The purpose of the Administrative Core is to coordinate the activities of the Projects and Cores and to provide oversight and leadership of the scientific, administrative, and fiscal aspects of the MSK Lymphoma SPORE. The Core will oversee the coordination of the various clinical and translational studies outlined, and will integrate scientific and clinical efforts within and between Projects and Cores, and assure the timely enrollment of patients on clinical trials and performance of the translational studies. The Core will provide support to ensure seamless communication and exchange of data between Projects and Cores. This Core will facilitate exchange of information among the all investigators, as well as the Internal and External Advisory Board members. It will ensure compliance with institutional policies to protect human subjects, and will encourage participation of women and minorities on the proposed clinical trials. The Core will oversee all financial expenditures, and will ensure compliance with institutional and regulatory agencies. The work of the Core is organized into three Aims:
Aim 1. To coordinate all meetings to evaluate and monitor the SPORE scientific activities
Aim 2. To coordinate communications among Projects, Cores, and internal and external programs
Aim 3. To provide administrative and financial support for the Projects and Cores
Core 1: Biospecimens
Ahmet Dogan, MD, PhD
The purpose of the Memorial Sloan Kettering Cancer Center (MSK) Lymphoma SPORE is to support the proposed research aim of improving the cure rate of patients with DLBCL. The main role of the Biospecimen Core is to collect, characterize, annotate, bank and distribute biospecimens including primary tumor tissue and cells, bone marrow, peripheral blood white cells, serum and plasma in support of SPORE projects. The core is led by two senior MSK hematopathologists with vast experience in clinical diagnostic and translational research, and biospecimen processing. The core will administer all biospecimen related activities primarily using existing state-of-the-art institutional infrastructure, biospecimen banking processes, CLIA-based laboratories, and research core facilities. There is an established strong collaborative network among investigators of the MSK lymphoma research group and participating institutions, with the ability to share data and biospecimens across institutions, as evident by joint publications in high profile journals. The Biospecimen Core will be based at MSK, and will provide services and support to SPORE investigators in the three participating institutions. The Biospecimen core will provide the Lymphoma SPORE program with tissue, blood, nucleic acid, and proteomic derivatives essential to achieving the aims of the 4 proposed projects focusing on DLBCL. This shared resource for SPORE investigators will allow for expanding correlative studies, interrogating gene networks, specific signaling pathways, and serve as a hypothesis-generating tool. The following specific aims are proposed:
Aim 1. To collect, process, bank, and distribute biospecimens from patients with DLBCL to SPORE investigators and collaborators in support of their research projects.
Aim 2. To provide comprehensive diagnostic characterization of lymphoma specimens collected from patients enrolled on SPORE clinical trials.
Aim 3. To process and perform integral and integrated biomarker analysis on biospecimens collected from patients enrolled on SPORE clinical trials.
Core 2: Biostatistics and Bioinformatics
Venkatramen Seshan, PhD
The role of the Biostatistics and Bioinformatics Core is to support the investigators of the SPORE in Lymphoma in their research efforts, including laboratory experiments, molecular studies and the design and analysis of clinical trials. In laboratory experiments, core members will assist in the formulation of the experimental design and in the analysis and interpretation of the data at the conclusion of the study. In molecular studies, core members will closely interface with the members of the Biospecimen Core, and will have primary responsibility of merging molecular and clinical data, followed by appropriate statistical analysis and reporting. In the clinical trial design phase, a core member will conduct a protocol review with the principal investigator. Based on this, a statistical section for the protocol will be provided, outlining major scientific objectives, population to be studied, primary and secondary endpoints, experimental design, a randomization procedure if necessary, analysis plans, and a targeted sample size justified in probabilistic terms. At the conclusion of the trial, data analyses will be performed to assess outcomes of the primary and secondary endpoints stated in the protocol. If current statistical methodology does not adequately address a research question in this SPORE, alternative methodologies will be explored. The Biostatistics Core assists the research efforts of the investigators of the MSKCC SPORE in Lymphoma, contributing to the design and analysis of clinical and laboratory research and the development of valid conclusions. The core provides statistical analysis and consultancy as well as ongoing quality assurance. The core has also established a data quality working group to improve the quality of data that will be generated by the SPORE projects. The analytical methods necessary to search for new markers, investigate patterns of gene expression, predict patient outcomes, and assess therapeutic trial results are becoming increasingly complex. Many analyses cannot be done by the basic scientists or clinicians themselves, and dedicated methodological collaborators are necessary. We anticipate that the services of the Biostatistics and Bioinformatics Core will be used by all research projects and will also interact with the other cores. These services include preclinical and molecular studies as well as clinical trials. The benefit of having this core is that it provides a consistent team of dedicated personnel to efficiently support these activities. The Core’s aims are:
Specific Aim 1: To provide statistical and bioinformatic expertise in experimental design, data analysis and interpretation. The core will be involved in the studies from the conception stage all the way to its completion and dissemination.
Specific Aim 2: To develop and/or adapt and implement novel statistical and bioinformatic methodologies to meet need when standard methods are less than optimal.
Specific Aim 3: To provide informatics infrastructure to enable collaboration and data sharing among the various projects and the three institutions that constitute this spore.