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Sarcoidosis, PulmonarySARCONCT05811962

The Diagnostic and Prognostic Role of SAA in Intrathoracic Sarcoidosis

An observational study of Sarcoidosis, Pulmonary, run by University Medical Centre Ljubljana at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoidosis, Pulmonary
How many people
135 participants
Where
1 siteSlovenia
Study dates
1 Jan 2014to 1 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Slovenia1 site

  • Department of pulmonary diseases and allergy, UMC Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: The Role of Serum Amyloid A in Clinical Decision-making Concerning Sarcoidosis Patients

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.
Read more

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.

Being tested
No intervention
Medical subject headings
Sarcoidosis, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    No intervention, only comparison

Study groups in NCT05811962
Study groupRoleWhat they receive
Intrathoracic sarcoidosis cohortPatients with intrathoracic sarcoidosis, confirmed according to European Respiratory Society/ World Association of Sarcoidosis and Other Granulomatous disease (ERS/WASOG) criteria
Receives: Other: No intervention
Healthy controlsHealthy blood donors

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The correlation of mean serum concentration of serum amyloid A (SAA) in patients, newly diagnosed with intrathoracic sarcoidosis to mean value in healthy controls

    The mean serum concentration of serum amyloid A (SAA) (in micrograms per millilitre) in patients, newly diagnosed with intrathoracic sarcoidosis will be determined for our entire intrathoracic sarcoidosis cohort and separately first for patients in different Scadding stages (0-4) and secondly according to high-resolution computed tomography (HRCT) pattern (lymph node enlargement, peribronchovascular/perilymphatic lesions, ground-glass lesions and pulmonary fibrosis). The mean values will then be compared to the mean value of SAA in healthy controls to determine possible statistically significant differences.

    Measured: 4 years for patient enrollment

  2. 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.

    We will determine whether serum concentrations of SAA at the time of diagnosis of intrathoracic sarcoidosis corelate to serum concentrations of granulomatous disease markers (CC chemokine ligand 18 (CCL18), monokine induced by interferon-γ (CXCL9), interferon-γ-induced protein 10 (CXCL10)) and activity of serum chitotriosidase (CTO) and serum concentrations of biomarkers of interstitial lung disease and lung fibrosis (surfactant protein D (SP-D) and cancer antigen 15.3 (CA 15.3)/Krebs von den Lungen 6 (KL-6)).

    Measured: 4 years for patient enrollment

  3. Correlation of serum concentrations of SAA at the time of diagnosis of intrathoracic sarcoidosis to pulmonary function test results.

    We will determine whether serum concentrations of SAA corelate to results of lung function tests (percentages predicted of forced vital capacity, forced expiratory volume in 1 second and diffusion capacity for carbon monoxide) at the time of diagnosis of intrathoracic sarcoidosis.

    Measured: 4 years for patient enrollment

  4. Correlation of serum concentrations of SAA at the time of diagnosis of intrathoracic sarcoidosis to radiologic extent of disease.

    We will determine whether serum concentrations of SAA at the time of diagnosis of intrathoracic sarcoidosis correlate with extent of disease on HRCT, expressed in percentage of pulmonary parenchyma involved (0%, 0-33%, 33-66%, 66-100%).

    Measured: 4 years for patient enrollment

  5. 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.

    We will determine whether SAA concentrations at the time of diagnosis of intrathoracic sarcoidosis correlate with changes in lung function tests (percentages predicted of forced vital capacity, forced expiratory volume in 1 second and diffusion capacity for carbon monoxide) at patient follow-up after 3 years.

    Measured: 3 years follow-up

  6. 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.

    We will determine whether SAA concentrations at the time of diagnosis of intrathoracic sarcoidosis correlate with changes in HRCT disease extent (descriptive terms used: resolution, stagnation, progression) at patient follow-up after 3 years.

    Measured: 3 years follow-up

  7. 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.

    We will determine whether serum concentrations of SAA at the time of diagnosis of intrathoracic sarcoidosis correlate with the need for recent/ongoing therapy in patients, assessed at a 3-year follow-up.

    Measured: 3 years follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2023
  2. Study start1 Jan 2014
  3. Primary completion1 Aug 2018
  4. Study completion1 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05811962
Sponsor's protocol ID
UMCLjubljanaPulmo
Acronym
SARCO
Status last verified
Mar 2023
First submitted
16 Mar 2023
Last updated
13 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18032765

  • 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.

    PubMed 19910611

  • 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.

    PubMed 33036432

  • 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.

    PubMed 32760396

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcoidosis, Pulmonary, run by University Medical Centre Ljubljana at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 4 years for patient enrollment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05811962, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.

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