Combined Growth Differentiation Factor-15 (GDF-15) and Lung Ultrasound for ILD Screening in Rheumatoid Arthritis and Systemic Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
Interstitial lung disease (ILD) represents one of the most severe extra-articular and systemic manifestations of Rheumatoid Arthritis (RA) and Systemic Sclerosis (SSc). ILD significantly increases morbidity and remains a leading cause of mortality in both disease entities.
Accumulating evidence demonstrates a high prevalence of subclinical interstitial lung disease, occurring in up to 33% of patients with rheumatoid arthritis and 50% of patients with systemic sclerosis. Therefore, Early detection during this subclinical window is paramount to initiate timely immunomodulatory or antifibrotic therapies before irreversible fibrotic replacement occurs.
Although high-resolution computed tomography (HRCT) of the chest remains the gold standard for diagnosing interstitial lung disease, its high cost and associated radiation exposure restrict its utility as a routine screening tool for all patients, particularly in resource-limited settings. Consequently, there is a clinical demand for a validated, non-invasive, radiation-free, and cost-effective triage tool to screen populations at risk and identify those who genuinely require diagnostic HRCT evaluation.
Growth Differentiation Factor-15 (GDF-15), a stress-responsive cytokine belonging to the Transforming Growth Factor-beta (TGF-β) superfamily, has emerged as a novel systemic biomarker reflective of cellular stress, inflammation, and fibrogenesis . GDF-15 is significantly elevated in active systemic autoimmune conditions such as Behcet disease, Inflammatory bowel disease and Sjogren's disease . Importantly, GDF-15 is overexpressed in pulmonary epithelial cells during active fibrogenesis and serves as a key circulating biomarker in idiopathic pulmonary fibrosis as well as connective tissue disease-associated ILD and pulmonary hypertension.
As a cellular stress cytokine, serum GDF-15 reflects the distinct pathogenetic mechanisms driving ILD in each condition:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1- Adult patients (≥18 years) with confirmed diagnosis of RA or SSc.
排除标准
- •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).
研究组 & 干预措施
Rheumatoid arthritis patients
Either known to have ILD or not, Asymptomatic patients
干预措施: CT scan (Diagnostic Test)
Systemic Sclerosis patients
Either known to have ILD or not, Asymptomatic patients
干预措施: CT scan (Diagnostic Test)
Rheumatoid arthritis patients
Either known to have ILD or not, Asymptomatic patients
干预措施: Lung ultrasound (Diagnostic Test)
Rheumatoid arthritis patients
Either known to have ILD or not, Asymptomatic patients
干预措施: GDF-15 level (ELISA) (Diagnostic Test)
Systemic Sclerosis patients
Either known to have ILD or not, Asymptomatic patients
干预措施: Lung ultrasound (Diagnostic Test)
Systemic Sclerosis patients
Either known to have ILD or not, Asymptomatic patients
干预措施: GDF-15 level (ELISA) (Diagnostic Test)
结局指标
主要结局
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.
时间窗: Baseline
All patients will undergo combined GDF-15 + LUS to determine their diagnostic accuracy
次要结局
- 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.(Baseline)
- Evaluate the correlation between serum GDF-15 levels and the structural extent/severity of ILD on HRCT.(Baseline)
研究者
Sara Taher Mohamed Amin
Main investigator
Assiut University