Deployment o the Multidisciplinary Prospective Cohort Imminent

Sponsor
University Hospital, Lille
Study ID
NCT04334031
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biobanking with genetic analysis — GENETIC
    Patients included in the IMMINeNT cohort will be collected 7 blood samples for the research project at each revaluation visit. For patients who accepted, genetic analysis (DNA analysis) will be done on a part of those samples.
  • SF-12 questionnaire — OTHER
    Patients included in the IMMINeNT cohort will be asked to complete SF-12 quality of life questionnaire.

Study Details

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.

Key Dates

First listed
Apr 3, 2020
Start date
Jul 20, 2020
Status verified
Apr 2026
Primary completion
Jul 20, 2031
Completion
Jul 21, 2031

Study Design

Enrollment
2,200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: IMMINeNT cohort

Primary Outcome Measure

Change of SLEDAI for lupus [ Time Frame: once a year for 10 years ]

Central Contacts

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