Clinical trial NCT05811962: The Diagnostic and Prognostic Role of SAA in Intrathoracic Sarcoidosis
Official title: The Role of Serum Amyloid A in Clinical Decision-making Concerning Sarcoidosis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoidosis, Pulmonary
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * All patients comply with the accepted European Respiratory Society/ World Association of Sarcoidosis and Other Granulomatous disease (ERS/WASOG) guidelines for the diagnosis of sarcoidosis and have undergone complete functional and radiological assessment, including spirometry.
* Histological confirmation of non-caseating granulomas in thoracic lymph nodes and lung parenchyma has been obtained by flexible bronchoscopy, as well as bronchoalveolar lavage (BAL) fluid for the determination of BAL CD4+/CD8+ ratio.

Brief summary: The goal of this observational study is to elucidate the role of serum amyloid A (SAA) in the diagnosis and follow-up of sarcoidosis, including its prognostic value. The main questions it aims to answer are:

* Whether, at the time of diagnosis, SAA is in correlation with other serum markers of granulomatous inflammation, interstitial disease and pulmonary fibrosis, lung function and radiologic characteristics of intrathoracic sarcoidosis,
* Whether increased serum concentrations of SAA at the time of diagnosis act as a prognostic marker of progressive granulomatous inflammation and pulmonary interstitial disease.

Patients will undergo standard diagnostic procedures for intrathoracic sarcoidosis, according to WASOG (World association of sarcoidosis and other granulomatous disorders) criteria. Two additional vials of blood will be taken at diagnosis and one vial at follow-up for serum processing and biomarker analysis.

Healthy blood donors will represent our group of healthy controls.


Eligibility criteria: Inclusion Criteria:

* Above 18 years of age
* Enrolled immediately after the first diagnostic workup and before any treatment was initiated.

Exclusion Criteria:

* Individuals with granulomatous disease that could not be unequivocally diagnosed as sarcoidosis were excluded, as well as patients with possible confounding other known systemic inflammatory illnesses, acute infection, patients on immunosuppressive drugs or immunotherapy and patients with active cancer.

Primary outcomes:
measure: The correlation of mean serum concentration of serum amyloid A (SAA) in patients, newly diagnosed with intrathoracic sarcoidosis to mean value in healthy controls
timeFrame: 4 years for patient enrollment
measure: The correlation of serum concentrations of serum amyloid A (SAA) at the time of diagnosis of intrathoracic sarcoidosis with serum concentrations of other biomarkers of granulomatous inflammation and pulmonary interstitial disease.
timeFrame: 4 years for patient enrollment
measure: Correlation of serum concentrations of SAA at the time of diagnosis of intrathoracic sarcoidosis to pulmonary function test results.
timeFrame: 4 years for patient enrollment
measure: Correlation of serum concentrations of SAA at the time of diagnosis of intrathoracic sarcoidosis to radiologic extent of disease.
timeFrame: 4 years for patient enrollment
measure: Correlation of serum concentrations of SAA at the time of diagnosis of intrathoracic sarcoidosis to changes in lung function tests after 3 years of follow-up.
timeFrame: 3 years follow-up
measure: Correlations of serum concentrations of SAA at the time of diagnosis of intrathoracic sarcoidosis to changes in HRCT disease extent after 3 years of follow-up.
timeFrame: 3 years follow-up
measure: Correlation of serum concentrations of SAA at the time of diagnosis of intrathoracic sarcoidosis to need for recent/ongoing therapy after 3 years of follow-up.
timeFrame: 3 years follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Department of pulmonary diseases and allergy, UMC Ljubljana
Study officials:
affiliation: UMC Ljubljana
name: Zala Leštan Ramovš, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iannuzzi MC, Rybicki BA, Teirstein AS. Sarcoidosis. N Engl J Med. 2007 Nov 22;357(21):2153-65. doi: 10.1056/NEJMra071714. No abstract available.
citation: Chen ES, Song Z, Willett MH, Heine S, Yung RC, Liu MC, Groshong SD, Zhang Y, Tuder RM, Moller DR. Serum amyloid A regulates granulomatous inflammation in sarcoidosis through Toll-like receptor-2. Am J Respir Crit Care Med. 2010 Feb 15;181(4):360-73. doi: 10.1164/rccm.200905-0696OC. Epub 2009 Nov 12.
citation: Zhou ER, Arce S. Key Players and Biomarkers of the Adaptive Immune System in the Pathogenesis of Sarcoidosis. Int J Mol Sci. 2020 Oct 7;21(19):7398. doi: 10.3390/ijms21197398.
citation: Kraaijvanger R, Janssen Bonas M, Vorselaars ADM, Veltkamp M. Biomarkers in the Diagnosis and Prognosis of Sarcoidosis: Current Use and Future Prospects. Front Immunol. 2020 Jul 14;11:1443. doi: 10.3389/fimmu.2020.01443. eCollection 2020.