[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657533":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":23,"studyPopulation":24,"armGroups":25,"interventions":36,"overallOfficials":50,"centralContacts":62,"locations":20,"responsibleParty":68,"collaborators":20,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":20,"eligibilityCriteria":76,"healthyVolunteers":73,"sex":77,"minAge":78,"maxAge":20,"enrollmentInfo":79,"targetDuration":20,"studyType":82,"phases":20,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":96,"whyStopped":20,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":20},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"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","Baseline",[14,17],{"measure":15,"description":16,"timeFrame":12},"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",{"measure":18,"description":19,"timeFrame":12},"Evaluate the correlation between serum GDF-15 levels and the structural extent\u002Fseverity of ILD on HRCT.","Level of GDF-15 will be correlated with CT findings",null,{"allocation":20,"interventionModel":20,"interventionModelDescription":20,"primaryPurpose":20,"observationalModel":6,"timePerspective":22,"maskingInfo":20},"CROSS_SECTIONAL","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.\n\nAccumulating 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.\n\nAlthough 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.\n\nGrowth 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.\n\nAs a cellular stress cytokine, serum GDF-15 reflects the distinct pathogenetic mechanisms driving ILD in each condition:\n\nRA-ILD: Mucosal citrullination and anti-CCP immune complex deposition 2022induce alveolar epithelial injury and inflammatory cytokine release. Here, elevated GDF-15 primarily reflects acute epithelial stress and immune-mediated inflammatory intensity.\n\nSSc-ILD: Microvascular damage and endothelial apoptosis trigger TGF-β signaling and myofibroblast expansion. Here, GDF-15 acts downstream of TGF-β, reflecting chronic endothelial ischemia and fibrogenesis.\n\nConcurrently, point-of-care Lung Ultrasound (LUS) has revolutionized bedside assessment in rheumatology. LUS detects interstitial pulmonary changes-specifically B-lines and pleural line irregularities-with exceptional sensitivity. Recent evidence highlights that LUS achieves remarkable diagnostic accuracy compared to HRCT in both RA-ILD and SSc-ILD.\n\nWhile GDF-15 reflects early molecular and cellular fibrotic activity and LUS identifies early structural lung affection, whether combining these two non-invasive modalities yields superior diagnostic accuracy for subclinical ILD screening compared to either modality alone remains unexplored. Combining a molecular circulating marker with a physical point-of-care imaging tool could establish a robust triage model for outpatient rheumatology clinics. Therefore, this is a diagnostic accuracy study to determine the outcomes of this combination.","All adult patients diagnosed as RA \"according to 2010 ACR\u002FEULAR classification criteria\" or SSc \"according to 2013 ACR\u002FEULAR 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",[26,33],{"label":27,"type":20,"description":28,"interventionNames":29},"Rheumatoid arthritis patients","Either known to have ILD or not, Asymptomatic patients",[30,31,32],"Diagnostic Test: Lung ultrasound","Diagnostic Test: GDF-15 level (ELISA)","Diagnostic Test: CT scan",{"label":34,"type":20,"description":28,"interventionNames":35},"Systemic Sclerosis patients",[30,31,32],[37,42,46],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":20},"DIAGNOSTIC_TEST","Lung ultrasound","Lung Ultrasound, 14 point protocol",[27,34],{"type":38,"name":43,"description":44,"armGroupLabels":45,"otherNames":20},"GDF-15 level (ELISA)","Serum sample will be collected and ELISA test will be conducted",[27,34],{"type":38,"name":47,"description":48,"armGroupLabels":49,"otherNames":20},"CT scan","High resolution CT of the lungs",[27,34],[51,55,59],{"name":52,"affiliation":53,"role":54},"Essam Ahmed Abda, Professor","Professor of Rheumatology, Rehabilitation and Physical medicine","PRINCIPAL_INVESTIGATOR",{"name":56,"affiliation":57,"role":58},"Mohammed Raouf Abd El-razik, Assistant Professor","Assistant professor of Rheumatology, Rehabilitation and physical medicine","STUDY_DIRECTOR",{"name":60,"affiliation":61,"role":58},"Amira Mostafa El-Sonbaty, Lecturer","Lecturer of Rheumatology, Rehabilitation and Physical medicine",[63],{"name":64,"role":65,"phone":66,"phoneExt":20,"email":67},"Sara Taher Amin, Assistant lecturer","CONTACT","00201111337547","sarataher.md@gmail.com",{"type":54,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Sara Taher Mohamed Amin","Main investigator","100657533","combined-gdf-15-and-lung-ultrasound-for-subclinical-ild-screening-in-rheumatoid-arthritis-and-systemic-sclerosis-100657533",false,"NCT07839221","Combined Growth Differentiation Factor-15 (GDF-15) and Lung Ultrasound for ILD Screening in Rheumatoid Arthritis and Systemic Sclerosis","Inclusion Criteria:\n\n1- Adult patients (≥18 years) with confirmed diagnosis of RA or SSc.\n\nExclusion Criteria:\n\n1. Active respiratory tract infection or acute exacerbation of pulmonary disease.\n2. Other causes of pulmonary fibrosis such as history of heavy smoking (\\>15 pack-years) or significant environmental\u002Foccupational exposure known to induce pulmonary fibrosis.\n3. Pre-existing primary chronic lung diseases (e.g., COPD, bronchial asthma, active tuberculosis, severe bronchiectasis).","ALL","18 Years",{"count":80,"type":81},110,"ESTIMATED","OBSERVATIONAL","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).\n\nThe main question it aims to answer is:\n\nDoes 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?\n\nParticipants 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.",[85,86,87],"Rheumatoid Arthritis (RA)","Systemic Sclerosis (SSc)","Interstitial Lung Disease (ILD)",[89,90,91,92,93,94,95],"Rheumatoid arthritis","Systemic sclerosis","lung ultrasound","GDF-15 level","Interstitial lung diseases","High resolution CT","Lung fibrosis","NOT_YET_RECRUITING","2026-09-23",{"date":99,"type":100},"2026-09-25","ACTUAL",{"date":102,"type":81},"2026-10-15",{"date":104,"type":81},"2028-12-01",{"name":5,"class":6}]