Core--Clinical Investigations Core

University Of Colorado Denver, Aurora CO

Investigators

Linked publications & trials

Abstract

Our increased understanding of the molecular basis of lung cancer has created a need to conduct studies that involve the collection of both clinical data and specimens for molecular analyses. This translational approach will allow us to investigate biological pathways of carcinogenesis from human tissue and be a powerful tool to guide us in evaluating novel, biologically rationale strategies for the prevention, screening and early detection of lung cancer as wcll as new targeted therapies for lung cancer. Thus the primary goals of the tissue procurement and clinical trials core are to encourage interactions between basic and clinical researchers to generate pivotal translational research clinical trials and to provide the necessary infrastructure to execute these trials. Specifically we offer expertise in clinical trial methodology, protocol writing, regulatory documentation and quality assurance measures. In addition we provide clinical research associates to accrue subjects and collect data and tissue samples for all SPORE-initiated trials. All data is entered into a web database that is designed to link the clinical information to the biological correlative studies for future analyses. Over the past five years there have been 20 clinical trials supported by the core. Six trials are actively accruing subjects. A new chemoprevention trial evaluating the activity of Iloprost, a prostacyclin synthase was activated in May 2002. The success of the core has lead to multiple publications. For example over the last grant year, 17 manuscripts have been published or are in press. Several manuscripts have been published describing our positive experience with fluorescent bronchoscopy to detect preneoplastic lesions, while basic researchers have reported on biomarker examination of bronchial specimens for p53, bcl-2, EGFR, Her 2/neu and E-cadherin to gain a better understanding of their role in apoptosis, cell signaling, and cell adhesion in the carcinogenesis process (SPORE trial #3, #15 and #24). A paper demonstrating the feasibility of randomizing patients to low dose spiral CT or observation is in press (SPORE trial #23). In preparation are manuscripts correlating bronchial dysplasia to patient characteristics (SPORE trials #2, #4, #6, #15, #16, and #24) and a manuscript evaluating histological response models for chemoprevention trials (SPORE trial #6).