.
- Upon validation of Biocytics™ circulating tumor cell TAVA, a FDA Pre-market Notification 510(k) application for in-vitro device kit will be submitted.
- Preliminary assessment of bioinformatics, cell processing, genomic, and cryogenic infrastructure needed to create a bio-repository for tumor cells.
- Preliminary assessment of proprietary software interfaces to create a de-identified clinical database linked to a genomic tumor database for future personalized targeted medicines and adaptive trial design.
- Banking of plasma, tumor cells, and non-tumor cells from peripheral blood for facilitation of biomarker discovery
