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Study of Leukocyte Populations in Patients With Chronic Inflammatory (LIMA)

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ClinicalTrials.gov Identifier: NCT04749875
Recruitment Status : Not yet recruiting
First Posted : February 11, 2021
Last Update Posted : February 11, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
Exploration of pathophysiological mechanisms in chronic inflammatory rheumatism and rare systemic autoimmune diseases with the objective of identifying therapeutic targets.

Condition or disease Intervention/treatment
Systemic Autoimmune Disease Chronic Inflammatory Rheumatism Sjogren's Syndrome Spondyloarthritis Rheumatoid Arthritis Systemic Lupus Erythematosus Other: blood sample

Detailed Description:
The primary objective is to characterization of the quantitative and qualitative specificities of the different leukocyte sub-populations in patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases. We will perform an exploratory descriptive study whom primary endpoint will be to assess by FACS the phenotype of the specific leukocyte subsets. In addition, we will characterize the protein and transcriptomic signature associated with the conditions for which we have obtained preliminary data showing their potential involvement in autoimmunity (i.e: IL7 pathway, IFN signature).
Study Design
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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Leukocyte Populations in Patients With Chronic Inflammatory
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : March 1, 2026
Estimated Study Completion Date : March 1, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: blood sample
    sampling of blood for research during routine care

Outcome Measures
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Primary Outcome Measures :
  1. Characterization of the quantitative and qualitative specificities of the different leukocyte subpopulations in patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases [ Time Frame: At the end of the study (5 years) ]
    Proportion of different leukocytes subset


Secondary Outcome Measures :
  1. Protein study (ELISA on serum) : IL7 [ Time Frame: At the end of the study (5 years) ]
    levels of IL7 and other cytokines

  2. Transcriptome study (RNA) : mRNA levels [ Time Frame: At the end of the study (5 years) ]
    assessement of different mRRNA involved in Il7/IFN pathways by molecular biology techniques (RNAseq, qPCR, nano string)

  3. Genomic study (DNA) : SNPs [ Time Frame: At the end of the study (5 years) ]
    Determination of the genotype of different SNPs involved in IL7/IFN pathways


Biospecimen Retention:   Samples Without DNA
whole blood, serum,

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Patient who did not express his opposition
  • Patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases (pSS, lupus, scleroderma, myositis, unclassified connectivitis) diagnosed according to the usual criteria.
  • Weight> 35 kg

Exclusion Criteria:

  • Corticosteroid treatment> 10 mg / day
  • Pregnant patient
  • Patients under legal protection
  • Beneficiary of the state medical aid
Contacts and Locations
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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): NCT04749875


Contacts
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Contact: Xavier MARIETTE 00 33 1 45 21 37 58 xavier.mariette@aphp.fr

Locations
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France
CHU Bicêtre
Le Kremlin-Bicêtre, France, 94275
Contact: Xavier Mariette, MD, PhD    +33 (0)1 45 21 37 51    xavier.mariette@bct.aphp.fr   
Contact: Gaetane Nocturne, MCU-PH    0033 1 45 21 37 57    gaetane.nocturne@aphp.fr   
Principal Investigator: Xavier Mariette, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Gaetane Nocturne APHP
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04749875    
Other Study ID Numbers: APHP210093
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
leukocytes
macrophages
lymphocytes
rare systemic autoimmune diseases
chronic inflammatory rheumatism
Additional relevant MeSH terms:
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Rheumatic Fever
Sjogren's Syndrome
Rheumatic Diseases
Lupus Erythematosus, Systemic
Collagen Diseases
Autoimmune Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
Connective Tissue Diseases
Immune System Diseases
 Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses