NCT02890147

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
649

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Typical duration for all trials

Geographic Reach
9 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

May 23, 2018

Status Verified

April 1, 2018

Enrollment Period

2.8 years

First QC Date

August 22, 2016

Last Update Submit

May 22, 2018

Conditions

Healthy Subjects

Keywords

SADsHealthy VolunteersMolecular profilesOmics Techniques

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy Volunteers

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Medical University of Vienna

Vienna, Austria

Location

UZ Leuven - KU Leuven, Department of Rheumatology (KU LEUVEN)

Leuven, Belgium

Location

CHRU de Brest

Brest, 29609, France

Location

Deutsches Rheuma-Forschungszentrum Berlin (DRFZ)

Berlin, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

University of Szeged

Szeged, Hungary

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico (IRCCS)

Milan, Italy

Location

UNIMI, Istituto Ortopedico Getano Pini

Milan, Italy

Location

Centro Hospitalar do Porto

Porto, Portugal

Location

Hospital Clinic I Provicia- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)

Barcelona, Spain

Location

Hospital Universitario Reina Sofía Andaluz de Salud

Córdoba, Spain

Location

Biobanco del Sistema Sanitario Público de Andalucía (SSPA)

Granada, Spain

Location

Hospital Universitario San Cecilio Servicio Andaluz de Salud

Granada, Spain

Location

Hospital Virgen de las Nieves Granada

Granada, Spain

Location

Hospital Regional de Málaga Servicio Andaluz de Salud

Málaga, Spain

Location

Hospital Universitario Marqués de Valdecilla, Servicio Cántabro de Salud

Santander, Spain

Location

Hospitaux Universitaires de Géneve

Geneva, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine

Study Officials

  • Marta Alarcon

    Fundación Pública Andaluza Progreso y Salud (PHFSpain)

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2016

First Posted

September 7, 2016

Study Start

December 1, 2014

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

May 23, 2018

Record last verified: 2018-04

Locations

DE(2)HU(1)IT(2)FR(1)BE(1)AU(1)CH(1)PT(1)ES(7)