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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peripheral blood sampling, bronchoscopy, upper airway and faeces sampling | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susanna M Kullberg, MD | Contact | 070-2715639 | +46 | susanna.kullberg@regionstockholm.se |
| Name | Affiliation | Role |
|---|---|---|
| Susanna M Kullberg, MD | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Recruiting | Stockholm | Stockholm County | 171 76 | Sweden |
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| ID | Term |
|---|---|
| D012507 | Sarcoidosis |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
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| ID | Term |
|---|---|
| D001999 | Bronchoscopy |
| ID | Term |
|---|---|
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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|
| 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 |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |