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NCT Number: NCT06576505

Immunological Mechanisms in Sarcoidosis

There is no cure for the inflammatory disease sarcoidosis. Virtually any part of the body can be affected but most often the lungs and lymph nodes. Outcomes after diagnosis vary widely among sarcoidosis patients, with some experiencing resolving disease and others developing chronic disease and lung fibrosis. Cardiac sarcoidosis can lead to life threatening arrythmias and calcium metabolism disturbances can lead to renal impairment.

Treatment with different forms of immunosuppressants are usually tried to dampen symptoms but are not effective in all patients. Furthermore, the disease usually flares up after cessation of treatment. The variability in diseae course and treatment response is thought, at least to some degree, to be explained by individual differences in genetics, immune cells and signaling pathways. But existing evidence is limited. In other inflammatory diseases the gut microbiome is of importance for disease course but its role in sarcoidosis has not been clarified.

In this prospective project the investigators will study genes, inflammatory cells and signaling molecules in the lung, upper airways and blood, and to some extent microbes, also in faeces. Healthy volunteers will be included for comparative studies. Most samples will be taken during normal diagnostic work-up and follow-up of patients with/with suspected sarcoidosis. The findings will be correlated to disease course and effects of different treatments. By linking to national health data and demographic registries, comorbidities and environmental factors will be correlated to data.

By this, the investigators hope to improve understanding of which genes, cells and signaling molecules that are of importance for resolving vs non-resolving disease and why some patients respond to a certain treatment and others don´t. The overall goal is to assess and predict sarcoidosis outcomes. We hypothesize that blood-based biomarkers including those taken during routine care as well as novel cell, signaling molecules and genetic markers, in combination with clinical characteristics can be used to predict outcomes, also treatment response, in sarcoidosis. The results can lead to tailored treatment and individual follow-up for each patient with sarcoidosis.

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Key information

Conditions

Sarcoidosis Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lymphatic Diseases Lymphoproliferative Disorders

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital

Stockholm, Stockholm County, 171 76, Sweden

Location status: Recruiting

Location contact

Susanna Kullberg, MD

CONTACT

[email protected]

070-2715639 ext. +46

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Suspicion of sarcoidosis
  • Swedish speaking
  • Able to understand and approve of study protocol
  • No contraindications for planned interventions
  • For inclusion of healthy controls they need to be healthy and the same criteria as listed above for patients.

Exclusion criteria

  • No suspicion of sarcoidosis
  • Not Swedish-speaking
  • Not able to understand study protocol
  • Not approving of study protocol
  • Contraindications for planned interventions

Treatment and study plan

peripheral blood sampling, bronchoscopy, upper airway and faeces sampling

Procedure
  • Repeated peripheral blood sampling at diagnostic and follow-up visits, in total a maximum of 400 ml/year but never more than 100 ml/ month.
  • Upper airway sampling wih swab, aspirate and curettage, maximum 3 times/year.
  • Faeces sampling, the patients do this themselves and leave it to the research unit, maximum 3 times/year.
  • Bronchoscopy with lavage and a maximum of 6 mucosal biopsies before and after 6-12 months treatment.

Primary outcomes

  1. Disease activity

    Time frame: 3 months and 12 months

    This refers to cardiac sarcoidosis and is estimated with PET-CT

  2. Number of participants with resolving vs non-resolving disease

    Time frame: 2 and 5 years from baseline

    Data will be collected from the medical record wether the disease resolved or not

  3. Number of participants with immunosuppressive treatment

    Time frame: 5 years

    Data on treatment will be collected from the medical record

  4. Number of participants with more than 10% change from enrollment in percent of predicted Forced Expiratory Volume in one second (L/s) at 5 years

    Time frame: Baseline and 5 years

    Measured with spirometry

  5. Change from enrollment in Immunoglobulin G (g/L) at 5 years

    Time frame: Baseline and 5 years

    Measured in serum

  6. Change from enrollment in fatigue at 5 years

    Time frame: Baseline and 5 years

    The Fatigue Assessment Scale will be used. Maximum score is 50 and minimum 10. A higher score means more fatigue.More than 22 points means the participant suffers from fatigue and more than 34 extreme fatigue.

  7. Change from enrollment of radiographic findings at 5 years

    Time frame: Baseline and 5 years

    Chest X-ray will be classified according to Scadding staging

  8. Change from enrollment of angiotensin converting enzyme (E/L) at 5 years

    Time frame: Baseline and 5 years

    Measured in serum

  9. Change from enrollment of soluble Interleukin Receptor 2 (U/ml) at 5 years

    Time frame: Baseline and 5 years

    Measured in serum

  10. Change from enrollment of complete blood cell count (/10x9 L) at 5 years

    Time frame: Baseline and 5 years

    Measured in blood

  11. Change from enrollment of creatinine levels (micromol/L) at 5 years

    Time frame: Baseline and 5 years

    Measured in plasma

  12. Change from enrollment of C-reactive protein (mg/L) at 5 years

    Time frame: Baseline and 5 years

    Measured in serum

  13. Number of patients with more than 10% change from enrollment in percent of predicted Diffusing capacity of the Lungs for Carbon Monoxide (%) at 5 years

    Time frame: Baseline and 5 years

    Measured with spirometry

  14. Number of participants with more than 10% change from enrollment in percent of predicted Forced Vital Capacity (L) at 5 years

    Time frame: Baseline and 5 years

    Measured with spirometry

  15. Change from enrollment of calcium levels (mmol/L) at 5 years

    Time frame: Baseline and 5 years

    Measured in serum

Study contacts

Contact information is provided by the study sponsor or research team.

Susanna M Kullberg, MD

CONTACT

[email protected]

070-2715639 ext. +46

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Collaborators

  • Karolinska Institutet

Registry information

Official study title

Immunologiska Mekanismer Vid Sarkoidos

Important dates

Study start
2024
Primary completion
2029
Study completion
2034
First posted
Aug 28, 2024
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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