Grant Details

This program invites applications for P50 Research Center Grants for Specialized Programs of Research Excellence (SPOREs) in organ-specific or groups of highly related cancers. The program targets applicant institutions with demonstrated ability to conduct translational research in the prevention, early detection,diagnosis, and/or treatment of human cancer. Applications may address cancer in any organ site, but each application must be organ site specific or address cancers that are related. Traditionally, these have included leukemias, lymphomas, myelomas, sarcomas, and cancers of brain, breast, gastrointestinal (GI) system, bladder, kidney, cervix, endometrium, head & neck, lung, ovary, pancreas, prostate, skin, oral cavity & pharynx, eye & orbit, and endocrine system. In recent years, applications have been also encouraged when they focus on pathway-driven or other novel cross-cutting themes that have potential for innovation and high scientific impact. Applicants are encouraged to consult with the Translational Research Program (TRP) staff members regarding the focus of their application.

All proposed SPORE projects must be translational. In every SPORE project, the development of new cancer-relevant interventions should include both a laboratory component and a human application that must be performed at some time during the 5-year term of the grant. When human biospecimens are the starting point for SPORE projects, these biospecimens must be used to study the biological basis of observations made in humans. For the purpose of these Guidelines, such human applications are defined as the human endpoints.

At least one of the following types of human endpoints should be proposed in each SPORE research project:

• Early phase clinical trials of new investigational drugs and biologics, experimental procedures, medical devices, or combinations thereof, or
• Early phase clinical trials of new combinations or new uses of the FDA-approved agents and devices, or
• Discovery and development of biomarkers, only when measurements are made in human specimens, or directly in human subjects, or
• IND-directed toxicology studies* conducted following a pre-IND meeting with the FDA in which the plan proposed by the investigators is acceptable to the FDA, or
• Population, behavioral, or psychosocial studies, when these studies address mechanistic aspects of the biology of the disease, or
• Clinical studies that lead to laboratory studies, which address new clinical hypotheses.

Experiments using cell lines, xenografts, or tumor grafts (using primary human tumors) may be important to the translational studies proposed and are encouraged, but are not sufficient to meet the human endpoint requirement.

Potential applicants are advised to consult with the NCI Scientific/Research staff listed in Section VII. Agency Contacts to clarify whether the proposed aims and research strategy are programmatically appropriate.

*The TRP realizes that IND-directed toxicology studies do not involve human beings, but as these studies are the last steps before clinical trials begin, they are considered programmatically appropriate as a human endpoint for SPORE translational projects.

The SPORE program fosters highly interactive translational research based on a unique approach with the following characteristics:

• Focuses solely on translational research, using a team science approach, with at least four scientific projects, containing at least one specific aim that reaches a human end-point within 5 years.
• In addition to translational research that involves basic research discoveries being applied in the clinic, the SPORE program encourages translational research projects that start with a clinical observation and return to the laboratory to explore the underlying biological mechanisms.
• Allows flexibility to change research directions during the grant period in order to pursue the most promising projects; research projects that demonstrate little or no translational progress may be terminated and replaced with new projects that have greater translational potential.
• Encourages projects on early detection, prevention or population science (defined below).
• Requires collaborations among individual SPORE awardees (inter-SPORE collaborations) and/or collaborations between individual SPOREs and other research programs.
• Encourages early phase clinical trials and handing off later trials to other mechanisms including industry and other governmental and non-governmental mechanisms.
• Expects each individual SPORE awardee and the "network" of SPOREs to conduct research that will have the most immediate impact possible on reducing incidence and mortality of human cancer.

Inherent in this process is the interdependence between investigators conducting basic and applied research. Clinical and/or epidemiological research that does not include a laboratory component or capitalize upon a biological discovery relevant to human cancer is not considered translational for the SPORE.