Immun4Cure Cohort of Autoimmune Diseases

Sponsor
University Hospital, Montpellier
Study ID
NCT07515638
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Blood test and principal collection — BIOLOGICAL
    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 collection — BIOLOGICAL
    The optional collection will include: * stool sample (50 mL) * urine sample (50 mL) * saliva sample (2 mL)
  • 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
  • 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

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
May 1, 2031
Completion
May 1, 2034

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Group 1-Rheumatoid arthritis (RA)
    Adults aged 18 years or older with a diagnosis of rheumatoid arthritis meeting the 2010 ACR/EULAR classification criteria
  • Arm: 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
  • Arm: Group 3-Systemic sclerosis (SSc)
    Adults aged 18 years or older with a diagnosis of systemic sclerosis meeting the 2013 ACR/EULAR classification criteria
  • Arm: 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

Primary Outcome Measure

AUC-ROC discriminant performance of multi-omic biomarkers [ Time Frame: Baseline to 60 months ]

Central Contacts

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