Actively Recruiting

All Genders
Healthy Volunteers
ID06248957

Systems-Level Analyses of Immune Dysregulation in Patients and Healthy Controls with Sample Collection and Clinical Data

Led by Karolinska Institutet · Updated on 2024-02-08

500

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

K

Karolinska Institutet

Lead Sponsor

K

Karolinska University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating immune dysregulation, a broad group of complex conditions where the immune system either overreacts, underreacts, or responds inappropriately. These conditions include immunodeficiencies, autoimmune disorders, autoinflammatory syndromes, severe allergies, and lymphoproliferation. The study aims to create a national resource in Sweden by collecting detailed immunological data and biological samples to better understand these diseases and their relationship with the microbiome. The study involves collecting primarily blood and fecal samples from both patients with confirmed or suspected immune dysregulation and healthy age- and sex-matched controls. Participants include those receiving various immunomodulatory therapies, and samples are taken before and during treatment. The project also establishes a national database housing deep immunological data alongside clinical outcomes, accessible to researchers and clinicians. Participants will provide samples over the course of their care, allowing researchers to analyze immune cell composition, functional responses, and microbiome differences. The primary outcome measure is the control of immune dysregulation within 1 to 3 months from the start of therapy. Exploratory immunological parameters will also be assessed during this period. This observational study enables comprehensive immune system analyses without altering participants' standard treatments.

CONDITIONS

Brief Title

SYSTEMS-LEVEL ANALYSES OF IMMUNE DYSREGULATION

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Healthy control individuals with a diagnosis of an immune mediated disorder
  • Healthy control individuals currently receiving immunomodulatory treatment
  • Healthy control individuals with current infection
  • Healthy control individuals with cancer

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 1 to 3 months from start of therapy

Participants are observed through sample collection and clinical data gathering to analyze immune cell composition and functional responses over time.

Multiple visits depending on treatment schedule and assessments

Trial Site Locations

Total: 1 location

1

Karolinska Institutet

Stockholm, Sweden, SE171 77

Actively Recruiting

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Research Team

P

Petter Brodin, M.D., Ph.D

G

Genia Kretzschmar, M.D

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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