Immunological Mechanisms in Sarcoidosis

NCT06576505 | Recruiting

• 1 other identifier: K2024-5925
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcoidosis

Outcome Measures

Primary Outcomes (15)

• Disease activity

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

  3 months and 12 months

• Number of participants with resolving vs non-resolving disease

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

  2 and 5 years from baseline

• Number of participants with immunosuppressive treatment

  Data on treatment will be collected from the medical record

  5 years

• 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

  Measured with spirometry

  Baseline and 5 years

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

  Measured in serum

  Baseline and 5 years

• Change from enrollment in fatigue at 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.

  Baseline and 5 years

• Change from enrollment of radiographic findings at 5 years

  Chest X-ray will be classified according to Scadding staging

  Baseline and 5 years

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

  Measured in serum

  Baseline and 5 years

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

  Measured in serum

  Baseline and 5 years

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

  Measured in blood

  Baseline and 5 years

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

  Measured in plasma

  Baseline and 5 years

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

  Measured in serum

  Baseline and 5 years

• 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

  Measured with spirometry

  Baseline and 5 years

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

  Measured with spirometry

  Baseline and 5 years

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

  Measured in serum

  Baseline and 5 years

Study Arms (1)

Sarcoidosis patients

This study only consists of one arm. The investigators follow patients prospectively and observe clinical parameters including disease course (resolving, non-resolving, which organs are involved, inflammatory markers, chest X-ray etc) and effect of treatment. In this respect the study is observational. However, the patients undergo repeated peripheral blood samples and some also undergo sampling from upper airways, faeces and a bronchoscopy and hence, the study falls in the interventional category

Procedure: peripheral blood sampling, bronchoscopy, upper airway and faeces sampling

Interventions

peripheral blood sampling, bronchoscopy, upper airway and faeces sampling PROCEDURE

1. 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. 2. Upper airway sampling wih swab, aspirate and curettage, maximum 3 times/year. 3. Faeces sampling, the patients do this themselves and leave it to the research unit, maximum 3 times/year. 4. Bronchoscopy with lavage and a maximum of 6 mucosal biopsies before and after 6-12 months treatment.

Sarcoidosis patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with/with a suspicion of sarcoidosis referred to Department of Respiratory Medicine, Karolinska University Hospital, Stockholm, Sweden. A total of 4600 patients are planned to be included during 10 years (460/year). Healthy volunteers will be recruited through advertisments (web based platforms within Karolinska Institutet, magazines, notice-boards). A total of 400 are planned to be included during 10 years (40/year).

You may qualify if:

• Suspicion of sarcoidosis
• Swedish speaking
• Able to understand and approve of study protocol
• No contraindications for planned interventions

You may not qualify if:

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

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, Stockholm County, 171 76, Sweden

RECRUITING

MeSH Terms

Conditions

Sarcoidosis

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Susanna M Kullberg, MD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanna M Kullberg, MD

CONTACT

070-2715639; susanna.kullberg@regionstockholm.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 28, 2024
• Study Start: July 7, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2034
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

SE (1)