ImmunAID

• Research type

  Research Study

• Full title

  IMMUNOME PROJECT CONSORTIUM FOR AUTOINFLAMMATORY DISORDERS

• IRAS ID

  276218

• Contact name

  Sandrine Couffin-Cadiergues

• Contact email

  sandrine.couffin-cadiergues@inserm.fr

• Sponsor organisation

  INSERM- Clinical Research Department

• Clinicaltrials.gov Identifier

  NCT03919110

• Duration of Study in the UK

  4 years, 0 months, 0 days

• Research summary

  Systemic autoinflammatory diseases (SAID) are a set of conditions which include several rare disorders characterized by extensive clinical and biological inflammation. They occur across age groups and gender. It is difficult to diagnose SAID due to the numerous symptoms observed in the different SAID-related conditions (fever, rash, joint pain or swelling, etc.) and because these symptoms are not specific to one condition. There are currently no disease-defining biomarker(s). Diagnosis is thus primarily clinical and relies on detailed patient history to study the pattern of symptoms at each flare up. Difficulty in diagnosis can lead to delays in treating patients appropriately, delays in correct referral and treatment. This greatly affects patient quality of life and increases disease costs for the health service providers.
  The ImmunAID study aims to enable a rapid and accurate diagnosis across the spectrum of SAID in order to improve clinical management of SAID patients, through a step by step approach as follows:
  -Identification and validation of novel Omics- and pathway-based diagnostic biomarkers (particularly inflammation pathways)
  -Development of a robust clinical decision algorithm to assist physicians, (triage process) when facing a patient with suspected SAID, thus avoiding the prescription of costly and often inadequate diagnostic investigations
  - reorganization of SAID into a new comprehensive and pathogenesis-driven classification
  ImmunAID is a multicenter (37 sites) and multinational (11 European countries) prospective cohort study. Population will include four groups of individuals as follows.
  1.Genetically Undiagnosed SAID Patients (guSAID) (adults+children)
  2.Parents of guSAID patients (mother and father)
  3. Monogenic SAID patients (mSAID) as positive controls (adults+children)
  4. Controls subjects as negative controls (free of inflammatory disorders) (adults+children)
  Samples collected from the populations will be used to identify novel biomarkers which researchers will use to develop diagnostic classification algorithm for SAID.
  1616 participants will be enrolled. All will attend baseline and some will also attend M3 visits and complete follow-up visit at M12

• REC name

  South West - Frenchay Research Ethics Committee

• REC reference

  20/SW/0022

• Date of REC Opinion

  18 Aug 2020

• REC opinion

  Further Information Favourable Opinion