Allergy Clinical Trial
— SAIDOfficial title:
SYSTEMS-LEVEL ANALYSES OF IMMUNE DYSREGULATION
The aim of the SAID study is to create a national resource in Sweden to enable comprehensive immunological analyses of an extremely complex and clinically challenging group of individuals with variable forms of immune system dysregulation. We hope to establish a biobank of primarily blood and fecal samples from children and adults, with confirmed or suspected immune dysregulation, as well as age- and sex- matched healthy controls, for comparisons of immune cell/mediator alongside various clinical presentations of these immunological diseases as well as microbiome samples as possible a possible modifier of clinical presentations. The project will also include the establishment of a national database with deep immunological data, treatment and clinical outcomes for these patients, accessible to participating researchers and clinicians.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 31, 2031 |
Est. primary completion date | December 31, 2030 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: Patients of all ages seeking care or being referred for suspected immune dysregulation or with a known immune-mediated disease and failing to respond to standard therapy Exclusion Criteria: Healthy control individuals will be excluded on the basis of having a diagnosis of an immune mediated disorder, immunomodulatory treatment or current infection or cancer. |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska Institutet | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Karolinska University Hospital, Region Halland, Region Jönköping County, Sahlgrenska University Hospital, Sweden, Skane University Hospital, Uppsala University Hospital |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | control of immune dysregulation | Remission and control of immune dysregulation manifested as reduced inflammation, symptom relieve and halted immunoproliferation for examples | 1-3 months from start of therapy | |
Secondary | Exploratory immunological parameters | Systems-level immunomonitoring for exploration of cell state changes in response to therapy | 1-3 months from start of therapy |
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