Validation of standard operating procedures in a multicenter retrospective study to identify -omics biomarkers for chronic low back pain

May Validation of standard operating procedures in a multicenter retrospective study to identify -omics biomarkers for chronic low back pain Concetta Dagostino 0 1 2 Manuela De Gregori 0 2 Christian Gieger 0 2 Judith Manz 0 2 Ivan Gudelj 0 2 Gordan Lauc 0 2 Laura Divizia 0 2 Wei Wang 0 2 4 Moira Sim 0 2 4 Iain K. Pemberton 0 2 3 Jane MacDougall 0 2 3 Frances Williams 0 2 Jan Van Zundert 0 2 5 Dragan Primorac 0 2 9 0 Yurii Aulchenko 1 Anesthesia, Critical Care and Pain Medicine Unit, Division of Surgical Sciences, Department of Medicine and Surgery, University of Parma , Parma , Italy , 2 PainTherapy Service, Fondazione IRCCS Policlinico San Matteo , Pavia , Italy , 3 Institute of Epidemiology II, Research Unit of Molecular Epidemiology, Helmholtz Zentrum MuÈnchen, German Research Center for Environmental Health , Neuherberg, Germany, 4 Genos , Glycoscience Research Laboratory, Zagreb, Croatia, 5 Laboratory of Biochemistry and Genetics, Division of Pneumology, Department of Molecular Medicine, Fondazione IRCCS Policlinico San Matteo , Pavia , Italy 2 Editor: Dino Samartzis, University of Hong Kong , HONG KONG 3 IP Research Consulting SASU (PHOTEOMIX) - Rex de Chausse e , Noisy le Grand , France , 8 Department of Twin Research and Genetic Epidemiology, King's College London , London , United Kingdom 4 School of Medical and Health Sciences, Edith Cowan University , Joondalup, Western Australia , Australia 5 Department of Anesthesiology, Critical Care and Multidisciplinary Pain Center, Ziekenhuis Oost-Limburg , Genk, Belgium, 10 St. Catherine Specialty Hospital , Zabok , Croatia , 11 Eberly College of Science, The Pennsylvania State University, University Park, Pennsylvania, United States of America, 12 University of Split School of Medicine, Split, Croatia, 13 University of Osijek School of Medicine , Osijek , Croatia 6 , Leonardo Kapural 7 Carolinas Pain Institute , Winston-Salem, North Carolina , United States of America 8 Membership of the PainOmics Group is provided in the Acknowledgments 9 Children's Hospital Srebrnjak , Zagreb, Croatia, 15 PolyOmica, Groningen , The Netherlands Chronic low back pain (CLBP) is one of the most common medical conditions, ranking as the greatest contributor to global disability and accounting for huge societal costs based on Large genetic and -omics studies provide a promising avenue for the screening, development and validation of biomarkers useful for personalized diagnosis and treatment (precision medicine). Multicentre studies are needed for such an effort, and a standardized and homogeneous approach is vital for recruitment of large numbers of participants among different centres (clinical and laboratories) to obtain robust and reproducible results. To date, no validated standard operating procedures (SOPs) for genetic/-omics studies in chronic pain have been developed. Data Availability Statement; All relevant data (figures; tables; legends and appendix) are within the paper and its Supporting Information files - Funding: The present study is not funded by Industry or any other commercial sponsors. This trial is funded academic research; it is supported by funding from the European Commission FP7 Project in the context of the THEME [HEALTH.2013.2.2.1-5 - Understanding and controlling pain] named ªPainOmicsº (Grant retrospective ªPainOmicsº study, funded by the European Community in the 7th Framework Programme, which aims to develop new biomarkers for CLBP through three different -omics approaches: genomics, glycomics and activomics. agreement no: 602736). The funds received from the European grant provided support in the form of salaries for authors (CD, MDG, GL, JMD, YA) but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the `author contributions' section. Competing interests: The authors stated that there are no conflicts of interest regarding the publication of this article. MA has received consultant fees or research grants from GruÈnenthal, Angelini, Mundipharma, MSD and Care Fusion. GL has multiple patents in the field of glycoscience issued. IKP and JMD are scientific directors of Photeomix, the commercial name of IP Research Consulting SAS, who have ongoing patent applications and trademarks related to Activomics. YA is a director and co-owner of Maatschap PolyOmica, which provides (consulting) services in the area of (statistical) (gen)omics. This does not alter our adherence to PLOS ONE policies on sharing data and materials. The SOPs describe the specific procedures for (1) blood collection, (2) sample process ing and storage, (3) shipping details and (4) cross-check testing and validation before assays that all the centres involved in the study have to follow. Multivariate analysis revealed the absolute specificity and homogeneity of the samples collected by the five centres for all genetics, glyc (...truncated)