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Recruiting NCT04334031

Deployment o the Multidisciplinary Prospective Cohort Imminent

No phase Interventional Chronic Inflammatory Disease Angioedema Severe Asthma Lupus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biobanking with genetic analysis, SF-12 questionnaire.
Who it may be relevant to
Registry conditions: Chronic Inflammatory Disease, Angioedema, Severe Asthma, Lupus. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Genetic Biobanking with genetic analysis
    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.
  • Other SF-12 questionnaire
    Patients included in the IMMINeNT cohort will be asked to complete SF-12 quality of life questionnaire.

Primary outcome measures

  • Change of SLEDAI for lupus [Time frame: once a year for 10 years]
  • Change of Medsger score [Time frame: once a year for 10 years]
  • Change of EDSS for multiple sclerosis [Time frame: once a year for 10 years]
  • Change of BASDAI for psoriatic arthristis [Time frame: once a year for 10 years]
  • Change of Longhurst criteria for hereditary angioedema [Time frame: once a year for 10 years]
  • Change of number of flares for atopic dermatitis [Time frame: once a year for 10 years]
  • Change of number of exacerbations for severe asthma [Time frame: once a year for 10 years]
  • Change of 12-Item Short-Form Health Survey (SF-12) - quality of life scale [Time frame: once a year for 10 years]
  • number of participant with severe infectious events [Time frame: once a year for 10 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Hop Claude Huriez Chu Lille — Lille

Identifiers

NCT: NCT04334031 · 2018_82 · 2019-A01309-48

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗