Immunological Mechanisms in Sarcoidosis

NCT ID: NCT06576505

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-07
• Study Completion Date: 2034-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

peripheral blood sampling, bronchoscopy, upper airway and faeces sampling

Intervention Type: 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.

Interventions

peripheral blood sampling, bronchoscopy, upper airway and faeces sampling

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Region Stockholm

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susanna M Kullberg, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

Karolinska University Hospital

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Susanna M Kullberg, MD

Role: CONTACT

susanna.kullberg@regionstockholm.se

070-2715639 ext. +46

Facility Contacts

Susanna Kullberg, MD

Role: primary

susanna.kullberg@regionstockholm.se

070-2715639 ext. +46

Other Identifiers

K2024-5925

Identifier Type: -

Identifier Source: org_study_id