Abstract 4821: Circulating tumor cells: A key deliverable in oncology clinical trials

Circulating tumor cell (CTC) enumeration is a new pharmacodynamic biomarker developed from an emerging rare event technology showing prognostic potential for the management and monitoring of patients with colon, breast, and prostate cancer. As more evidence is gradually accumulating at multiple cancer institutes, CTC has the potential to become a surrogate marker for cancer prognosis. There are challenges in performing CTC testing, however this assay has the opportunity to become a key deliverable in oncology clinical trials. Our experience in the implementation of CTC testing in clinical trials over the past four years has led to recommendations for future CTC applications, including critical aspects such as sample accessioning and logistics, operational maintenance and method training, data collection and sufficient IT infrastructure to accommodate large data files in full scale trial operations. To have a successful trial using the CTC test as a monitored biomarker, the estimation of sample size for the clinical trial has to take into consideration the anticipated disqualification rate of collected samples. In our clinical trial experiences, 10% of samples submitted were disqualified for reasons ranging from insufficient sample volume to severe hemolysis. Sample logistics and transportation considerations are keys to successful sample management. Strict quality control (QC) measurements, a robust training program, effective data management, and proper maintenance of the CTC system are keys for delivering standardized results in a timely manner. Our results indicate that CTC testing can be effectively incorporated into large scale clinical trials and the data can be seamlessly integrated into the Laboratory Information Management System (LIMS). CTC results may offer clinically useful information about patients and their response to therapy. From a patient perspective, the CTC test only requires a tube of blood and is well suited to multiple sampling time points during a clinical trial. Citation Format: Chengsen Xue, Kasia E. Cortes, Dorina Hura, Melissa L. Baptiste, Paradiso Renato, Joanne Cuomo, Thomas W. Mc Closkey. Circulating tumor cells: A key deliverable in oncology clinical trials. [abstract]. In: Proceedings of the 105th Annual Meeting of the American Association for Cancer Research; 2014 Apr 5-9; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2014;74(19 Suppl):Abstract nr 4821. doi:10.1158/1538-7445.AM2014-4821