Protocol Support Laboratory

Katherine Alpaugh, PhD
Assistant Research Professor
[email protected]
Hospital CRU Second Floor



The centralized collection, processing, analysis, shipping and tracking of clinical research specimens is integrated with clinical trial operations though the Protocol Support Lab (PSL). The laboratory staff includes American Society for Clinical Pathology-certified technicians and 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. Working with Pathology, eligibility testing now occurs within three days. The number of specimens handled has continued to increase to more than 10,000 specimens in 2014.

In addition, the laboratory has the capacity to conduct Circulating Tumor and Endothelial Cell Assays, under CLIA certification. The PSL has served as a reference laboratory for selected clinical trials. The lab, which is a unique resource to support clinical research, coordinates the collection, processing and shipping of clinical research biomarker samples. Leadership from the PSL attend site initiation visits, and provide clarification for questions related to biomarker sample procurement and associated processes. The lab is also actively involved in the Feasibility Committee Review process.


The Protocol Support Laboratory and the Biosample Repository work closely together to optimize the utilization of patient specimens. Collaborative associations between pharmaceutical companies and/or biotechnical companies have been established to investigate new technologies and the feasibility of incorporating these technologies into clinical trial correlative testing. Correlative studies to enumerate and phenotype both circulating tumor cells and circulating endothelial cells are two of the collaborative associations. These studies have been incorporated into co-operative group trials and in-house investigator-initiated trials.