Deployment o the Multidisciplinary Prospective Cohort Imminent

Обзор

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.

Вмешательства

• Генная терапия 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.
• Другое SF-12 questionnaire
  Patients included in the IMMINeNT cohort will be asked to complete SF-12 quality of life questionnaire.

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Hop Claude Huriez Chu Lille — Lille

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗