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

February 6, 2021 updated by: Assistance Publique - Hôpitaux de Paris
Exploration of pathophysiological mechanisms in chronic inflammatory rheumatism and rare systemic autoimmune diseases with the objective of identifying therapeutic targets.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Le Kremlin-Bicêtre, France, 94275
        • CHU Bicêtre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xavier Mariette, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the end of the study (5 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protein study (ELISA on serum) : IL7
Time Frame: At the end of the study (5 years)
levels of IL7 and other cytokines
At the end of the study (5 years)
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)
At the end of the study (5 years)
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
At the end of the study (5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: gaetane Nocturne, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2021

Primary Completion (ANTICIPATED)

March 1, 2026

Study Completion (ANTICIPATED)

March 1, 2026

Study Registration Dates

First Submitted

February 6, 2021

First Submitted That Met QC Criteria

February 6, 2021

First Posted (ACTUAL)

February 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 6, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP210093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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