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Molecular Reclassification to Find Clinically Useful Biomarkers for Systemic Autoimmune Diseases: Case-control (PRECISESADST)

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ClinicalTrials.gov Identifier: NCT02890147
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : May 23, 2018
Sponsor:
Collaborators:
UCB Biopharma S.P.R.L.
Atrys Health
National Research Council, Spain
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Servicio Cántabro de Salud
August Pi Sunyer Biomedical Research Institute
Karolinska Institutet
KU Leuven
Klinikum der Universität Köln
Hannover Medical School
Medical University of Vienna
Quartz Bio S.A.
Andaluz Health Service
The Cyprus Foundation for Muscular Dystrophy Research
Universidad de Granada
University of Milan
Université Catholique de Louvain
University Hospital, Brest
University of Geneva, Switzerland
Szeged University
Bayer
Institut de Recherches Internationales Servier
Sanofi
Eli Lilly and Company
Charite University, Berlin, Germany
Centro Hospitalar do Porto
Institut d'Investigació Biomèdica de Bellvitge
Innovative Medicines Initiative
Information provided by (Responsible Party):
Andalusian Network for Design and Translation of Advanced Therapies ( Fundación Pública Andaluza Progreso y Salud )

Brief Summary:
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.

Condition or disease
Healthy Subjects

Detailed Description:

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:

  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.

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Study Type : Observational
Actual Enrollment : 649 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Reclassification to Find Clinically Useful Biomarkers for Systemic Autoimmune Diseases: Case-control
Actual Study Start Date : December 2014
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Gene expression in total blood [ Time Frame: 2 years ]
    Gene expression will be done using commercial gene expression microarrays in total blood from all samples using the RNA Paxgene tube.

  2. Flow cytometry analysis to determine cell proportions in the total blood mixture in all individuals. [ Time Frame: 24 hours ]
    9 optimized panels of antibodies will be used to determine cell subpopulations in peripheral blood (including very minor cell populations).

  3. Genotyping [ Time Frame: 2 years ]
    Genotyping will be done using a whole genome array.

  4. Metabolite determination [ Time Frame: 2 years ]
    Metabolite determination in plasma and urine using Nuclear Magnetic Resonance

  5. Exosome isolation from plasma and urine [ Time Frame: 2 years ]
    set up of the methodology for isolating exosomes in these bodily fluids for gene expression analysis

  6. Cytokine profile determination [ Time Frame: 2 years ]
    88 different cytokines will be assessed with Luminex

  7. routine autoantibodies in serum [ Time Frame: 2 years ]
    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.

  8. Gene expression methylation in total blood [ Time Frame: 2 years ]
    Methylation analysis will be done using the methylome 450k array using the DNA obtained from total blood. MicroRNA gene expression arrays using total blood.


Biospecimen Retention:   Samples With DNA
Blood and urine


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy Volunteers
Criteria

Inclusion Criteria:

  • Aged 18 years or older at the time of consent
  • Signed the informed consent form

Exclusion Criteria:

  • Individuals on chronic medication.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890147


Locations
Show Show 17 study locations
Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud
UCB Biopharma S.P.R.L.
Atrys Health
National Research Council, Spain
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Servicio Cántabro de Salud
August Pi Sunyer Biomedical Research Institute
Karolinska Institutet
KU Leuven
Klinikum der Universität Köln
Hannover Medical School
Medical University of Vienna
Quartz Bio S.A.
Andaluz Health Service
The Cyprus Foundation for Muscular Dystrophy Research
Universidad de Granada
University of Milan
Université Catholique de Louvain
University Hospital, Brest
University of Geneva, Switzerland
Szeged University
Bayer
Institut de Recherches Internationales Servier
Sanofi
Eli Lilly and Company
Charite University, Berlin, Germany
Centro Hospitalar do Porto
Institut d'Investigació Biomèdica de Bellvitge
Innovative Medicines Initiative
Investigators
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Study Director: Marta Alarcon Fundación Pública Andaluza Progreso y Salud (PHFSpain)
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Responsible Party: Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT02890147    
Other Study ID Numbers: PRECISESADS-T
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Andalusian Network for Design and Translation of Advanced Therapies ( Fundación Pública Andaluza Progreso y Salud ):
SADs
Healthy Volunteers
Molecular profiles
Omics Techniques
Additional relevant MeSH terms:
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Autoimmune Diseases
Immune System Diseases