Deployment o the Multidisciplinary Prospective Cohort Imminent

NCT04334031 · University Hospital, Lille

Recruiting

In plain English

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About this study

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.

Eligibility criteria

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 design

Enrollment target: 2200 participants

Allocation: na

Masking: none

Age groups: adult, older_adult

Timeline

Starts: 2020-07-20

Estimated completion: 2031-07

Last updated: 2022-05-23

Interventions

Genetic: Biobanking with genetic analysisOther: SF-12 questionnaire

Primary outcomes

• Change of SLEDAI for lupus (once a year for 10 years)
• Change of Medsger score (once a year for 10 years)
• Change of EDSS for multiple sclerosis (once a year for 10 years)

Sponsor

University Hospital, Lille · other

With: 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)

Contacts & investigators

ContactDavid Launay, MD,PhD · contact · david.launay@chru-lille.fr · 03 20 44 42 95

InvestigatorDavid Launay, MD,PhD · principal_investigator, University Hospital, Lille

All locations (1)

Hop Claude Huriez Chu LilleRecruiting

Lille, France

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