About this trial
The goal of this observational study is to detect the lung affection in patients with Rheumatoid Arthritis(RA) or Systemic sclerosis (SSc) before appearance of symptoms(Subclinical) using combined diagnostic modalities which are Lung Ultrasound and a blood marker called Growth Differentiation Factor-15 (GDF-15).
The main question it aims to answer is:
Does the combination of these 2 modalities have the diagnostic accuracy similar to the gold standard test which is High Resolution Computed Tomography (HRCT) of the Lungs? Does this combination have the potential to become a validated screening tool?
Participants will be in 2 groups: the RA group and the SSc group, each will have the diagnostic combination and a reference HRCT for comparison of results.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Active respiratory tract infection or acute exacerbation of pulmonary disease.
Other causes of pulmonary fibrosis such as history of heavy smoking (>15 pack-years) or significant environmental/occupational exposure known to induce pulmonary fibrosis.
Pre-existing primary chronic lung diseases (e.g., COPD, bronchial asthma, active tuberculosis, severe bronchiectasis).
Trial population
All adult patients diagnosed as RA "according to 2010 ACR/EULAR classification criteria" or SSc "according to 2013 ACR/EULAR classification criteria", either known to be complicated with ILD or not, are recruited from inpatient and outpatient clinic of Rheumatology and Rehabilitation department of Assiut University hospital
Trial design
Other
Cross-sectional
Treatments tested in this trial
Lung ultrasound
Diagnostic testLung Ultrasound, 14 point protocol
GDF-15 level (ELISA)
Diagnostic testSerum sample will be collected and ELISA test will be conducted
CT scan
Diagnostic testHigh resolution CT of the lungs
Treatment groups
Trial outcomes
Primary outcomes
Determine the overall diagnostic accuracy (Sensitivity, Specificity, positive and negative predictive values) of combined GDF-15 + LUS compared to HRCT in screening for subclinical ILD in RA and SSc patients.
All patients will undergo combined GDF-15 + LUS to determine their diagnostic accuracy
Secondary outcomes
Compare baseline serum GDF-15 levels between RA-ILD and SSc-ILD cohorts to assess whether differing underlying pathogenetic mechanisms influence circulating GDF-15 concentrations and its diagnostic cut-off values.
Cut-off values of GDF-15 will be determined for each group
Evaluate the correlation between serum GDF-15 levels and the structural extent/severity of ILD on HRCT.
Level of GDF-15 will be correlated with CT findings
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: