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| Name | Class |
|---|---|
| UCB Biopharma S.P.R.L. | INDUSTRY |
| Atrys Health | INDUSTRY |
| National Research Council, Spain | OTHER_GOV |
| Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
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Connective tissue diseases (CTD) or systemic autoimmune diseases (SADs) as they are known today are a group of chronic inflammatory conditions with autoimmune aetiology with few treatment options and difficult diagnosis.Brest team contribute to perform a new classification of the following systemic autoimmune diseases in a European Union's Seventh Framework Programme. The aim of this research is to constitute a Healthy Volunteers cohort to compare with systemic autoimmune diseases cohort into molecular clusters instead of clinical entities through the determination of molecular profiles using several "Omics" techniques.
The main objective of the PRECISESADS project is to reclassify the individuals affected by SADs into molecular clusters instead of clinical entities through the determination of molecular profiles using several "-omics" techniques.
The specific objectives of this cross sectional study and sub-study are:
The clustering process will be data-driven with the aim to find the most homogenous and differentiated clusters of diseases that clearly separate individuals on the basis of, serological, genetic, epigenomic, cellular (cell proportions), metabolomic, proteomic (cytokines, autoantibodies) and transcriptome characteristics and differentiate them from controls and other patient clusters.
A total of 2000 patients and 666 controls will be included in the study.
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| Measure | Description | Time Frame |
|---|---|---|
| Gene expression in total blood | Gene expression will be done using commercial gene expression microarrays in total blood from all samples using the RNA Paxgene tube. | 2 years |
| Flow cytometry analysis to determine cell proportions in the total blood mixture in all individuals. | 9 optimized panels of antibodies will be used to determine cell subpopulations in peripheral blood (including very minor cell populations). | 24 hours |
| Genotyping | Genotyping will be done using a whole genome array. | 2 years |
| Metabolite determination | Metabolite determination in plasma and urine using Nuclear Magnetic Resonance | 2 years |
| Exosome isolation from plasma and urine | set up of the methodology for isolating exosomes in these bodily fluids for gene expression analysis | 2 years |
| Cytokine profile determination | 88 different cytokines will be assessed with Luminex | 2 years |
| routine autoantibodies in serum | set of serum autoantibodies will be determined in a European validated laboratory. Also, they will perform detection of antibodies against small lipid moieties i.e.antiphosphorylcholine), lupus anticoagulant and complement proteins in plasma. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy Volunteers
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| Name | Affiliation | Role |
|---|---|---|
| Marta Alarcon | Fundación Pública Andaluza Progreso y Salud (PHFSpain) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | Austria | ||||
| UZ Leuven - KU Leuven, Department of Rheumatology (KU LEUVEN) |
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| OTHER |
| Servicio Cántabro de Salud | OTHER |
| August Pi Sunyer Biomedical Research Institute | OTHER |
| Karolinska Institutet | OTHER |
| KU Leuven | OTHER |
| Klinikum der Universität Köln | OTHER |
| Hannover Medical School | OTHER |
| Medical University of Vienna | OTHER |
| Quartz Bio S.A. | OTHER |
| Andaluz Health Service | OTHER_GOV |
| The Cyprus Foundation for Muscular Dystrophy Research | OTHER |
| Universidad de Granada | OTHER |
| University of Milan | OTHER |
| Université Catholique de Louvain | OTHER |
| University Hospital, Brest | OTHER |
| University of Geneva, Switzerland | OTHER |
| Szeged University | OTHER |
| Bayer | INDUSTRY |
| Institut de Recherches Internationales Servier | OTHER |
| Sanofi | INDUSTRY |
| Eli Lilly and Company | INDUSTRY |
| Charite University, Berlin, Germany | OTHER |
| Centro Hospitalar do Porto | OTHER |
| Institut d'Investigació Biomèdica de Bellvitge | OTHER |
| Innovative Medicines Initiative | OTHER |
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Blood and urine
| Gene expression methylation in total blood | Methylation analysis will be done using the methylome 450k array using the DNA obtained from total blood. MicroRNA gene expression arrays using total blood. | 2 years |
| Leuven |
| Belgium |
| CHRU de Brest | Brest | 29609 | France |
| Deutsches Rheuma-Forschungszentrum Berlin (DRFZ) | Berlin | Germany |
| Medizinische Hochschule Hannover | Hanover | Germany |
| University of Szeged | Szeged | Hungary |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico (IRCCS) | Milan | Italy |
| UNIMI, Istituto Ortopedico Getano Pini | Milan | Italy |
| Centro Hospitalar do Porto | Porto | Portugal |
| Hospital Clinic I Provicia- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) | Barcelona | Spain |
| Hospital Universitario Reina Sofía Andaluz de Salud | Córdoba | Spain |
| Biobanco del Sistema Sanitario Público de Andalucía (SSPA) | Granada | Spain |
| Hospital Universitario San Cecilio Servicio Andaluz de Salud | Granada | Spain |
| Hospital Virgen de las Nieves Granada | Granada | Spain |
| Hospital Regional de Málaga Servicio Andaluz de Salud | Málaga | Spain |
| Hospital Universitario Marqués de Valdecilla, Servicio Cántabro de Salud | Santander | Spain |
| Hospitaux Universitaires de Géneve | Geneva | Switzerland |