Standardizing cancer biomarkers criteria: data elements as a foundation for a database. Inflammatory mediator/M-CSF as model marker |
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Authors: | Mahin Khatami |
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Institution: | (1) Technology Program Development, Office of Technology and Industrial Relations, Office of the Director, National Cancer Institute/NCI/NIH, DHHS, Bethesda, MD, USA |
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Abstract: | The purpose of this position article was to design a set of criteria (data elements) for a wide range of cancer biomarkers
(CBs) in an attempt to standardize biomarkers features through a common language as a foundation for a database. Data elements
are described as a set of generic criteria, which should characterize nearly all biomarkers introduced in the literature.
Data elements were extracted from the review of prominent features that biomarkers represent within various categories. The
extracted characteristics of biomarkers produced a short list of shared and unique generic features such as biological nature
and history; stage/phase of study; sensitivity and specificity; modes of action; risk assessment; validation status; technology,
and recommendation status for diversified biomarkers. To tailor data elements on specific markers, a cytokine, such as macrophage-colony
stimulating factor (M-CSF), which has been proposed as a ‹potentially suitable biomarker’ for diagnosis of ovarian, lung,
breast, pancreatic, and colorectal cancers, was selected as a Model biomarker. Small scale clinical studies suggested the
superior usefulness of M-CSF compared with traditional markers for cancer detection. A key criterion for selecting Model marker
and tailoring data elements for detection of cancer was the comparison of data on its specificity and sensitivity with traditional
markers. The design of data elements for standardizing CBs criteria is considered a Research Tool and a foundation for developing
a comprehensive CBs database useful for oncology researchers for a wide range of biomarkers. Validation, integration and proper
packaging, data visualization and recommendation of suitability of CBs, by a panel of experts, for technology development
are important challenging next steps toward developing a reliable database, which would allow professionals to effectively
retrieve and study integrated information on potentially useful markers; identify important knowledge gaps and limitations
of data; and assess state of technologies and commercialization of markers at a point of need. Appropriate use of integrated
information on biomarkers in clinical practices would eventually account for more cost-effective characteristics of an individual’s
state of health. |
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Keywords: | Cancer biomarkers Data elements Standardizing biomarkers criteria Database Inflammatory mediators Macrophage colony-stimulating factor Early detection Chemoprevention Therapy Oncology |
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