Study of Leukocyte Populations in Patients With Chronic Inflammatory

NCT04749875 | Not Yet Recruiting

• 1 other identifier: APHP210093
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Systemic Autoimmune Disease; Chronic Inflammatory Rheumatism; Sjogren's Syndrome; Spondyloarthritis; Rheumatoid Arthritis; Systemic Lupus Erythematosus

Keywords

leukocytes; macrophages; lymphocytes; rare systemic autoimmune diseases; chronic inflammatory rheumatism

Outcome Measures

Primary Outcomes (1)

• Characterization of the quantitative and qualitative specificities of the different leukocyte subpopulations in patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases

  Proportion of different leukocytes subset

  At the end of the study (5 years)

Secondary Outcomes (3)

• Protein study (ELISA on serum) : IL7

  At the end of the study (5 years)

• Transcriptome study (RNA) : mRNA levels

  At the end of the study (5 years)

• Genomic study (DNA) : SNPs

  At the end of the study (5 years)

Interventions

blood sample OTHER

sampling of blood for research during routine care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases

You may qualify if:

• 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

You may not qualify if:

• Corticosteroid treatment\> 10 mg / day
• Pregnant patient
• Patients under legal protection
• Beneficiary of the state medical aid

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

CHU Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, serum,

MeSH Terms

Conditions

Sjogren's Syndrome; Spondylarthritis; Arthritis, Rheumatoid; Lupus Erythematosus, Systemic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylitis; Spinal Diseases; Bone Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Gaetane Nocturne

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xavier MARIETTE

CONTACT

00 33 1 45 21 37 58; xavier.mariette@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: February 6, 2021
• First Posted: February 11, 2021
• Study Start: March 1, 2021
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)