Clinical trial

SYSTEMS-LEVEL ANALYSES OF IMMUNE DYSREGULATION

Name
2023-06579-01
Description
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.
Trial arms
Trial start
2024-01-01
Estimated PCD
2030-12-31
Trial end
2031-12-31
Status
Recruiting
Treatment
Immunomodulation
Variable protocols for combined immunomodulatory therapies currently in use for different forms of immune dysregulation
Arms:
Patients with immune dysregulation
Size
500
Primary endpoint
control of immune dysregulation
1-3 months from start of therapy
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples with viable cells, DNA, plasma proteins. Microbiome samples from stool, airways and skin. Fibroblasts in selected cases.'}, 'enrollmentInfo': {'count': 500, 'type': 'ESTIMATED'}}
Updated at
2024-02-08

1 organization

1 product

5 indications

Indication
Allergy