The Protocol Support Laboratory (PSL) was formed in 1999 to centralize the management of the collection, documentation, processing, storage and shipping of patient samples collected as outlined in the context of clinical trials and research studies in medical oncology surgery, basic science, prevention and radiation. The PSL works closely with the clinical trial operations. The Protocol Support Laboratory is directed by R. Katherine Alpaugh, a PhD-level investigator who has forty-five years in clinical laboratory science and has an adjunct professorship at Lehigh University in Bethlehem, PA. The laboratory staff includes seven American Society for Clinical Pathology-certified technicians/technologists. This established resource provides an efficient mechanism for the uniform handling of laboratory specimens, together with the capability to perform some selected detailed immunologic assays. The PSL works closely with pathology departments both at FCCC and outside the center to acquire the needed tissue specimens required for eligibility testing for the clinical trials incorporating specific targeting agents. The number of specimens handled has continued to increase through 2014 to more than 10,000 specimens yearly.
In addition, Dr. Alpaugh’s main research interest has been circulating tumor cells for more than fifteen years. The laboratory has CLIA certification to perform the clinical enumeration of circulating tumor cells and has served as a reference laboratory for selected clinical trials in this capacity. Leadership from the lab attend site initiation visits, and provide clarification for questions related to pharmacokinetic and pharmacodynamic sample procurement and associated processes. The PSL is also actively involved in the feasibility committee review process.