SYSTEMS-LEVEL ANALYSES OF IMMUNE DYSREGULATION

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorKarolinska Institutet

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

All subjects, children and adults in Sweden and referred to Swedish centers with known or suspected immune dysregulation.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Immunomodulation

    Combination product

    Variable protocols for combined immunomodulatory therapies currently in use for different forms of immune dysregulation

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Patients with immune dysregulation1 intervention
Group B: Healthy subjects0 interventions

Trial outcomes

Primary outcomes

1

control of immune dysregulation

Remission and control of immune dysregulation manifested as reduced inflammation, symptom relieve and halted immunoproliferation for examples

Time frame
1-3 months from start of therapy

Secondary outcomes

1

Exploratory immunological parameters

Systems-level immunomonitoring for exploration of cell state changes in response to therapy

Time frame
1-3 months from start of therapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Karolinska University Hospital

Collaborator

Skane University Hospital

Collaborator

Sahlgrenska University Hospital

Collaborator

Uppsala University Hospital

Collaborator

Region Halland

Collaborator

Region Jönköping County

Collaborator