Validation of standard operating procedures in a multicenter retrospective study to identify -omics biomarkers for chronic low back pain
Identifieur interne : 002825 ( Pmc/Curation ); précédent : 002824; suivant : 002826Validation of standard operating procedures in a multicenter retrospective study to identify -omics biomarkers for chronic low back pain
Auteurs : Concetta Dagostino [Italie] ; Manuela De Gregori [Italie] ; Christian Gieger [Allemagne] ; Judith Manz [Allemagne] ; Ivan Gudelj [Croatie] ; Gordan Lauc [Croatie] ; Laura Divizia [Italie] ; Wei Wang [Australie] ; Moira Sim [Australie] ; Iain K. Pemberton [France] ; Jane Macdougall [France] ; Frances Williams [Royaume-Uni] ; Jan Van Zundert [Belgique] ; Dragan Primorac [Croatie, États-Unis] ; Yurii Aulchenko [Pays-Bas] ; Leonardo Kapural [États-Unis] ; Massimo Allegri [Italie]Source :
- PLoS ONE [ 1932-6203 ] ; 2017.
Abstract
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 the Global Burden of Disease 2010 study.
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.
In this study, we validated an SOP model that will be used in the multicentre (5 centres) retrospective “PainOmics” 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.
The SOPs describe the specific procedures for (
Multivariate analysis revealed the absolute specificity and homogeneity of the samples collected by the five centres for all genetics, glycomics and activomics analyses.
The SOPs used in our multicenter study have been validated. Hence, they could represent an innovative tool for the correct management and collection of reliable samples in other large-omics-based multicenter studies.
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DOI: 10.1371/journal.pone.0176372
PubMed: 28459826
PubMed Central: 5411039
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Validation of standard operating procedures in a multicenter retrospective study to identify -omics biomarkers for chronic low back pain</title><author><name sortKey="Dagostino, Concetta" sort="Dagostino, Concetta" uniqKey="Dagostino C" first="Concetta" last="Dagostino">Concetta Dagostino</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Anesthesia, Critical Care and Pain Medicine Unit, Division of Surgical Sciences, Department of Medicine and Surgery, University of Parma, Parma, Italy</addr-line></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Anesthesia, Critical Care and Pain Medicine Unit, Division of Surgical Sciences, Department of Medicine and Surgery, University of Parma, Parma</wicri:regionArea></affiliation></author><author><name sortKey="De Gregori, Manuela" sort="De Gregori, Manuela" uniqKey="De Gregori M" first="Manuela" last="De Gregori">Manuela De Gregori</name><affiliation wicri:level="1"><nlm:aff id="aff002"><addr-line>PainTherapy Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy</addr-line></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>PainTherapy Service, Fondazione IRCCS Policlinico San Matteo, Pavia</wicri:regionArea></affiliation></author><author><name sortKey="Gieger, Christian" sort="Gieger, Christian" uniqKey="Gieger C" first="Christian" last="Gieger">Christian Gieger</name><affiliation wicri:level="1"><nlm:aff id="aff003"><addr-line>Institute of Epidemiology II, Research Unit of Molecular Epidemiology, Helmholtz Zentrum München, German Research Center for Environmental Health, Neuherberg, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute of Epidemiology II, Research Unit of Molecular Epidemiology, Helmholtz Zentrum München, German Research Center for Environmental Health, Neuherberg</wicri:regionArea></affiliation></author><author><name sortKey="Manz, Judith" sort="Manz, Judith" uniqKey="Manz J" first="Judith" last="Manz">Judith Manz</name><affiliation wicri:level="1"><nlm:aff id="aff003"><addr-line>Institute of Epidemiology II, Research Unit of Molecular Epidemiology, Helmholtz Zentrum München, German Research Center for Environmental Health, Neuherberg, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute of Epidemiology II, Research Unit of Molecular Epidemiology, Helmholtz Zentrum München, German Research Center for Environmental Health, Neuherberg</wicri:regionArea></affiliation></author><author><name sortKey="Gudelj, Ivan" sort="Gudelj, Ivan" uniqKey="Gudelj I" first="Ivan" last="Gudelj">Ivan Gudelj</name><affiliation wicri:level="1"><nlm:aff id="aff004"><addr-line>Genos, Glycoscience Research Laboratory, Zagreb, Croatia</addr-line></nlm:aff><country xml:lang="fr">Croatie</country><wicri:regionArea>Genos, Glycoscience Research Laboratory, Zagreb</wicri:regionArea></affiliation></author><author><name sortKey="Lauc, Gordan" sort="Lauc, Gordan" uniqKey="Lauc G" first="Gordan" last="Lauc">Gordan Lauc</name><affiliation wicri:level="1"><nlm:aff id="aff004"><addr-line>Genos, Glycoscience Research Laboratory, Zagreb, Croatia</addr-line></nlm:aff><country xml:lang="fr">Croatie</country><wicri:regionArea>Genos, Glycoscience Research Laboratory, Zagreb</wicri:regionArea></affiliation></author><author><name sortKey="Divizia, Laura" sort="Divizia, Laura" uniqKey="Divizia L" first="Laura" last="Divizia">Laura Divizia</name><affiliation wicri:level="1"><nlm:aff id="aff005"><addr-line>Laboratory of Biochemistry and Genetics, Division of Pneumology, Department of Molecular Medicine, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy</addr-line></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Laboratory of Biochemistry and Genetics, Division of Pneumology, Department of Molecular Medicine, Fondazione IRCCS Policlinico San Matteo, Pavia</wicri:regionArea></affiliation></author><author><name sortKey="Wang, Wei" sort="Wang, Wei" uniqKey="Wang W" first="Wei" last="Wang">Wei Wang</name><affiliation wicri:level="1"><nlm:aff id="aff006"><addr-line>School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia</addr-line></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia</wicri:regionArea></affiliation></author><author><name sortKey="Sim, Moira" sort="Sim, Moira" uniqKey="Sim M" first="Moira" last="Sim">Moira Sim</name><affiliation wicri:level="1"><nlm:aff id="aff006"><addr-line>School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia</addr-line></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia</wicri:regionArea></affiliation></author><author><name sortKey="Pemberton, Iain K" sort="Pemberton, Iain K" uniqKey="Pemberton I" first="Iain K." last="Pemberton">Iain K. Pemberton</name><affiliation wicri:level="1"><nlm:aff id="aff007"><addr-line>IP Research Consulting SASU (PHOTEOMIX) - Rex de Chaussée, Noisy le Grand, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>IP Research Consulting SASU (PHOTEOMIX) - Rex de Chaussée, Noisy le Grand</wicri:regionArea></affiliation></author><author><name sortKey="Macdougall, Jane" sort="Macdougall, Jane" uniqKey="Macdougall J" first="Jane" last="Macdougall">Jane Macdougall</name><affiliation wicri:level="1"><nlm:aff id="aff007"><addr-line>IP Research Consulting SASU (PHOTEOMIX) - Rex de Chaussée, Noisy le Grand, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>IP Research Consulting SASU (PHOTEOMIX) - Rex de Chaussée, Noisy le Grand</wicri:regionArea></affiliation></author><author><name sortKey="Williams, Frances" sort="Williams, Frances" uniqKey="Williams F" first="Frances" last="Williams">Frances Williams</name><affiliation wicri:level="1"><nlm:aff id="aff008"><addr-line>Department of Twin Research and Genetic Epidemiology, King’s College London, London, United Kingdom</addr-line></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Twin Research and Genetic Epidemiology, King’s College London, London</wicri:regionArea></affiliation></author><author><name sortKey="Van Zundert, Jan" sort="Van Zundert, Jan" uniqKey="Van Zundert J" first="Jan" last="Van Zundert">Jan Van Zundert</name><affiliation wicri:level="1"><nlm:aff id="aff009"><addr-line>Department of Anesthesiology, Critical Care and Multidisciplinary Pain Center, Ziekenhuis Oost-Limburg, Genk, Belgium</addr-line></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea>Department of Anesthesiology, Critical Care and Multidisciplinary Pain Center, Ziekenhuis Oost-Limburg, Genk</wicri:regionArea></affiliation></author><author><name sortKey="Primorac, Dragan" sort="Primorac, Dragan" uniqKey="Primorac D" first="Dragan" last="Primorac">Dragan Primorac</name><affiliation wicri:level="1"><nlm:aff id="aff010"><addr-line>St. Catherine Specialty Hospital, Zabok, Croatia</addr-line></nlm:aff><country xml:lang="fr">Croatie</country><wicri:regionArea>St. Catherine Specialty Hospital, Zabok</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff011"><addr-line>Eberly College of Science, The Pennsylvania State University, University Park, Pennsylvania, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Eberly College of Science, The Pennsylvania State University, University Park, Pennsylvania</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff012"><addr-line>University of Split School of Medicine, Split, Croatia</addr-line></nlm:aff><country xml:lang="fr">Croatie</country><wicri:regionArea>University of Split School of Medicine, Split</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff013"><addr-line>University of Osijek School of Medicine, Osijek, Croatia</addr-line></nlm:aff><country xml:lang="fr">Croatie</country><wicri:regionArea>University of Osijek School of Medicine, Osijek</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff014"><addr-line>Children's Hospital Srebrnjak, Zagreb, Croatia</addr-line></nlm:aff><country xml:lang="fr">Croatie</country><wicri:regionArea>Children's Hospital Srebrnjak, Zagreb</wicri:regionArea></affiliation></author><author><name sortKey="Aulchenko, Yurii" sort="Aulchenko, Yurii" uniqKey="Aulchenko Y" first="Yurii" last="Aulchenko">Yurii Aulchenko</name><affiliation wicri:level="1"><nlm:aff id="aff015"><addr-line>PolyOmica, Groningen, The Netherlands</addr-line></nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>PolyOmica, Groningen</wicri:regionArea></affiliation></author><author><name sortKey="Kapural, Leonardo" sort="Kapural, Leonardo" uniqKey="Kapural L" first="Leonardo" last="Kapural">Leonardo Kapural</name><affiliation wicri:level="1"><nlm:aff id="aff016"><addr-line>Carolinas Pain Institute, Winston-Salem, North Carolina, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Carolinas Pain Institute, Winston-Salem, North Carolina</wicri:regionArea></affiliation></author><author><name sortKey="Allegri, Massimo" sort="Allegri, Massimo" uniqKey="Allegri M" first="Massimo" last="Allegri">Massimo Allegri</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Anesthesia, Critical Care and Pain Medicine Unit, Division of Surgical Sciences, Department of Medicine and Surgery, University of Parma, Parma, Italy</addr-line></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Anesthesia, Critical Care and Pain Medicine Unit, Division of Surgical Sciences, Department of Medicine and Surgery, University of Parma, Parma</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">28459826</idno><idno type="pmc">5411039</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5411039</idno><idno type="RBID">PMC:5411039</idno><idno type="doi">10.1371/journal.pone.0176372</idno><date when="2017">2017</date><idno type="wicri:Area/Pmc/Corpus">002975</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">002975</idno><idno type="wicri:Area/Pmc/Curation">002825</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">002825</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Validation of standard operating procedures in a multicenter retrospective study to identify -omics biomarkers for chronic low back pain</title><author><name sortKey="Dagostino, Concetta" sort="Dagostino, Concetta" uniqKey="Dagostino C" first="Concetta" last="Dagostino">Concetta Dagostino</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Anesthesia, Critical Care and Pain Medicine Unit, Division of Surgical Sciences, Department of Medicine and Surgery, University of Parma, Parma, Italy</addr-line></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Anesthesia, Critical Care and Pain Medicine Unit, Division of Surgical Sciences, Department of Medicine and Surgery, University of Parma, Parma</wicri:regionArea></affiliation></author><author><name sortKey="De Gregori, Manuela" sort="De Gregori, Manuela" uniqKey="De Gregori M" first="Manuela" last="De Gregori">Manuela De Gregori</name><affiliation wicri:level="1"><nlm:aff id="aff002"><addr-line>PainTherapy Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy</addr-line></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>PainTherapy Service, Fondazione IRCCS Policlinico San Matteo, Pavia</wicri:regionArea></affiliation></author><author><name sortKey="Gieger, Christian" sort="Gieger, Christian" uniqKey="Gieger C" first="Christian" last="Gieger">Christian Gieger</name><affiliation wicri:level="1"><nlm:aff id="aff003"><addr-line>Institute of Epidemiology II, Research Unit of Molecular Epidemiology, Helmholtz Zentrum München, German Research Center for Environmental Health, Neuherberg, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute of Epidemiology II, Research Unit of Molecular Epidemiology, Helmholtz Zentrum München, German Research Center for Environmental Health, Neuherberg</wicri:regionArea></affiliation></author><author><name sortKey="Manz, Judith" sort="Manz, Judith" uniqKey="Manz J" first="Judith" last="Manz">Judith Manz</name><affiliation wicri:level="1"><nlm:aff id="aff003"><addr-line>Institute of Epidemiology II, Research Unit of Molecular Epidemiology, Helmholtz Zentrum München, German Research Center for Environmental Health, Neuherberg, Germany</addr-line></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute of Epidemiology II, Research Unit of Molecular Epidemiology, Helmholtz Zentrum München, German Research Center for Environmental Health, Neuherberg</wicri:regionArea></affiliation></author><author><name sortKey="Gudelj, Ivan" sort="Gudelj, Ivan" uniqKey="Gudelj I" first="Ivan" last="Gudelj">Ivan Gudelj</name><affiliation wicri:level="1"><nlm:aff id="aff004"><addr-line>Genos, Glycoscience Research Laboratory, Zagreb, Croatia</addr-line></nlm:aff><country xml:lang="fr">Croatie</country><wicri:regionArea>Genos, Glycoscience Research Laboratory, Zagreb</wicri:regionArea></affiliation></author><author><name sortKey="Lauc, Gordan" sort="Lauc, Gordan" uniqKey="Lauc G" first="Gordan" last="Lauc">Gordan Lauc</name><affiliation wicri:level="1"><nlm:aff id="aff004"><addr-line>Genos, Glycoscience Research Laboratory, Zagreb, Croatia</addr-line></nlm:aff><country xml:lang="fr">Croatie</country><wicri:regionArea>Genos, Glycoscience Research Laboratory, Zagreb</wicri:regionArea></affiliation></author><author><name sortKey="Divizia, Laura" sort="Divizia, Laura" uniqKey="Divizia L" first="Laura" last="Divizia">Laura Divizia</name><affiliation wicri:level="1"><nlm:aff id="aff005"><addr-line>Laboratory of Biochemistry and Genetics, Division of Pneumology, Department of Molecular Medicine, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy</addr-line></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Laboratory of Biochemistry and Genetics, Division of Pneumology, Department of Molecular Medicine, Fondazione IRCCS Policlinico San Matteo, Pavia</wicri:regionArea></affiliation></author><author><name sortKey="Wang, Wei" sort="Wang, Wei" uniqKey="Wang W" first="Wei" last="Wang">Wei Wang</name><affiliation wicri:level="1"><nlm:aff id="aff006"><addr-line>School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia</addr-line></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia</wicri:regionArea></affiliation></author><author><name sortKey="Sim, Moira" sort="Sim, Moira" uniqKey="Sim M" first="Moira" last="Sim">Moira Sim</name><affiliation wicri:level="1"><nlm:aff id="aff006"><addr-line>School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia</addr-line></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia</wicri:regionArea></affiliation></author><author><name sortKey="Pemberton, Iain K" sort="Pemberton, Iain K" uniqKey="Pemberton I" first="Iain K." last="Pemberton">Iain K. Pemberton</name><affiliation wicri:level="1"><nlm:aff id="aff007"><addr-line>IP Research Consulting SASU (PHOTEOMIX) - Rex de Chaussée, Noisy le Grand, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>IP Research Consulting SASU (PHOTEOMIX) - Rex de Chaussée, Noisy le Grand</wicri:regionArea></affiliation></author><author><name sortKey="Macdougall, Jane" sort="Macdougall, Jane" uniqKey="Macdougall J" first="Jane" last="Macdougall">Jane Macdougall</name><affiliation wicri:level="1"><nlm:aff id="aff007"><addr-line>IP Research Consulting SASU (PHOTEOMIX) - Rex de Chaussée, Noisy le Grand, France</addr-line></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>IP Research Consulting SASU (PHOTEOMIX) - Rex de Chaussée, Noisy le Grand</wicri:regionArea></affiliation></author><author><name sortKey="Williams, Frances" sort="Williams, Frances" uniqKey="Williams F" first="Frances" last="Williams">Frances Williams</name><affiliation wicri:level="1"><nlm:aff id="aff008"><addr-line>Department of Twin Research and Genetic Epidemiology, King’s College London, London, United Kingdom</addr-line></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Twin Research and Genetic Epidemiology, King’s College London, London</wicri:regionArea></affiliation></author><author><name sortKey="Van Zundert, Jan" sort="Van Zundert, Jan" uniqKey="Van Zundert J" first="Jan" last="Van Zundert">Jan Van Zundert</name><affiliation wicri:level="1"><nlm:aff id="aff009"><addr-line>Department of Anesthesiology, Critical Care and Multidisciplinary Pain Center, Ziekenhuis Oost-Limburg, Genk, Belgium</addr-line></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea>Department of Anesthesiology, Critical Care and Multidisciplinary Pain Center, Ziekenhuis Oost-Limburg, Genk</wicri:regionArea></affiliation></author><author><name sortKey="Primorac, Dragan" sort="Primorac, Dragan" uniqKey="Primorac D" first="Dragan" last="Primorac">Dragan Primorac</name><affiliation wicri:level="1"><nlm:aff id="aff010"><addr-line>St. Catherine Specialty Hospital, Zabok, Croatia</addr-line></nlm:aff><country xml:lang="fr">Croatie</country><wicri:regionArea>St. Catherine Specialty Hospital, Zabok</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff011"><addr-line>Eberly College of Science, The Pennsylvania State University, University Park, Pennsylvania, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Eberly College of Science, The Pennsylvania State University, University Park, Pennsylvania</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff012"><addr-line>University of Split School of Medicine, Split, Croatia</addr-line></nlm:aff><country xml:lang="fr">Croatie</country><wicri:regionArea>University of Split School of Medicine, Split</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff013"><addr-line>University of Osijek School of Medicine, Osijek, Croatia</addr-line></nlm:aff><country xml:lang="fr">Croatie</country><wicri:regionArea>University of Osijek School of Medicine, Osijek</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff014"><addr-line>Children's Hospital Srebrnjak, Zagreb, Croatia</addr-line></nlm:aff><country xml:lang="fr">Croatie</country><wicri:regionArea>Children's Hospital Srebrnjak, Zagreb</wicri:regionArea></affiliation></author><author><name sortKey="Aulchenko, Yurii" sort="Aulchenko, Yurii" uniqKey="Aulchenko Y" first="Yurii" last="Aulchenko">Yurii Aulchenko</name><affiliation wicri:level="1"><nlm:aff id="aff015"><addr-line>PolyOmica, Groningen, The Netherlands</addr-line></nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>PolyOmica, Groningen</wicri:regionArea></affiliation></author><author><name sortKey="Kapural, Leonardo" sort="Kapural, Leonardo" uniqKey="Kapural L" first="Leonardo" last="Kapural">Leonardo Kapural</name><affiliation wicri:level="1"><nlm:aff id="aff016"><addr-line>Carolinas Pain Institute, Winston-Salem, North Carolina, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Carolinas Pain Institute, Winston-Salem, North Carolina</wicri:regionArea></affiliation></author><author><name sortKey="Allegri, Massimo" sort="Allegri, Massimo" uniqKey="Allegri M" first="Massimo" last="Allegri">Massimo Allegri</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Anesthesia, Critical Care and Pain Medicine Unit, Division of Surgical Sciences, Department of Medicine and Surgery, University of Parma, Parma, Italy</addr-line></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Anesthesia, Critical Care and Pain Medicine Unit, Division of Surgical Sciences, Department of Medicine and Surgery, University of Parma, Parma</wicri:regionArea></affiliation></author></analytic><series><title level="j">PLoS ONE</title><idno type="eISSN">1932-6203</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>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 the Global Burden of Disease 2010 study.</p><p>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.</p><p>In this study, we validated an SOP model that will be used in the multicentre (5 centres) retrospective “PainOmics” 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.</p><p>The SOPs describe the specific procedures for (<italic>1</italic>) blood collection, (<italic>2</italic>) sample processing and storage, (<italic>3</italic>) shipping details and (<italic>4</italic>) cross-check testing and validation before assays that all the centres involved in the study have to follow.</p><p>Multivariate analysis revealed the absolute specificity and homogeneity of the samples collected by the five centres for all genetics, glycomics and activomics analyses.</p><p>The SOPs used in our multicenter study have been validated. Hence, they could represent an innovative tool for the correct management and collection of reliable samples in other large-omics-based multicenter studies.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Chou, R" uniqKey="Chou R">R Chou</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Freburger, Jk" uniqKey="Freburger J">JK Freburger</name></author><author><name sortKey="Holmes, Gm" uniqKey="Holmes G">GM Holmes</name></author><author><name sortKey="Agans, Rp" uniqKey="Agans R">RP Agans</name></author><author><name sortKey="Jackman, Am" uniqKey="Jackman A">AM Jackman</name></author><author><name sortKey="Darter, Jd" uniqKey="Darter J">JD Darter</name></author><author><name sortKey="Wallace, As" uniqKey="Wallace A">AS Wallace</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Meucci, Rd" uniqKey="Meucci R">RD Meucci</name></author><author><name sortKey="Fassa, Ag" 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<front><journal-meta><journal-id journal-id-type="nlm-ta">PLoS One</journal-id><journal-id journal-id-type="iso-abbrev">PLoS ONE</journal-id><journal-id journal-id-type="publisher-id">plos</journal-id><journal-id journal-id-type="pmc">plosone</journal-id><journal-title-group><journal-title>PLoS ONE</journal-title></journal-title-group><issn pub-type="epub">1932-6203</issn><publisher><publisher-name>Public Library of Science</publisher-name><publisher-loc>San Francisco, CA USA</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">28459826</article-id><article-id pub-id-type="pmc">5411039</article-id><article-id pub-id-type="doi">10.1371/journal.pone.0176372</article-id><article-id pub-id-type="publisher-id">PONE-D-16-27833</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Diagnostic Medicine</subject><subj-group><subject>Signs and Symptoms</subject><subj-group><subject>Pain</subject><subj-group><subject>Lower Back Pain</subject></subj-group></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Pathology and Laboratory Medicine</subject><subj-group><subject>Signs and Symptoms</subject><subj-group><subject>Pain</subject><subj-group><subject>Lower Back Pain</subject></subj-group></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Biology and Life Sciences</subject><subj-group><subject>Biochemistry</subject><subj-group><subject>Biomarkers</subject></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Biology and Life Sciences</subject><subj-group><subject>Anatomy</subject><subj-group><subject>Body Fluids</subject><subj-group><subject>Blood</subject><subj-group><subject>Blood Plasma</subject></subj-group></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Anatomy</subject><subj-group><subject>Body Fluids</subject><subj-group><subject>Blood</subject><subj-group><subject>Blood Plasma</subject></subj-group></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Biology and Life Sciences</subject><subj-group><subject>Physiology</subject><subj-group><subject>Body Fluids</subject><subj-group><subject>Blood</subject><subj-group><subject>Blood Plasma</subject></subj-group></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Physiology</subject><subj-group><subject>Body Fluids</subject><subj-group><subject>Blood</subject><subj-group><subject>Blood Plasma</subject></subj-group></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Biology and Life Sciences</subject><subj-group><subject>Anatomy</subject><subj-group><subject>Body Fluids</subject><subj-group><subject>Blood</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Anatomy</subject><subj-group><subject>Body Fluids</subject><subj-group><subject>Blood</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Biology and Life Sciences</subject><subj-group><subject>Physiology</subject><subj-group><subject>Body Fluids</subject><subj-group><subject>Blood</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Physiology</subject><subj-group><subject>Body Fluids</subject><subj-group><subject>Blood</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Research and Analysis Methods</subject><subj-group><subject>Research Design</subject><subj-group><subject>Retrospective Studies</subject></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Diagnostic Medicine</subject><subj-group><subject>Clinical Laboratory Sciences</subject><subj-group><subject>Clinical Laboratories</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Research and Analysis Methods</subject><subj-group><subject>Storage and Handling</subject><subj-group><subject>Specimen Storage</subject></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Research and Analysis Methods</subject><subj-group><subject>Database and Informatics Methods</subject><subj-group><subject>Biological Databases</subject><subj-group><subject>Genomic Databases</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Biology and Life Sciences</subject><subj-group><subject>Computational Biology</subject><subj-group><subject>Genome Analysis</subject><subj-group><subject>Genomic Databases</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Biology and Life Sciences</subject><subj-group><subject>Genetics</subject><subj-group><subject>Genomics</subject><subj-group><subject>Genome Analysis</subject><subj-group><subject>Genomic Databases</subject></subj-group></subj-group></subj-group></subj-group></subj-group></article-categories><title-group><article-title>Validation of standard operating procedures in a multicenter retrospective study to identify -omics biomarkers for chronic low back pain</article-title><alt-title alt-title-type="running-head">Validation of SOPs</alt-title></title-group><contrib-group><contrib contrib-type="author"><contrib-id authenticated="true" contrib-id-type="orcid">http://orcid.org/0000-0002-6746-6716</contrib-id><name><surname>Dagostino</surname><given-names>Concetta</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref><xref ref-type="corresp" rid="cor001">*</xref></contrib><contrib contrib-type="author"><name><surname>De Gregori</surname><given-names>Manuela</given-names></name><xref ref-type="aff" rid="aff002"><sup>2</sup></xref></contrib><contrib contrib-type="author"><name><surname>Gieger</surname><given-names>Christian</given-names></name><xref ref-type="aff" rid="aff003"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Manz</surname><given-names>Judith</given-names></name><xref ref-type="aff" rid="aff003"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Gudelj</surname><given-names>Ivan</given-names></name><xref ref-type="aff" rid="aff004"><sup>4</sup></xref></contrib><contrib contrib-type="author"><name><surname>Lauc</surname><given-names>Gordan</given-names></name><xref ref-type="aff" rid="aff004"><sup>4</sup></xref></contrib><contrib contrib-type="author"><name><surname>Divizia</surname><given-names>Laura</given-names></name><xref ref-type="aff" rid="aff005"><sup>5</sup></xref></contrib><contrib contrib-type="author"><name><surname>Wang</surname><given-names>Wei</given-names></name><xref ref-type="aff" rid="aff006"><sup>6</sup></xref></contrib><contrib contrib-type="author"><name><surname>Sim</surname><given-names>Moira</given-names></name><xref ref-type="aff" rid="aff006"><sup>6</sup></xref></contrib><contrib contrib-type="author"><name><surname>Pemberton</surname><given-names>Iain K.</given-names></name><xref ref-type="aff" rid="aff007"><sup>7</sup></xref></contrib><contrib contrib-type="author"><name><surname>MacDougall</surname><given-names>Jane</given-names></name><xref ref-type="aff" rid="aff007"><sup>7</sup></xref></contrib><contrib contrib-type="author"><name><surname>Williams</surname><given-names>Frances</given-names></name><xref ref-type="aff" rid="aff008"><sup>8</sup></xref></contrib><contrib contrib-type="author"><name><surname>Van Zundert</surname><given-names>Jan</given-names></name><xref ref-type="aff" rid="aff009"><sup>9</sup></xref></contrib><contrib contrib-type="author"><name><surname>Primorac</surname><given-names>Dragan</given-names></name><xref ref-type="aff" rid="aff010"><sup>10</sup></xref><xref ref-type="aff" rid="aff011"><sup>11</sup></xref><xref ref-type="aff" rid="aff012"><sup>12</sup></xref><xref ref-type="aff" rid="aff013"><sup>13</sup></xref><xref ref-type="aff" rid="aff014"><sup>14</sup></xref></contrib><contrib contrib-type="author"><name><surname>Aulchenko</surname><given-names>Yurii</given-names></name><xref ref-type="aff" rid="aff015"><sup>15</sup></xref></contrib><contrib contrib-type="author"><name><surname>Kapural</surname><given-names>Leonardo</given-names></name><xref ref-type="aff" rid="aff016"><sup>16</sup></xref></contrib><contrib contrib-type="author"><name><surname>Allegri</surname><given-names>Massimo</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref></contrib><contrib contrib-type="author"><collab>on behalf of the PainOmics Group</collab><xref ref-type="author-notes" rid="fn001"><sup>¶</sup></xref></contrib></contrib-group><aff id="aff001"><label>1</label><addr-line>Anesthesia, Critical Care and Pain Medicine Unit, Division of Surgical Sciences, Department of Medicine and Surgery, University of Parma, Parma, Italy</addr-line></aff><aff id="aff002"><label>2</label><addr-line>PainTherapy Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy</addr-line></aff><aff id="aff003"><label>3</label><addr-line>Institute of Epidemiology II, Research Unit of Molecular Epidemiology, Helmholtz Zentrum München, German Research Center for Environmental Health, Neuherberg, Germany</addr-line></aff><aff id="aff004"><label>4</label><addr-line>Genos, Glycoscience Research Laboratory, Zagreb, Croatia</addr-line></aff><aff id="aff005"><label>5</label><addr-line>Laboratory of Biochemistry and Genetics, Division of Pneumology, Department of Molecular Medicine, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy</addr-line></aff><aff id="aff006"><label>6</label><addr-line>School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia</addr-line></aff><aff id="aff007"><label>7</label><addr-line>IP Research Consulting SASU (PHOTEOMIX) - Rex de Chaussée, Noisy le Grand, France</addr-line></aff><aff id="aff008"><label>8</label><addr-line>Department of Twin Research and Genetic Epidemiology, King’s College London, London, United Kingdom</addr-line></aff><aff id="aff009"><label>9</label><addr-line>Department of Anesthesiology, Critical Care and Multidisciplinary Pain Center, Ziekenhuis Oost-Limburg, Genk, Belgium</addr-line></aff><aff id="aff010"><label>10</label><addr-line>St. Catherine Specialty Hospital, Zabok, Croatia</addr-line></aff><aff id="aff011"><label>11</label><addr-line>Eberly College of Science, The Pennsylvania State University, University Park, Pennsylvania, United States of America</addr-line></aff><aff id="aff012"><label>12</label><addr-line>University of Split School of Medicine, Split, Croatia</addr-line></aff><aff id="aff013"><label>13</label><addr-line>University of Osijek School of Medicine, Osijek, Croatia</addr-line></aff><aff id="aff014"><label>14</label><addr-line>Children's Hospital Srebrnjak, Zagreb, Croatia</addr-line></aff><aff id="aff015"><label>15</label><addr-line>PolyOmica, Groningen, The Netherlands</addr-line></aff><aff id="aff016"><label>16</label><addr-line>Carolinas Pain Institute, Winston-Salem, North Carolina, United States of America</addr-line></aff><contrib-group><contrib contrib-type="editor"><name><surname>Samartzis</surname><given-names>Dino</given-names></name><role>Editor</role><xref ref-type="aff" rid="edit1"></xref></contrib></contrib-group><aff id="edit1"><addr-line>University of Hong Kong, HONG KONG</addr-line></aff><author-notes><fn fn-type="COI-statement" id="coi001"><p><bold>Competing Interests: </bold>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 Grünenthal, 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.</p></fn><fn fn-type="con"><p><list list-type="simple"><list-item><p><bold>Conceptualization:</bold> CD MA MDG.</p></list-item><list-item><p><bold>Data curation:</bold> CD.</p></list-item><list-item><p><bold>Formal analysis:</bold> YA.</p></list-item><list-item><p><bold>Funding acquisition:</bold> MA.</p></list-item><list-item><p><bold>Investigation:</bold> CD.</p></list-item><list-item><p><bold>Methodology:</bold> CD MDG YA.</p></list-item><list-item><p><bold>Project administration:</bold> CD.</p></list-item><list-item><p><bold>Resources:</bold> CD MDG CG JM IG GL LD WW MS IKP JMD FW JVZ DP YA LK MA.</p></list-item><list-item><p><bold>Supervision:</bold> MA CG GL WW IKP FW JVZ DP.</p></list-item><list-item><p><bold>Validation:</bold> CD MDG CG JM IG GL IKP JMD.</p></list-item><list-item><p><bold>Visualization:</bold> CD MDG CG JM IG GL LD WW MS IKP JMD FW JVZ DP YA LK MA.</p></list-item><list-item><p><bold>Writing – original draft:</bold> CD.</p></list-item><list-item><p><bold>Writing – review & editing:</bold> CD MDG CG JM IG GL LD WW MS IKP JMD FW JVZ DP YA LK MA.</p></list-item></list></p></fn><fn fn-type="other" id="fn001"><p>¶ Membership of the PainOmics Group is provided in the Acknowledgments.</p></fn><corresp id="cor001">* E-mail: <email>cdagostino@parmanesthesia.com</email></corresp></author-notes><pub-date pub-type="epub"><day>1</day><month>5</month><year>2017</year></pub-date><pub-date pub-type="collection"><year>2017</year></pub-date><volume>12</volume><issue>5</issue><elocation-id>e0176372</elocation-id><history><date date-type="received"><day>12</day><month>7</month><year>2016</year></date><date date-type="accepted"><day>10</day><month>4</month><year>2017</year></date></history><permissions><copyright-statement>© 2017 Dagostino et al</copyright-statement><copyright-year>2017</copyright-year><copyright-holder>Dagostino et al</copyright-holder><license xlink:href="http://creativecommons.org/licenses/by/4.0/"><license-p>This is an open access article distributed under the terms of the <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">Creative Commons Attribution License</ext-link>, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.</license-p></license></permissions><self-uri content-type="pdf" xlink:href="pone.0176372.pdf"></self-uri><abstract><p>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 the Global Burden of Disease 2010 study.</p><p>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.</p><p>In this study, we validated an SOP model that will be used in the multicentre (5 centres) retrospective “PainOmics” 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.</p><p>The SOPs describe the specific procedures for (<italic>1</italic>) blood collection, (<italic>2</italic>) sample processing and storage, (<italic>3</italic>) shipping details and (<italic>4</italic>) cross-check testing and validation before assays that all the centres involved in the study have to follow.</p><p>Multivariate analysis revealed the absolute specificity and homogeneity of the samples collected by the five centres for all genetics, glycomics and activomics analyses.</p><p>The SOPs used in our multicenter study have been validated. Hence, they could represent an innovative tool for the correct management and collection of reliable samples in other large-omics-based multicenter studies.</p></abstract><funding-group><award-group id="award001"><funding-source><institution>Seventh Framework Program of the European Community for Research, Technological Development and Demonstration Activities - (FP7)</institution></funding-source><award-id>602736</award-id></award-group><funding-statement>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 “PainOmics” (Grant 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.</funding-statement></funding-group><counts><fig-count count="6"></fig-count><table-count count="1"></table-count><page-count count="13"></page-count></counts><custom-meta-group><custom-meta id="data-availability"><meta-name>Data Availability</meta-name><meta-value>All relevant data (figures, tables, legends and appendix) are within the paper and its Supporting Information files.</meta-value></custom-meta></custom-meta-group></article-meta><notes><title>Data Availability</title><p>All relevant data (figures, tables, legends and appendix) are within the paper and its Supporting Information files.</p></notes></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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