RecruitingNCT07515638

Immun4Cure Cohort of Autoimmune Diseases

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


Sponsor

University Hospital, Montpellier

Enrollment

500 participants

Start Date

Jun 23, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Blood test and principal collection, Examination, and others for people with healthy adult volunteers, rheumatoid arthritis, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBlood 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, 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

BIOLOGICALOptional collection

The optional collection will include: * stool sample (50 mL) * urine sample (50 mL) * saliva sample (2 mL)

OTHERPatient 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 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

OTHERExamination

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


Locations(1)

CHU de Montpellier - CIMA

Montpellier, France

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NCT07515638


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