While early stage cancers that were heretofore undetectable can now be detected by screening, many lesions detected by imaging or biomarkers are not cancer and many of the detected cancers are not life threatening. Simply stated, although it is possible to detect early stage cancers with greater frequency, one does not always know which lesions are cancer and cannot always distinguish cancers that are life threatening from those that are not.
Overdiagnosis is the term used when the diagnosis of a disease is correctly made, but the disease does not give rise to symptoms during the patient’s lifetime or have lethal potential for the patient. False positive is the term used when the test for disease in a patient is “positive” when the disease is not present. Our inability to differentiate lethal from indolent cancer (frequently over diagnosed), particularly at an early stage, and to differentiate benign disease from cancer (false positives) is a significant clinical problem.
The goal of this FOA is to develop improved methods for the early detection of aggressive cancer by managing overdiagnosis, reducing false positives and identifying lethal cancers from non-lethal disease using strategies aimed at effective integration and validation of imaging and biomarkers. It is acknowledged that a biomarker is conceptually defined as a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes or a biological response that could be used for early cancer detection.
While imaging and biomarkers can both be derived from tissue, cancer cells, serum, plasma, urine or other bodily fluids, for the purpose of this FOA, a biomarker will specifically refer to results obtained from the analysis of biofluids and tissues that are not spatially or temporally resolved. Likewise, imaging is referred to as a “tool” used to graphically depict spatially or temporally resolved cancer cells, tissues and their surroundings. In the context of this FOA, imaging can employ any of a variety of radiographic, sonographic, and other diagnostic technologies. Imaging and biomarker tests used in this fashion are obtained separately and serially as a function of time. An imageable biomarker, for the purpose of this FOA, combines structural and/or functional information from one or more biomarker(s) and imaging obtained simultaneously (rather than serially) resulting in a visual representation of cancer cells, cellular features, molecular analytes, or image derived features (genomic, proteomics, metabolomics, or other “omics” data including radiomic approaches) that may or may not be directly mapped for visualization, but are nonetheless associated with and derived from image-based acquisitions. Data obtained in this manner can include morphologic/physiologic relationships and connectivities related to individual pixel/voxel characteristics, meta data, features and numerical associations that correlate to disease processes and aberrant metabolic pathways, or other information that could be applied clinically in the context of precision medicine.
Deadlines: May 25, 2016; September 26, 2016; January 25, 2017; May 25, 2017; September 26, 2017; January 25, 2018; May 25, 2018; September 26, 2018; and January 25, 2019
Filed Under: Funding Opportunities