Molecular Reclassification to Find Clinically Useful Biomarkers for Systemic Autoimmune Diseases: Case-control
NCT ID: NCT02890147
Last Updated: 2018-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
649 participants
OBSERVATIONAL
2014-12-31
2017-10-31
Brief Summary
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Detailed Description
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The specific objectives of this cross sectional study and sub-study are:
1. To identify a systemic taxonomy for patients with SADs by producing the following data in individuals with SADs and controls: genetic, epigenomic, transcriptomic, flow cytometric (from peripheral blood mononuclear and polymorphonuclear cells (PBMCs)), metabolomics and proteomic in plasma and urine, exosome analysis, classical serology (antibodies and autoantibodies), and clinical data.
2. To better characterize individual SADs at the omics level.
3. To perform clustering analyses to determine the groups of individuals who, differentially from other groups, share specific molecular features (precision medicine).
4. To identify gene expression, methylation profiles through deconvolution methods comparing a mixture of cells with subpopulations determined by flow cytometry with separated cells, cytokine profiles and plasma metabolomics using Mass Spectrometry, in a substudy of 288 individuals.
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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Signed the informed consent form
Exclusion Criteria
* Individuals suffering from any inflammatory, autoimmune, allergic or infectious condition and if possible without a history of autoimmune disease, particularly thyroid disease or other diseases that may modify cellular profiles in blood.
* Pregnant women.
18 Years
ALL
Yes
Sponsors
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UCB Biopharma S.P.R.L.
INDUSTRY
Atrys Health
INDUSTRY
National Research Council, Spain
OTHER_GOV
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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
Fundación Pública Andaluza Progreso y Salud
OTHER
Responsible Party
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Principal Investigators
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Marta Alarcon
Role: STUDY_DIRECTOR
Fundación Pública Andaluza Progreso y Salud (PHFSpain)
Locations
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Medical University of Vienna
Vienna, , Austria
UZ Leuven - KU Leuven, Department of Rheumatology (KU LEUVEN)
Leuven, , Belgium
CHRU de Brest
Brest, , 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
Countries
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Other Identifiers
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PRECISESADS-T
Identifier Type: -
Identifier Source: org_study_id
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