Administration and Communication Core
Principal Investigator(s): Richard F. Ambinder, M.D., Ph.D.
This core will be responsible for managing the SPORE and disseminating information within the SPORE and for external interactions. The Core is designed for low-cost, yet efficient administration and communication in order to focus funds on research activities. The administrative component of the Core follows an organizational diagram for management activities. Monitoring of research will occur via 1) Research Project Teams, 2) Committee of Research Project Principal Investigators, 3) Core Investigators Committee, 4) Developmental Projects Program, 5) Career Development Committee, and 6) the central SPORE Steering Committee. An institutional Advisory Board and External Advisory Board will provide yearly formal evaluations and reports to the Steering Committee.
The communication component of the Core is directed at intra-SPORE, inter-SPORE, and National Cancer Institute research activities. The Core provides travel funds for Johns Hopkins Lymphoma SPORE participation in the NCI SPORE annual meetings, to include the SPORE Director/PI, members of the Committee of Research Project Principal Investigators and other SPORE investigators. In addition, communication of validated results to the medical community in order to impact on the incidence and mortality of colorectal and pancreatic cancer will occur via publication of SPORE findings in medical journals, occasional inter-institutional think tanks and organized public conferences through the Office of Continuing Medical Education of the Johns Hopkins Medical Institutions, news releases to medical writers and press conferences for announcement of vital advances through the Office of Public Affairs of The Johns Hopkins Medical Institutions, and when appropriate, alerts coordinated through the NCI program staff.
Human Specimen Resource and "Laboratory Core"
Principal Investigator(s): Michael Borowitz, M.D., Ph.D.; Hyam Levitsky, M.D. Co-Investigator(s): Richard Schulick, M.D.; Janice Davis-Sproul, Ph.D; Edward Weir, M.D.; Risa Mann, M.D.
The Laboratory core is an interdepartmental collaborative effort designed to support basic and translational research on the etiology, early detection, prevention, and treatment of lymphoma. The Core provides a human specimen resource of neoplastic and normal tissue from patients with lymphoma with quality assurance measures, inventory and tracking, and correlative clinical data. This data will be stored in a secure relational database with web interface and both tape back -up of data and back-up server. In addition, the laboratory core will support the certification and preparation of clinical lots of genetically altered cell lines to be used as vaccines in lymphoma-related clinical trials. Storage of frozen specimens, laboratory processing, and data management will take place in the newly constructed Weinberg building of the Johns Hopkins cancer Center in immediate proximity to the operating rooms and surgical pathology laboratory in close collaboration with the breast and gastrointestinal SPOREs tissue banking efforts. The Core is directed by an experienced hematopathologist with prior tissue banking experience. The Co-PI is an experienced translational immunologist who will oversee production of the vaccines and immunologic assays performed on patient materials supported through this core.
Principal Investigator(s): Ian Flinn, M.D., Ph.D. Co-Investigator(s): Richard Jones, M.D.
The Clinical Trials Core is a multidisciplinary effort designed to support the translational research of this SPORE. This resource will provide assistance in the design, conduct, and analysis of the clinical trials conducted within the spore. Specifically, assistance with translating laboratory findings into questions answerable within a clinical trial, clinical trial development, regulatory assistance with IND and IRB approvals, and clinical trial conduct will be provided. The core will provide research nursing, data management, adverse event reporting, and trial monitoring for the clinical trials. The core will assure the safety and confidentiality of the data within a pre-existing relational database with web interface. This core will support the laboratory core by managing the human investigation issues including obtaining informed consent from patients for the human tissue repository. The Core is directed by an experienced lymphoma clinical investigator with prior experience in database design. The Core Co-investigator is an experienced laboratory and clinical investigator experienced at moving laboratory findings into the clinic. Staff include Society of Clinical Research Associates certified data managers and experienced research nurses.
Principal Investigator(s): Steven Piantadosi, M.D., Ph.D. Co-Investigator(s): Elizabeth Garrett, Ph.D.; Lisa Jacobson, Ph.D.
The Biostatistics Core of the proposed Johns Hopkins SPORE in lymphoma is designed to:
1. Provide biostatistical consultation and support to all projects in the program, by assisting in the design, collection, visualization, analysis, quantitative modeling, interpretation and publication of the data arising in the course of program activities.
2. Provide consultation for the design and analysis of clinical trials and other cohort studies to all the projects in the program by working with the Clinical Trials Core.
3. Provide the infrastructural support, programming, and computer maintenance necessary to biostatistical activities within the program.
The Core will have an integral role in the scientific development, execution, and analysis of all projects in the SPORE, including the clinical trials. Core investigators have extensive and complementary experiences in quantitative methods for biomedical applications, including both clinical and basic science studies. They are committed to taking a direct interest in the substantive issues being investigated; to participating in regular project and program meetings, and to providing rigorous and innovative input on all quantitative matters arising in the projects. By contributing to multiple projects, they will also be in a position to promote interdisciplinary interactions among projects.