Fellowships Grants and Awards April 2004
Journal: Environmental Health Perspectives (2004)

The National Cancer Institute (NCI) invites investigators to form strategic partnerships that will bring together the multidisciplinary expertise and resources needed to determine how the information derived from comprehensive molecular analyses can be used to improve patient care and, ultimately, patient outcomes.The purpose of this request for applications (RFA) is to build on recent demonstrations that molecular signatures correlate with important clinical parameters in cancer.Applicants are asked to propose evaluation of potential clinical usefulness of molecular signatures already developed using a variety of molecular analysis technologies including DNA-, RNA-, or protein-based technologies.Retrospective studies have shown that molecular signatures have identified subgroups of patients whose tumors are histopathologically the same but who have different clinical outcomes.The challenge is to translate the information in these molecular signatures into tools that can be used in clinical decision making.To meet this challenge, signatures must be confirmed in independent studies.Critical elements of signatures that correlate most strongly with the clinical end point of interest must be identified and confirmed.Robust assays feasible for use in the clinical setting must be developed and validated.This open competition will provide the cancer research community the opportunity to establish collaborations focused on the translation of promising molecular profiles toward clinical applications.The NCI will continue the policy of requiring public release in a timely fashion of the rich data sets generated during these projects.Access to these data sets will benefit the entire cancer research community.This initiative will help ensure that the NCI goal of eliminating the suffering and death from cancer by 2015 is met.The ability of molecular profiles to provide useful clinical information is being demonstrated in many projects throughout the cancer research community and must be evaluated further.Scientists are discovering molecular signatures by analysis of gene expression at the RNA level, gene expression following protein translation, gene mutations, DNA deletions, DNA amplifications, epigenetic changes of DNA, and posttranslational modification of proteins.The challenge is to move beyond the initial discovery of potentially useful profiles, to decide what subset of the elements in the profiles needs to be measured, to confirm that the profiles are robust and can be reproducibly measured, and to evaluate the clinical utility of the profiles.This RFA is intended to support projects carrying out the extensive research needed to bridge the gap between discovery of molecular profiles and their integration into clinical decision making.Collaborations must be established to provide all of the expertise and clinical resources required to achieve proposed project goals.It is anticipated that these will be multi-institutional projects involving investigators with expertise in technology development and application, cancer biology, oncology, pathology, clinical cancer research, biostatistics, bioinformatics, and, possibly, biomedical imaging.Applicants must propose projects that build on previously identified molecular profiles.Applications proposing only profile discovery or technology development projects will not be considered responsive to this RFA.The proposed studies should be designed to confirm and refine signatures that have been demonstrated to provide information that is potentially useful clinically and that may be used to aid in making clinical decisions.Applicants may propose to define critical components in the signature, to confirm that the selected components continue to provide the desired clinical