Prospective Cohort Study of Clinical and Biological Data in Patients With Autoimmune Diseases (Immun4Cure Cohort)
Study to collect health data and biological samples from patients with autoimmune diseases.
Plain English Summary
Prospective Clinical and Biological Study of Autoimmune Diseases (Immun4Cure Cohort) is a Not Applicable clinical trial sponsored by University Hospital, Montpellier studying Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis, Healthy Adult Volunteers. This study is collecting detailed health information and biological samples (blood, urine, stool, saliva) from people with rheumatoid arthritis, lupus, and scleroderma, as well as healthy volunteers. It aims to build a large database and biobank to better understand these autoimmune diseases. Participation involves providing samples and completing questionnaires about your health and lifestyle. There are no new treatments being tested; this is an observational study to gather information. The trial aims to enroll 500 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older can join. You can join if you have a confirmed diagnosis of rheumatoid arthritis, systemic lupus erythematosus, or systemic sclerosis. Healthy adults without symptoms of autoimmune disease and no close family history of these conditions can also join as controls. You cannot join if you are pregnant, unable to give consent, or currently in another interventional study with an exclusion period. This trial is studying Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis, Healthy Adult Volunteers, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how well different biological markers can help distinguish between different types of autoimmune diseases, which could lead to more precise diagnoses. The specific primary outcome measures are: AUC-ROC discriminant performance of multi-omic biomarkers (Baseline to 60 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it aims to create a comprehensive resource of data and biological samples to deepen our understanding of autoimmune diseases, potentially leading to better diagnostic tools This research targets Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis, Healthy Adult Volunteers, where improved treatment options are needed.
Investor Insight
This observational study is building a valuable dataset for autoimmune diseases, a significant market with ongoing research and development for new therapies, suggesting potential for future therapeut
Is This Trial Right for Me?
Ask your doctor if your current treatment plan is compatible with participating in this study. Be prepared to provide blood, urine, and potentially stool or saliva samples. You will need to complete questionnaires about your medical history, lifestyle, and environmental exposures. The trial is being conducted at multiple sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 500 participants
Interventions
- BIOLOGICAL: 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
- BIOLOGICAL: Optional collection — The optional collection will include: * stool sample (50 mL) * urine sample (50 mL) * saliva sample (2 mL)
- OTHER: 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
- OTHER: 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
Primary Outcomes
- AUC-ROC discriminant performance of multi-omic biomarkers (Baseline to 60 months)
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))
Full Eligibility Criteria
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
Frequently Asked Questions
What is clinical trial NCT07515638?
NCT07515638 is a Not Applicable OBSERVATIONAL study titled "Prospective Clinical and Biological Study of Autoimmune Diseases (Immun4Cure Cohort)." It is currently not yet recruiting and is sponsored by University Hospital, Montpellier. The trial targets enrollment of 500 participants.
What conditions does NCT07515638 study?
This trial investigates treatments for Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis, Healthy Adult Volunteers. The primary condition under study is Rheumatoid Arthritis.
What treatments are being tested in NCT07515638?
The interventions being studied include: Blood test and principal collection (BIOLOGICAL), Optional collection (BIOLOGICAL), Patient questionnaires (OTHER), Examination (OTHER). 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
What does Not Applicable mean for NCT07515638?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07515638?
This trial is currently "Not Yet Recruiting." It started on 2026-05-01. The estimated completion date is 2034-05-01.
Who is sponsoring NCT07515638?
NCT07515638 is sponsored by University Hospital, Montpellier. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07515638?
The trial aims to enroll 500 participants. The trial has not yet started recruiting.
How is NCT07515638 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07515638?
The primary outcome measures are: AUC-ROC discriminant performance of multi-omic biomarkers (Baseline to 60 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where can I find official information about NCT07515638?
The official record for NCT07515638 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07515638. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07515638 testing in simple terms?
This study is collecting detailed health information and biological samples (blood, urine, stool, saliva) from people with rheumatoid arthritis, lupus, and scleroderma, as well as healthy volunteers. It aims to build a large database and biobank to better understand these autoimmune diseases.
Why is this trial significant?
This trial matters because it aims to create a comprehensive resource of data and biological samples to deepen our understanding of autoimmune diseases, potentially leading to better diagnostic tools
What are the potential risks of participating in NCT07515638?
The main risks involve discomfort or bruising from blood draws. There is a small risk of infection at the site of any biopsies, though these are optional. Some optional tests like biopsies may carry specific risks depending on the procedure. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07515638?
Ask your doctor if your current treatment plan is compatible with participating in this study. Be prepared to provide blood, urine, and potentially stool or saliva samples. You will need to complete questionnaires about your medical history, lifestyle, and environmental exposures. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07515638 signal from an investment perspective?
This observational study is building a valuable dataset for autoimmune diseases, a significant market with ongoing research and development for new therapies, suggesting potential for future therapeut This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves providing samples and completing questionnaires about your health and lifestyle. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.