Immun4Cure Cohort of Autoimmune Diseases

N/ANot Yet RecruitingNCT07515638

University Hospital, Montpellier500 enrolled

Overview

This prospective cohort study aims to constitute a 500-participant database and biobank including 450 adults with systemic autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis) and 50 healthy controls.

The Immun4Cure Cohort is a monocentric prospective cohort conducted at Montpellier University Hospital. Autoimmune diseases (AIDs) are complex, heterogeneous conditions involving dysregulation of innate and adaptive immunity, chronic inflammation, and irreversible tissue damage. The three targeted diseases-rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and systemic sclerosis (SSc represent major public-health challenges due to their severity, treatment burden, and impact on quality of life. The study integrates standardized longitudinal clinical follow-up over 5 years, deep phenotyping, multi-omic analyses (genomics, transcriptomics, proteomics, metabolomics, immunophenotyping), environmental exposure assessment, and biological sample collection (blood, serum, plasma, PBMCs, urine, stool, saliva, optional tissue biopsies). Healthy subjects undergo baseline and 12-month evaluations to establish reference immune, metabolic, and environmental signatures. This cohort will serve as a foundational research platform for translational studies and ancillary projects on autoimmune diseases.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Rheumatoid Arthritis Systemic Lupus Erythematosus Systemic Sclerosis Healthy Adult Volunteers

Interventions

Blood test and principal collectionBIOLOGICAL

A total of 62.5 mL of blood will be collected while fasting, using the following tubes: * one 2.5 mL PAXGene Blood RNA Tube * seven 6mL heparinised Tubes * two 6mL EDTA Tubes * one 6mL dry Tube As part of routine care for groups 1, 2, and 3, and specific to research for group 4: A biological research assessment (urine and blood): complete blood count, platelets, HbA1c, reticulocytes, schizocytes, haptoglobin, ionogram, troponin, NT-proBNP, calcium, CRP, creatinine, GFR, uric acid, ferritin, CPK, fasting blood glucose, albumin, serum protein electrophoresis, total bilirubin, γGT, ASAT, ALAT, PAL, TSH, total cholesterol, LDL, HDL, triglycerides, B9, B12, HBV, HCV, HIV, CMV, EBV serology, antinuclear antibodies, DNA, ACPA, rheumatoid factor, C3, C4, proteinuria/creatininuria, urine strip test

Optional collectionBIOLOGICAL

The optional collection will include: * stool sample (50 mL) * urine sample (50 mL) * saliva sample (2 mL)

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria Participants: Group 1: RA * Adults ≥18 years * Patient followed as part of their MAI in one of the departments participating in the study at UHM * Confirmed diagnosis according to international criteria :ACR/EULAR 2010 Group 2: LES * Adults ≥18 years * Patient followed as part of their MAI in one of the departments participating in the study at UHM * Confirmed diagnosis according to international criteria :ACR/EULAR 2019 Group 3: SSc * Adults ≥18 years * Patient followed as part of their MAI in one of the departments participating in the study at UHM * Confirmed diagnosis according to international criteria :ACR/EULAR 2013 Group 4: Healthy Controls * Adults ≥18 years * No symptoms of autoimmune disease * No first-degree family history of autoimmune disease Exclusion Criteria (all groupes): * Patients who have refused or are unable to give informed consent * Inability to follow the subject during the study period * Participation in another interventional study that includes an exclusion period that is still ongoing * Pregnant women * Not affiliated with a social security scheme * Patients without a national insurance number * Persons under judicial protection, guardianship or trusteeship * Persons deprived of their liberty

Outcomes

Primary Outcomes

AUC-ROC discriminant performance of multi-omic biomarkers

Discriminatory power (AUC-ROC) of biological markers measured using a multi-omic approach (genomics, proteomics, transcriptomics, epitranscriptomics, immunology, metabolomics) common to adult patients with autoimmune disease (AID), compared to adults without AID.

Time frame: Baseline to 60 months

Secondary Outcomes

Characterization of Pathophysiological Mechanisms Through Multi-Omic and Spatial Immune Profiling

Immune signatures from blood and tissue samples (including synovial, skin, and other available biopsies) will be analyzed to determine disease-specific patterns and their discriminative capacity across autoimmune diseases. Immune cells, particularly macrophages, will be isolated and profiled using single-cell-based spatial analyses. Samples will undergo multi-omic characterization, including proteomic, transcriptomic, epitranscriptomic, immunological, and metabolomic analyses, to identify disease-specific molecular and cellular signatures.

Time frame: Baseline, disease flare (if applicable), and end of follow-up (Month 60)

Central Contacts

Charlotte KAAN

CONTACT

+334 67 33 48 53 depotac@chu-montpellier.fr

Data from ClinicalTrials.gov

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