In 1999, TRIO became one of the first groups to successfully establish a pre-randomization tumour tissue acquisition and central laboratory process whereby patients’ tumour tissues are collected and evaluated centrally for a specific biomarker prior to entry into a clinical trial. Performed by TRIO’s molecular pathologist, Dr. Michael Press from the University of Southern California in Los Angeles, California, these first studies included the central evaluation of over 12,000 breast cancer samples for HER2 through FISH testing. The average turnaround time for all of this was 2.2 days from receipt to result to the investigator.
All TRIO studies require tumour tissue—either paraffin or frozen—and blood samples from patients for the purpose of protocol-specified translational research. Patients may also allow TRIO to keep their samples for future noncommercial research purposes.
Together with Dr. Press, Dr. Slamon and its partners, TRIO continues to excel in the collection and maintenance of its tissue acquisition process. Through TRIO’s translational process, many hypotheses have been generated and confirmed, and our knowledge and understanding of the molecular basis of cancer has grown.