Journal of IiME Volume 6 Issue 1 (June 2012) clinicians with respect to pathogenesis, aetiology, diagnostic criteria and treatment strategies. Perhaps the greatest challenge to making strides in CFS/ME research is the very nature of this disorder, which is multisystem in scope (both symptoms and pathogenesis); heterogeneous in onset, duration, aetiology; and lacking in specific simple objective and reproducible biomarkers. Over the past decade, there has been worldwide emphasis on translational medicine to increase the effectiveness of basic research in order to bring appropriate diagnostics and therapies to patient groups in a more cost-effective, orderly, and timely fashion. This philosophical change is reflected in many of the recent studies employed for the study of CFS/ME. Additionally, there has been increased emphasis on integrating informational technology to the study of CFS/ME in order to establish geographically diverse databases and biobanks from which basic researchers as well as clinicians can search, contribute to, and utilize in their respective disciplines. The CFIDS Association of America has been at the forefront of sponsoring and funding for small pilot projects, particularly seeking innovative approaches to research into CFS/ME with specific timelines and objectives. In 2012, six such studies were selected from a large number of qualified projects and are now underway. These studies will be discussed with respect to study design, objectives, and progress. The NIH recently sponsored a multi-centered study under the direction of Ian Lipkin at Columbia University to validate the findings of XMRV previously reported by other researchers. The study has now been completed. The multicentered study design will be presented. Results are expected to be published in the near future. The Chronic Fatigue Initiative, has designed and supported a multi-centered study, "A Clinical and Biosample Database to Enable Discovery of Pathogens and Pathogenic Mechanisms in Chronic Fatigue Syndrome" to look at an extensive array of clinical aspects of patients with CFS/ME with particular emphasis on patients with acute viral type of onset (duration less than 3 years) versus patients with longstanding illness and classical patients as described both clinically and in the Invest in ME (Charity Nr. 1114035) laboratory. A large database is currently being collected with respect to family history, onset, natural history, and associated laboratory findings including serologies, immunological studies, neuroimaging, and functional studies (such as sleep studies, and exercise tolerance tests). Phase 1 of this initiative will evaluate patients and controls for the presence of known human pathogens as well as potential novel agents using the technology available at the Center for Infection and Immunity at the Mailman School of Public Health at Columbia University. This study already has significant enrolment at multiple centers and preliminary results may be available shortly. Phase 2 of the Chronic Fatigue Initiative effort will provide support for investigator initiated projects and access to databases and biobank repositories. Details of the study design, inclusion/exclusion criteria, and timelines will be presented. There has been increased interest in the study of cerebrospinal fluid due to the multiple neurological symptoms and objective findings by neuroimaging that CFS/ME patients demonstrate. A study looking at cerebrospinal fluid in patients with CFS/ME versus multiple sclerosis patients and normal controls has recently been launched. This project is named “Collaborative Research Using Cerebrospinal Fluid Novel Pathogen Discovery” and will use the technology available at the Center for Infection and Immunity. In collaboration with Population Health and Neuroimmunology Unit (PHANU) at Bond University in Australia, a pilot project was initiated to evaluate cytokines and microRNA in the spinal fluid. Correlating these findings with peripheral blood with special attention to Natural Killer Cell function and phenotypes may produce clinically relevant biomarkers. Lastly, a collaborative effort with the acronym CASA (Collection, Aggregation, Storage and Analysis) has recently joined resources of the NIH, CDC, clinicians, and researchers with diverse backgrounds to evaluate by consensus domains of a critical nature to the study of CFS/ME. One of the goals of this collaboration is to establish standards for research in the area of CFS/ME with particular emphasis on determining appropriate tools. These include questionnaires, laboratory studies, histories, and physical examinations which have been validated and recommended for www.investinme.org Page 105 of 108
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