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Phenomics in Autoimmune and Inflammatory Diseases (TRANSIMMUNOM)

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ClinicalTrials.gov Identifier: NCT02466217
Recruitment Status : Recruiting
First Posted : June 9, 2015
Last Update Posted : December 13, 2016
Sponsor:
Collaborator:
National Research Agency, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date May 12, 2015
First Posted Date June 9, 2015
Last Update Posted Date December 13, 2016
Study Start Date July 2015
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 4, 2015)
  • Total peripheral blood gene expression between patients, expressed as fluorescence intensity [ Time Frame: at day 0, no follow-up ]
    Identification of novel molecular and cellular pathways involved either in specific diseases or across the IAD continuum through a multiparametric approach
  • Tregs and Tconvs T cell receptor repertoire, expressed as the % of unique TCR sequences [ Time Frame: at day 0, no follow-up ]
    Identification of novel molecular and cellular pathways involved either in specific diseases or across the IAD continuum through a multiparametric approach
  • HLA type and SNPs expressed as the occurrence events across patients [ Time Frame: at day 0, no follow-up ]
    Identification of novel molecular and cellular pathways involved either in specific diseases or across the IAD continuum through a multiparametric approach
  • Microbiote species identification expressed as the % of species per family and genus [ Time Frame: at day 0, no follow-up ]
    Identification of novel molecular and cellular pathways involved either in specific diseases or across the IAD continuum through a multiparametric approach
  • Cytokines and chemokines expressed as fluorescence intensity [ Time Frame: at day 0, no follow-up ]
    Identification of novel molecular and cellular pathways involved either in specific diseases or across the IAD continuum through a multiparametric approach
  • Immune cells phenotyping expressed as the each cell type % within total PBMCs [ Time Frame: at day 0, no follow-up ]
    Identification of novel molecular and cellular pathways involved either in specific diseases or across the IAD continuum through a multiparametric approach
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02466217 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 4, 2015)
  • Changes in gene expression intensity between patients and healthy controls - for each Disease cohorts [ Time Frame: at day 0, no follow-up ]
    Identification of new biomarkers and potential therapeutic by multiscale analysis
  • Changes in Tregs and Tconvs TCR sequence frequencies between patients and healthy controls - for each Disease cohorts [ Time Frame: at day 0, no follow-up ]
    Identification of new biomarkers and potential therapeutic by multiscale analysis
  • Characterization of HLA and SNP profiles in patients and healthy controls - for each Disease cohorts [ Time Frame: at day 0, no follow-up ]
    Identification of new biomarkers and potential therapeutic by multiscale analysis
  • Changes in Microbiote composition between patients and healthy controls - for each Disease cohorts [ Time Frame: at day 0, no follow-up ]
    Identification of new biomarkers and potential therapeutic by multiscale analysis
  • Changes in cytokines and chemokines expression levels between patients and healthy controls - for each Disease cohorts [ Time Frame: at day 0, no follow-up ]
    Identification of new biomarkers and potential therapeutic by multiscale analysis
  • Changes in immune cells frequencies between patients and healthy controls - for each Disease cohorts [ Time Frame: at day 0, no follow-up ]
    Identification of new biomarkers and potential therapeutic by multiscale analysis
  • Identification of specific and common gene expression levels between patients - between Disease cohorts [ Time Frame: at day 0, no follow-up ]
    Identification of new biomarkers and potential therapeutic by multiscale analysis
  • Identification of specific and common Tregs and Tconvs TCR sequence frequencies between patients - between Disease cohorts [ Time Frame: at day 0, no follow-up ]
    Identification of new biomarkers and potential therapeutic by multiscale analysis
  • Characterization of specific and common HLA and SNP profiles in patients - between Disease cohorts [ Time Frame: at day 0, no follow-up ]
    Identification of new biomarkers and potential therapeutic by multiscale analysis
  • Identification of specific and common microbiote composition between patients - between Disease cohorts [ Time Frame: at day 0, no follow-up ]
    Identification of new biomarkers and potential therapeutic by multiscale analysis
  • Identification of specific and common cytokines and chemokines expression levels between patients - between Disease cohorts [ Time Frame: at day 0, no follow-up ]
    Identification of new biomarkers and potential therapeutic by multiscale analysis
  • Characterization specific and common variations in immune cells frequencies between patients - between Disease cohorts [ Time Frame: at day 0, no follow-up ]
    Identification of new biomarkers and potential therapeutic by multiscale analysis
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Phenomics in Autoimmune and Inflammatory Diseases
Official Title Clinical and Multi-omics Cross-phenotyping of Patients With Autoimmune and Auto-inflammatory Diseases
Brief Summary The family of inflammatory/autoimmune systemic diseases (IAD) form a continuum from pure inflammatory diseases to pure autoimmune diseases, encompassing a large panel of inflammatory diseases with some autoimmune components, and vice versa. Cross phenotyping of patients with IAD should be heuristic and help revise the nosography and the understanding of these diseases.
Detailed Description

The family of inflammatory/autoimmune systemic diseases (IAD) represents a large group of human diseases. For most if not all of these IAD, the pathophysiological processes or exact causes remain poorly understood. Progresses in molecular understanding of these IAD have led to realize that these are not two distinct categories of diseases. Rather they form a continuum from pure inflammatory diseases to pure autoimmune diseases, encompassing a large panel of inflammatory diseases with some autoimmune components, and vice versa.

Using systems biology, the investigator aims to improve the understanding of these diseases, to identify novel genes/pathways involved, specific or across the diseases, and to discover biomarkers and potential therapeutic targets.

The investigator will study adult patients with at least one of the following IAD: Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus/Antiphospholipid Syndrome, Familial Mediterranean Fever (FMF), Cryopyrin-Associated Periodic Syndromes (CAPS) /Tumor Necrosis Factor-receptor Associated Periodic Syndrome (TRAPS), Vasculitis, Uveitis, Myositis, Crohn's Disease, Ulcerative colitis, Type 1 Diabetes. This panel will be completed by controls groups: healthy volunteers, and patients with arthritis (knee and/or hip) or muscular dystrophy.

The biological investigations will notably comprise: immunomics (comprehensive evaluation of peripheral blood cell subsets and serum immunoproteomics, including autoantibodies); transcriptomics; Human Leukocyte Antigen (HLA)-phenotyping; genomics; T-Cell Receptor (TCR) sequencing and microbiota studies.

After signing the informed consent, the subject attends only one visit (Day 0) during which all biological samples will be taken and all clinical information collected.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The investigator will study adult patients with at least one of the following IAD: Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus/Antiphospholipid Syndrome, FMF, Cryopyrin-Associated Periodic Syndromes (CAPS)/TNF-receptor Associated Periodic Syndrome (TRAPS), Vasculitis, Uveitis, Myositis, Crohn's Disease, Ulcerative colitis, Type 1 Diabetes. This panel will be completed by controls groups: healthy volunteers, and patients with arthritis (knee and/or hip) or muscular dystrophy
Condition
  • Healthy Volunteer
  • Rheumatoid Arthritis
  • Ankylosing Spondylitis
  • Systemic Lupus Erythematosus/Antiphospholipid Syndrome
  • FMF
  • Cryopyrin-Associated Periodic Syndromes /TNF-receptor Associated Periodic Syndrome
  • Vasculitis
  • Uveitis
  • Myositis
  • Crohn's Disease
  • Ulcerative Rectocolitis
  • Type 1 Diabetes
  • Unclassified IAD Knee and/or Hip Arthritis, Muscular Dystrophy
Intervention
  • Other: 1: AID groups
    Clinical and Biological investigations
  • Other: 2: Control groups
    Clinical and Biological investigations
Study Groups/Cohorts
  • 1: AID groups
    Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus/Antiphospholipid Syndrome, FMF, Cryopyrin-Associated Periodic Syndromes (CAPS)/TNF-receptor Associated Periodic Syndrome (TRAPS), Vasculitis, Uveitis, Myositis, Crohn's Disease, Ulcerative colitis, Type 1 Diabetes
    Intervention: Other: 1: AID groups
  • 2: Control groups
    knee arthritis, hip arthritis, muscular dystrophy, healthy subject
    Intervention: Other: 2: Control groups
Publications * Lorenzon R, Mariotti-Ferrandiz E, Aheng C, Ribet C, Toumi F, Pitoiset F, Chaara W, Derian N, Johanet C, Drakos I, Harris S, Amselem S, Berenbaum F, Benveniste O, Bodaghi B, Cacoub P, Grateau G, Amouyal C, Hartemann A, Saadoun D, Sellam J, Seksik P, Sokol H, Salem JE, Vicaut E, Six A, Rosenzwajg M, Bernard C, Klatzmann D. Clinical and multi-omics cross-phenotyping of patients with autoimmune and autoinflammatory diseases: the observational TRANSIMMUNOM protocol. BMJ Open. 2018 Aug 30;8(8):e021037. doi: 10.1136/bmjopen-2017-021037.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 4, 2015)
1300
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2021
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Presenting either:

    • one IAD from our list (Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus/Antiphospholipid Syndrome, FMF, Cryopyrin-Associated Periodic Syndromes (CAPS)/Tumor Necrosis Factor (TNF)-receptor Associated Periodic Syndrome, Vasculitis, Uveitis, Myositis, Crohn's Disease, Ulcerative colitis, Type 1 Diabetes)
    • or an unclassified IAD : a knee and/or hip arthritis or a muscular dystrophy
    • or healthy subject
  • Good veins
  • Affiliation to a social security system
  • Informed consent form, signed by the participant and the investigator, prior all needed examination

Exclusion Criteria:

  • For IADs patients

    • Unauthorized treatment (anticancer chemotherapy)
  • For Healthy volunteers

    • Contra-indications for donating blood except from age
    • Known history of IAD (eg: Psoriasis)
  • Common exclusion criteria:

    • Pregnant woman
    • Still under the exclusion period from another biomedical study
    • Psychiatric or addiction pathology who could interfere with the ability to fulfill the protocol needs or to provide an informed consent
    • Patient under a legal protection
    • Chronic lifelong viral infection unrelated to the pathology
    • Mild infection within the last 3 months
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: David KLATZMANN, MD, PhD 0033 1 42 17 74 61 david.klatzmann@upmc.fr
Contact: Roberta LORENZON, MD 33 1 42 17 85 33 roberta.lorenzon@upmc.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02466217
Other Study ID Numbers P141006
2015-A00558-41 ( Other Identifier: EUDRACT )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators National Research Agency, France
Investigators
Principal Investigator: David KLATZMANN, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date December 2016