ClinicalTrials.gov record NCT04334031
Deployment o the Multidisciplinary Prospective Cohort Imminent
Deployment o the Multidisciplinary Prospective Cohort Imminent
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This interventional cohort study enrolls adults (18+) with immune-mediated inflammatory diseases to collect clinical data, yearly disease-specific measures, quality-of-life questionnaires, and blood samples. Participants provide samples for a biobank and may agree to genetic analysis. Data are collected annually and followed for up to 10 years to study disease activity, severity, quality of life, and treatment response.
What it is studying. The study seeks prognostic and therapeutic biomarkers and factors linked to disease activity, severity, quality of life, and response or tolerance to treatments across multiple immune-mediated inflammatory diseases.
What the researchers hope to learn. To identify new prognostic and therapeutic biomarkers, to develop new therapeutic targets, and to identify factors related to disease activity, severity, quality of life, and treatment response and tolerance in IMIDs.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
Immune-mediated inflammatory diseases (IMIDs) most often affect young patients and have high impact on morbidity and mortality with a significant alteration in the quality of life of patients with professional, social and emotional repercussions. Beyond this burden, IMIDs share many common pathophysiological mechanisms and treatments, known as "targeted therapies". Despite progress in this field, much remains to be done in clinical, therapeutic and fundamental research to address the efficacy, resistance and side-effects of treatment. These similarities between IMIDs have led the FHU IMMINeNT to propose the creation of a prospective, multidisciplinary clinical-biological database (IMMINeNT cohort), associated to a biobank, of patients with IMIDs. The main objectives of this database will be to identify new prognostic and therapeutic biomarkers in order to develop new therapeutic targets and biomarkers, to identify prognostic factors and determinants related to the activity, severity and quality of life of patients with IMIDs as well as to the response and tolerance to treatment.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Genetic
- Biobanking with genetic analysis
- Other
- SF-12 questionnaire
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Patient followed for their IMID in one of the departments of the Lille University Hospital participating in the study (dermatology, internal medicine, neurology, pneumology and rheumatology)
- Social insured
- Have the capacity to understand the study requirements, provide written informed consent, and comply with the study data collection procedures.
Exclusion criteria
- Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of coverage by the social security system.
- Pregnant or breastfeeding woman
- Persons deprived of liberty
- Protected minors or adults
- Persons who have refused or are incapable of giving informed consent
- Persons in Emergency Situations
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
At enrollment and at each re-evaluation visit participants will give blood samples (the record says seven blood samples per re-evaluation visit). If you agree, part of the blood will be used for genetic (DNA) analysis. You will complete the SF-12 quality-of-life questionnaire. The study records disease-activity measures and serious infections once a year for up to 10 years.
How the study is structured. Single-group interventional study: all participants join the IMMINeNT cohort and receive the same procedures. Participants give multiple blood samples at follow-up visits, complete the SF-12 quality-of-life questionnaire, and undergo yearly disease-specific assessments for up to 10 years. Genetic analysis may be performed on stored samples for those who consent. The study is not masked and has no comparison group.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Behçet's disease
This trial is also listed on this site under familial Mediterranean fever.
Important dates
- Study start
- Jul 20, 2020
- Primary completion
- Jul 20, 2031 (estimated)
- Study completion
- Jul 21, 2031 (estimated)
- Target enrollment
- 2200 participants (estimated)
- Last updated on registry
- May 5, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- University Hospital, Lille
- Collaborators
- FHU IMMINeNT
- FHU PRECISE: Projet Fédératif Hospitalo-Universitaire PREcision health in Complex Immune-mediated inflammatory diseaSEs
- Fond de dotation de la Société Française de Dermatologie (SFD)
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- David Launay, MD,PhD 📞 03 20 44 42 95 ext. +33 ✉ david.launay@chru-lille.fr
Participating sites (1)
- Hop Claude Huriez Chu LilleRecruiting
Lille, 59037 · France
Terms used on this page · explanations by MedicalUpdates.ai
- cohort
- A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
- biobank
- A collection of biological samples, such as blood or tissue, stored with medical information so that researchers can study them later.
- biomarkers
- Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
- written informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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