Идёт набор NCT06576505

Immunological Mechanisms in Sarcoidosis

— Наблюдательное Sarcoidosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: peripheral blood sampling, bronchoscopy, upper airway and faeces sampling.
Кому может быть актуально: Состояния в реестре: Sarcoidosis. Базовые параметры: 18 лет — 90 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Швеция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Immunologiska Mekanismer Vid Sarkoidos

Обзор

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.

Вмешательства

Процедура 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.

Первичные конечные точки

Disease activity [Срок оценки: 3 months and 12 months]
Number of participants with resolving vs non-resolving disease [Срок оценки: 2 and 5 years from baseline]
Number of participants with immunosuppressive treatment [Срок оценки: 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 [Срок оценки: Baseline and 5 years]
Change from enrollment in Immunoglobulin G (g/L) at 5 years [Срок оценки: Baseline and 5 years]
Change from enrollment in fatigue at 5 years [Срок оценки: Baseline and 5 years]
Change from enrollment of radiographic findings at 5 years [Срок оценки: Baseline and 5 years]
Change from enrollment of angiotensin converting enzyme (E/L) at 5 years [Срок оценки: Baseline and 5 years]
Change from enrollment of soluble Interleukin Receptor 2 (U/ml) at 5 years [Срок оценки: Baseline and 5 years]
Change from enrollment of complete blood cell count (/10x9 L) at 5 years [Срок оценки: Baseline and 5 years]

Критерии участия

Критерии включения

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.