SYSTEMS-LEVEL ANALYSES OF IMMUNE DYSREGULATION

NCT06248957 | Recruiting

• 1 other identifier: 2023-06579-01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Immunodeficiency; Autoimmune Diseases; Autoinflammatory Syndrome; Allergy; Dysregulated Host Response

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Exploratory immunological parameters

  1-3 months from start of therapy

Study Arms (2)

Patients with immune dysregulation

Patients sampled before and during different immunomodulatory therapies due to immune system dysregulation.

Combination Product: Immunomodulation

Healthy subjects

Age-matched healthy individuals sampled longitudinally

Interventions

Immunomodulation COMBINATION_PRODUCT

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

Patients with immune dysregulation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator
• Skane University Hospital: collaborator
• Sahlgrenska University Hospital: collaborator
• Uppsala University Hospital: collaborator
• Region Halland: collaborator
• Region Jönköping County: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, SE171 77, Sweden

RECRUITING

Related Links

• Brodin lab website

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples with viable cells, DNA, plasma proteins. Microbiome samples from stool, airways and skin. Fibroblasts in selected cases.

MeSH Terms

Conditions

Immunologic Deficiency Syndromes; Autoimmune Diseases; Hypersensitivity

Interventions

Immunomodulation

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Immune System Phenomena

Central Study Contacts

Petter Brodin, M.D., Ph.D

CONTACT

08 524 813 96; petter.brodin@ki.se

Genia Kretzschmar, M.D

CONTACT

genia.kretzschmar@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D., Professor

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: February 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)