Academic journal article Environmental Health Perspectives

NHLBI Clinical Proteomics Programs

Academic journal article Environmental Health Perspectives

NHLBI Clinical Proteomics Programs

Article excerpt

This Request for Application (RFA) will establish Clinical Proteomics Programs to promote systematic, comprehensive, large-scale validation of existing and new candidate protein markers that are appropriate for routine use in the diagnosis and management of heart, lung, blood, and sleep diseases. These programs will facilitate validation of protein panels that may be used to predict disease susceptibility or to assist in differential diagnosis, disease staging, selection of individualized therapies, or monitoring of treatment responses. In addition, this RFA seeks to establish a high quality education and skills development program to encourage and ensure that scientists develop competencies and expertise needed to address the complex, multifaceted challenges in clinical proteomics.

Heart, lung, blood, and sleep diseases are major causes of morbidity and mortality. Cardiovascular disease is the number one killer in the United States in both men and women, across all major racial groups and totals nearly one million deaths a year. Lung diseases such as chronic bronchitis, emphysema, asthma and other obstructive or interstitial conditions account for more than 230,000 deaths annually, placing an enormous burden on our healthcare system. Blood diseases such as venous thrombosis and pulmonary embolisms are causes of significant public health concern, as well. Sleep disorders and insufficient sleep represent severe health concerns for tens of millions of Americans.

Improving patient care through the use of protein markers is well established clinically. For example, the definition of heart attack, as well as the determination of the benefit derived from antithrombotic treatments, rests on serum troponin measurement. The detection of extremely small quantities of this protein identifies patients at high risk for adverse outcomes as well those that will derive greater benefit from antithrombotic and other interventional strategies. Assay of the B-type natriuretic peptide also contributes to standard clinical information in the diagnosis of congestive heart failure. Myeloperoxidase was recently shown to help in the diagnosis of atherosclerosis and acute coronary syndromes.

The predictive values, sensitivity, and specificity of many of the individual protein markers, currently in clinical use, could potentially be enhanced if analyzed and measured in a panel. Observational studies have shown that combining protein markers troponin I, C-reactive protein and B-type natriuretic peptide into panels can provide valuable information on stratifying risk for acute coronary syndromes. Panels of protein markers, appropriately validated, could facilitate better and earlier diagnosis, improve disease staging and selection of individual therapies and lead to more reliable monitoring of treatment responses, leading to substantial improvements in public health.

The application of proteomics in the clinical environment is limited due to a lack of knowledge regarding which proteins are most useful for analysis and how data are interpreted and represented. Important research needs include the identification of panels of protein markers that are likely to provide useful clinical information, design of practical assays for these panels, and validation of these panels and assays in well characterized populations of human subjects. The emergence of clinical proteomics promises major advances in disease management, provided that a continuous channel exists for translating protein discoveries into tangible clinical benefits.

The purpose of this RFA is to establish an infrastructure for research teams to validate protein panels and to measure multiple candidate markers accurately, for heart, lung, blood, and sleep diseases. The Clinical Proteomics Programs established for this purpose will design panels of candidate proteins for disease areas, develop high throughput analytic methods, assess the predictive value of these proteomic measurements using biological specimens and clinical data from existing study populations, and establish procedures and standards for quality control. …

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