Immun4Cure Cohort of Autoimmune Diseases

Официальное название

Prospective Cohort Study of Clinical and Biological Data in Patients With Autoimmune Diseases (Immun4Cure Cohort)

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат Blood test and principal collection
  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, C
• Биопрепарат Optional collection
  The optional collection will include: * stool sample (50 mL) * urine sample (50 mL) * saliva sample (2 mL)
• Другое Patient questionnaires
  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
• Другое Examination
  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

Первичные конечные точки

• AUC-ROC discriminant performance of multi-omic biomarkers [Срок оценки: Baseline to 60 months]

Вторичные конечные точки (1)

• Characterization of Pathophysiological Mechanisms Through Multi-Omic and Spatial Immune Profiling [Срок оценки: Baseline, disease flare (if applicable), and end of follow-up (Month 60)]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• CHU de Montpellier - CIMA — Montpellier

Идентификаторы

NCT: NCT07515638 · RECHMPL24_0439 · IdRCB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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