Systemic Autoimmune DiseasesPRECISESADSNCT02890121
Molecular Reclassification to Find Clinically Useful Biomarkers for Systemic Autoimmune Diseases:
An observational study of Systemic Autoimmune Diseases, run by Fundación Pública Andaluza Progreso y Salud at 18 sites in 9 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Autoimmune Diseases
- How many people
- 2,006 participants
- Where
- 18 sitesin 9 countries
- Study dates
- Dec 2014to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with systemic autoimmune diseases
Who may be able to join
- · Aged 18 years or older at the time of consent
- Diagnosed according to prevailing criteria for one of the following systemic autoimmune diseases (see Annex 2)
- Rheumatoid arthritis (RA)
- Scleroderma or systemic sclerosis (SSc)
- Primary Sjögren's syndrome (SjS)
- Systemic lupus erythematosus (SLE)
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- Primary antiphospholipid syndrome (PAPS)
- Mixed Connective Tissue Disease (MCTD)
- Patients with undifferentiated connective tissue disease (UCTD) for over 1 year and that do not fulfill the diagnosis of any of the above diseases.
- Signed the informed consent form
Who cannot join
- · Patients unable to understand the procedures related to the protocol should not be included. The study is voluntary and patients must be able to give their informed consent.
- Pregnant women
- Neonatal lupus
- Drug-induced lupus
- Patients whose condition is so serious that they cannot take part in the study
- Severe nephrotic syndrome with proteinuria >=3,5 g/day
Show all 18Show fewer
- Patients with stable doses of steroids >15mg/day for the last 3 months or with IV corticosteroids in the last 3 months
- Patients under immunosuppressants for the last 3 months prior to recruitment with:
- Methotrexate ≥25mg/week
- Azathioprine ≥2.5mg/kg/day
- Cyclosporine A > 3mg/kg/day
- Mycophenolate Mofetil > 2gr/day
- Treatment with cyclophosphamide (any dose or route of administration) or Belimumab in the past 6 months
- Patients with combined therapy of two or more immunosuppressants
- Patients on depletive therapy such as Rituximab in the last year
- Patients receiving experimental therapy.
- Chronic HBV or HCV infection
- Overlap syndromes
Trial locations and contacts
18 sites in 9 countries.
18 sites in 9 countries
Spain6 sites
Hospital Clinic I Provicia- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)
Barcelona
Hospital Universitario Reina Sofía Andaluz de Salud
Córdoba
Hospital Universitario San Cecilio Servicio Andaluz de Salud
Granada
Hospital Virgen de las Nieves Granada
Granada
Hospital Regional de Málaga Servicio Andaluz de Salud
Málaga
Hospital Universitario Marqués de Valdecilla, Servicio Cántabro de Salud
Santander
Germany3 sites
Deutsches Rheuma-Forschungszentrum Berlin (DRFZ)
Berlin
University of Cologne
Cologne
Medizinische Hochschule Hannover
Hanover
Belgium2 sites
Université catholique de Louvain - Cliniques Universitaires Saint-Luc
Brussels
UZ Leuven - KU Leuven, Department of Rheumatology (KU LEUVEN)
Leuven
Italy2 sites
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico (IRCCS)
Milan
UNIMI, Istituto Ortopedico Getano Pini
Milan
About this study
Official title: Molecular Reclassification to Find Clinically Useful Biomarkers for Systemic Autoimmune Diseases: Cross Sectional Cohort
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.
Read the 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:
- 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.
- To better characterize individual SADs at the omics level.
- To perform clustering analyses to determine the groups of individuals who, differentially from other groups, share specific molecular features (precision medicine).
- 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, adjusted to the following distribution:
- A total of 400 patients diagnosed with systemic lupus erythematosus (SLE)
- A total of 400 patients diagnosed with rheumatoid arthritis (RA)
- A total of 400 patients diagnosed of scleroderma or systemic sclerosis (SSc)
- A total of 400 patients diagnosed of Sjögren's syndrome (SjS)
- A total of 400 patients diagnosed of primary antiphospholipid syndrome (PAPS) or Mixed Connective Tissue Disease (MCTD) or with undifferentiated disease • All patients will be recruited from 18 sites in Europe (Austria, Belgium, France, Germany, Italy, Portugal, Spain, Hungary and Switzerland).
- Conditions
- Systemic Autoimmune Diseases
- Keywords
- SADs, Molecular Reclassification
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 24 hours
Genotyping
Genotyping will be done using a whole genome array
Measured: 2 years
Metabolite determination
Metabolite determination in plasma and urine using Nuclear Magnetic Resonance
Measured: 2 years
Exosome isolation from plasma and urine
set up of the methodology for isolating exosomes in these bodily fluids for gene expression analysis
Measured: 2 years
Cytokine profile determination
88 different cytokines will be assessed with Luminex
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startDec 2014
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Autoimmune DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,006 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Marta Alarcon, Study director, Fundación Pública Andaluza Progreso y Salud (PHFSpain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890121
- Sponsor's protocol ID
- PRECISESADS CS (RB 14.106)
- Acronym
- PRECISESADS
- Status last verified
- Apr 2018
- First submitted
- 22 Aug 2016
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Reclassification to Find Clinically Useful Biomarkers for Systemic Autoimmune Diseases: Cross Sectional Cohort
- ClinicalTrials.gov ID
- NCT02890121
- Acronym / sponsor ID
- PRECISESADS / PRECISESADS CS (RB 14.106)
- Conditions
- Systemic Autoimmune Diseases
- Keywords
- SADs, Molecular Reclassification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,006 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- 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
- Study start
- Dec 2014 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- To better characterize individual SADs at the omics level.
- To perform clustering analyses to determine the groups of individuals who, differentially from other groups, share specific molecular features (precision medicine).
- 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, adjusted to the following distribution:
- A total of 400 patients diagnosed with systemic lupus erythematosus (SLE)
- A total of 400 patients diagnosed with rheumatoid arthritis (RA)
- A total of 400 patients diagnosed of scleroderma or systemic sclerosis (SSc)
- A total of 400 patients diagnosed of Sjögren's syndrome (SjS)
- A total of 400 patients diagnosed of primary antiphospholipid syndrome (PAPS) or Mixed Connective Tissue Disease (MCTD) or with undifferentiated disease • All patients will be recruited from 18 sites in Europe (Austria, Belgium, France, Germany, Italy, Portugal, Spain, Hungary and Switzerland).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with systemic autoimmune diseases
Key inclusion criteria (10 listed)
- · Aged 18 years or older at the time of consent
Key exclusion criteria (18 listed)
- · Patients unable to understand the procedures related to the protocol should not be included. The study is voluntary and patients must be able to give their informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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).
Genotyping
Time frame: 2 years
Genotyping will be done using a whole genome array
Metabolite determination
Time frame: 2 years
Metabolite determination in plasma and urine using Nuclear Magnetic Resonance
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
Cytokine profile determination
Time frame: 2 years
88 different cytokines will be assessed with Luminex
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.
Gene 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Alarcon study director
Fundación Pública Andaluza Progreso y Salud (PHFSpain)
18 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Autoimmune Diseases, run by Fundación Pública Andaluza Progreso y Salud at 18 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Spain, Germany, Belgium, Italy, Austria and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression in total blood (time frame: 2 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2018.