Prospective Cohort Study of Clinical and Biological Data in Patients With Autoimmune Diseases (Immun4Cure Cohort)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- AUC-ROC discriminant performance of multi-omic biomarkers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •(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
研究组 & 干预措施
Group 1-Rheumatoid arthritis (RA)
Adults aged 18 years or older with a diagnosis of rheumatoid arthritis meeting the 2010 ACR/EULAR classification criteria
干预措施: 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
干预措施: 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
干预措施: Patient questionnaires (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
干预措施: 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
干预措施: 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
干预措施: 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
干预措施: 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
干预措施: 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
干预措施: 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
干预措施: 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
干预措施: 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
干预措施: 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
干预措施: 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
干预措施: 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
干预措施: 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
干预措施: Examination (Other)
结局指标
主要结局
AUC-ROC discriminant performance of multi-omic biomarkers
时间窗: 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.
次要结局
- Characterization of Pathophysiological Mechanisms Through Multi-Omic and Spatial Immune Profiling(Baseline, disease flare (if applicable), and end of follow-up (Month 60))