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Breast cancer study spurs collaboration    by Cindy A. Abole Public Relations For the next five years, David Cole's research with the “Minimally Invasive Molecular Staging of Breast Cancer Trial” or MIMS study, will integrate talents and expertise among the Department of Surgery, Hollings Cancer Center and the Clinical Innovation Group. Established under the MUSC Foundation for Research Development, the Clinical Innovation Group will provide their professional experiences using speed, accuracy and integrity in offering professional design, management and evaluation services for this international study. The MIMS trial evaluates more than 1,100 patients with breast cancer within 12 study-sites around the United States, England and Australia. “The Clinical Innovation Group provides a wonderful resource, thanks to the foresight of the dean and President Edwards,” said Cole, M.D., associate professor, Department of Surgery and the trial's principal investigator. “This project is a significant opportunity to showcase MUSC as a world-class institution for research, using the right resources.” The group helped develop the formal study protocol and will coordinate international patient enrollment. Led by science director Yuko Y. Palesch, Ph.D. and deputy director Marilee Rose, the Clinical Innovation Group will help manage communications and mediate between Cole, study investigators, pathologists, lab staffs and other support personnel at participating sites.  For clinical issues, all queries will be directed to Paul L. Baron, M.D., Department of Surgery, who will act as a medical monitor for all 12 sites. The group will also provide overall leadership in the study's coordination, sample and data gathering. Patient management and all logistical inquiries will be handled by study project manager Terri Putman.  “Our goal is to bring MUSC to the forefront of research and raise its availability as a participant with a solid reputation in large clinical trials,” said Patrick D. Mauldin, Ph.D., the organization's executive director.  As a study site, Hollings Cancer Center and the Department of Surgery will enroll and manage Lowcountry patients throughout the length of the study. The cancer center's Clinical Trials Program, led by Rhonda Hardwick, will collaborate with the Department of Surgery to provide other management support for MUSC's participation. The program will also coordinate surgical procedures for initial lymph node and bone marrow collection. Local study investigators,  Paul H. O'Brien, M.D., Department of Surgery and William E. Gillanders, M.D., an incoming surgical oncologist, will oversee and assist in the patient enrollment efforts. The Hollings Cancer Center's Tumor Bank will serve as the central storage site for all MIMS tissue samples that will undergo analysis. For this effort, Cole, along with co-director Debra J. Hazen-Martin, Ph.D., associate professor of pathology and laboratory medicine will support the tumor bank. Tissue analysis and genetic testing will be also be conducted at Hollings under the direction of Michael Mitas, Ph.D., director of the Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) Laboratory, along with two full-time technicians.  Cole believes that one of the biggest challenges during the trial will be the assurance of uniformity. Since the study focuses on four lymph node tissue specimens, variables such as time, handling, storage and transportation become crucial to each sample review and the trial. Cole underlines the study's emphasis on training and review for participating surgeons, clinicians, pathologists and lab technicians in the trial's handling of specimens and other laboratory protocols. This attention to detail provides good research samples, and will help ensure the effectiveness of good patient care. Initial attempts to address study issues and other procedures were addressed at a formal gathering of MIMS trial investigators, surgeons, pathologists and research coordinators at a meeting held recently in Charleston. Ray Greenberg, M.D., Ph.D., vice president for academic affairs and provost will serve an interactive role in the MIMS study by contributing his expertise as a world-renown epidemiologist. “Working with this trial allows MUSC and the Clinical Innovation Group to showcase their relationships by working and collaborating with scientists and other high quality contacts within a professional multi-site trial,” said Ken J. Roozen, Ph.D., executive director for MUSC's Foundation for Research Development. “Overall, it presents a positive, productive, high-energy profile of MUSC to companies we can do business with.” Founded in 1998, the Clinical Innovation Group joins the ranks of an elite group of internationally-recognized academic research players like Duke and the University of Rochester.  The organization currently manages several multi-site trial projects which support MUSC research. Some examples of current trials include the Stent Radiation Therapy Intervention for Esophageal Cancer Dysphagia (SORTIE), clinical director Peter Cotton, M.D., FRCP; Geriatric Psychiatry Program director Jacobo Mintzer's research on Alzheimer's disease within a family practice setting; and the Tracheobronchial Stent Study of patients with lung cancer directed by Gerard A. Silvestri, M.D., associate professor of medicine.