The Diagnostic and Prognostic Role of SAA in Intrathoracic Sarcoidosis

NCT ID: NCT05811962

Last Updated: 2023-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2022-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sarcoidosis, Pulmonary

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intrathoracic sarcoidosis cohort

Patients with intrathoracic sarcoidosis, confirmed according to European Respiratory Society/ World Association of Sarcoidosis and Other Granulomatous disease (ERS/WASOG) criteria

No intervention

Intervention Type OTHER

No intervention, only comparison

Healthy controls

Healthy blood donors

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

No intervention, only comparison

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zala Leštan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zala Leštan Ramovš, MD

Role: PRINCIPAL_INVESTIGATOR

UMC Ljubljana

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of pulmonary diseases and allergy, UMC Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Slovenia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 18032765 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19910611 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33036432 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32760396 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UMCLjubljanaPulmo

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cell Free DNA in Cardiac Sarcoidosis
NCT03858777 RECRUITING NA
Mycophenolate for Pulmonary Sarcoidosis
NCT00262132 TERMINATED PHASE3
Lyon Sarcoid Uveitis Cohort
NCT03863782 RECRUITING