NCT02890121|CompletedDMC
Molecular Reclassification to Find Clinically Useful Biomarkers for Systemic Autoimmune Diseases:
PRECISESADS
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PRECISESADS
Sponsor study identifier
observational
2,006
9 countries
18
Study Start
December 2014
Actual (reported)Primary Completion
October 2017
Actual (reported)Study Completion
October 2017
Actual (reported)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 reclassify the individuals affected by SADs into molecular clusters instead of clinical entities through the determination of molecular profiles using several "Omics" techniques.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2014
Actual (reported)August 22, 2016
Actual (reported)September 7, 2016
Actual (reported)October 2017
Actual (reported)October 2017
Actual (reported)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
Patient with systemic autoimmune diseases
Medical University of Vienna
Vienna, Austria
Université catholique de Louvain - Cliniques Universitaires Saint-Luc
Brussels, Belgium
UZ Leuven - KU Leuven, Department of Rheumatology (KU LEUVEN)
Leuven, Belgium
CHRU de Brest
Brest, 29609, France
Deutsches Rheuma-Forschungszentrum Berlin (DRFZ)
Berlin, Germany
University of Cologne
Cologne, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Blood and urine
Marta Alarcon
Fundación Pública Andaluza Progreso y Salud (PHFSpain)
2,006 participants (actual enrollment reported by the registry).
First Submitted
August 22, 2016
First Posted
September 7, 2016
Study Start
December 2014
Actual (reported)A Study of Azacitidine in Myelodysplastic Syndrome (MDS) Associated to Systemic Auto-immune and Inflammatory Disorders
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
Gene 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
Contact the study team to confirm eligibility.
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
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
Primary Completion
October 2017
Actual (reported)Study Completion
October 2017
Actual (reported)Last Updated
May 23, 2018
Record last verified: 2018-04
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Source: ClinicalTrials.gov.
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