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| ID | Type | Description | Link |
|---|---|---|---|
| IdRCB | Registry Identifier | 2024-A02838-39 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1-Rheumatoid arthritis (RA) | Adults aged 18 years or older with a diagnosis of rheumatoid arthritis meeting the 2010 ACR/EULAR classification criteria |
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| Group 2-Systemic lupus erythematosus (SLE) | Adults aged 18 years or older with a diagnosis of systemic lupus erythematosus meeting the 2019 ACR/EULAR classification criteria |
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| Group 3-Systemic sclerosis (SSc) | Adults aged 18 years or older with a diagnosis of systemic sclerosis meeting the 2013 ACR/EULAR classification criteria |
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| Group 4-Healthy adult volunteers (controls) [2024-A0283...Immun4Cure | PDF] | Adults aged 18 years or older with no symptoms suggestive of autoimmune disease and no first-degree family history of confirmed autoimmune disease |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood test and principal collection | Biological | A total of 62.5 mL of blood will be collected while fasting, using the following tubes:
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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria Participants:
Group 1: RA
Group 2: LES
Group 3: SSc
Group 4: Healthy Controls
Exclusion Criteria (all groupes):
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The study population includes 450 adults with autoimmune diseases: 150 with rheumatoid arthritis, 150 with systemic lupus erythematosus, and 150 with systemic sclerosis, diagnosed according to international classification criteria and followed within participating clinical departments at Montpellier University Hospital. An additional 50 healthy adults without autoimmune symptoms or first-degree family history of autoimmune disease serve as controls
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlotte KAAN | Contact | +334 67 33 48 53 | 33 | depotac@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Yves-Marie PERS, Pr | Montpellier University Hospital | Study Director |
| Edouard TUAILLON, Pr | Montpellier University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Montpellier - CIMA | Recruiting | Montpellier | France |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D008180 | Lupus Erythematosus, Systemic |
| D012595 | Scleroderma, Systemic |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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BLOOD COLLECTION: A total of 62.5 mL/participant.
Optional tissue samples:
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| Optional collection | Biological | The optional collection will include:
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| Patient questionnaires | Other | For groups 1 to 3 : Self-questionnaires will assess factors such as medical history, comorbidity exposure to toxic substances, occupational exposures, psychological and clinical factors. occupation and household income, as well as lifestyle habits (tobacco and alcohol consumption, possible drug use, sexual activity). Anxiety and depression environmental factors throughout life (diet, physical activity, sleep, contraception, sun exposure, pollution, noise, proximity to green spaces, etc.), 3-day food diary For group 4: Self-questionnaires will assess factors such comorbidity exposure to toxic substances, occupational exposures, psychological and clinical factors. occupation and household income, as well as lifestyle habits (tobacco and alcohol consumption, possible drug use, sexual activity). Anxiety and depression environmental factors throughout life (diet, physical activity, sleep, contraception, sun exposure, pollution, noise, proximity to green spaces, etc.), 3-day food diary |
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| Examination | Other | Group 1-RA: Capillaroscopy and optionnal Synovial microbiopsy Group 2-SLE: Optical coherence tomography (OCT) and optionnal skin biopsy and optionnal capillaroscopy Group 3-SSc: Capillaroscopy and optionnal skin biopsy Group 4: Optical coherence tomography (OCT) and capillaroscopie. Optionnal skin biopsy and optionnal Synovial microbiopsy |
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| Baseline, disease flare (if applicable), and end of follow-up (Month 60) |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
| D012871 | Skin Diseases |
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |