Prospective Cohort Study of Clinical and Biological Data in Patients With Autoimmune Diseases (Immun4Cure Cohort)
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 500
- Primary Endpoint
- AUC-ROC discriminant performance of multi-omic biomarkers
Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
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
Arms & Interventions
Group 1-Rheumatoid arthritis (RA)
Adults aged 18 years or older with a diagnosis of rheumatoid arthritis meeting the 2010 ACR/EULAR classification criteria
Intervention: Optional collection (Biological)
Group 1-Rheumatoid arthritis (RA)
Adults aged 18 years or older with a diagnosis of rheumatoid arthritis meeting the 2010 ACR/EULAR classification criteria
Intervention: Examination (Other)
Group 1-Rheumatoid arthritis (RA)
Adults aged 18 years or older with a diagnosis of rheumatoid arthritis meeting the 2010 ACR/EULAR classification criteria
Intervention: Blood test and principal collection (Biological)
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
Intervention: Optional collection (Biological)
Group 3-Systemic sclerosis (SSc)
Adults aged 18 years or older with a diagnosis of systemic sclerosis meeting the 2013 ACR/EULAR classification criteria
Intervention: Optional collection (Biological)
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
Intervention: Examination (Other)
Group 1-Rheumatoid arthritis (RA)
Adults aged 18 years or older with a diagnosis of rheumatoid arthritis meeting the 2010 ACR/EULAR classification criteria
Intervention: Patient questionnaires (Other)
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
Intervention: Blood test and principal collection (Biological)
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
Intervention: Patient questionnaires (Other)
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
Intervention: Examination (Other)
Group 3-Systemic sclerosis (SSc)
Adults aged 18 years or older with a diagnosis of systemic sclerosis meeting the 2013 ACR/EULAR classification criteria
Intervention: Blood test and principal collection (Biological)
Group 3-Systemic sclerosis (SSc)
Adults aged 18 years or older with a diagnosis of systemic sclerosis meeting the 2013 ACR/EULAR classification criteria
Intervention: Patient questionnaires (Other)
Group 3-Systemic sclerosis (SSc)
Adults aged 18 years or older with a diagnosis of systemic sclerosis meeting the 2013 ACR/EULAR classification criteria
Intervention: Examination (Other)
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
Intervention: Blood test and principal collection (Biological)
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
Intervention: Optional collection (Biological)
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
Intervention: Patient questionnaires (Other)
Outcomes
Primary Outcomes
AUC-ROC discriminant performance of multi-omic biomarkers
Time Frame: Baseline to 60 months
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.
Secondary Outcomes
- Characterization of Pathophysiological Mechanisms Through Multi-Omic and Spatial Immune Profiling(Baseline, disease flare (if applicable), and end of follow-up (Month 60))