Rheumatoid Arthritis (RA)NCT07839221
Combined Growth Differentiation Factor-15 (GDF-15) and Lung Ultrasound for ILD Screening in Rheumatoid Arthritis and Systemic Sclerosis
An observational study of Rheumatoid Arthritis (RA) and Systemic Sclerosis (SSc), run by Assiut University.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Interstitial Lung Disease (ILD)
- What is being tested?
- Lung ultrasound, GDF-15 level (ELISA) and CT scan
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 1 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 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
Who may be able to join
- 1- Adult patients (≥18 years) with confirmed diagnosis of RA or SSc.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
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.
Read the detailed description
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:
RA-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.
SSc-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.
Concurrently, 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.
While 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.
- Being tested
- Lung ultrasound, GDF-15 level (ELISA), CT scan
- Keywords
- Rheumatoid arthritis, Systemic sclerosis, lung ultrasound, GDF-15 level, Interstitial lung diseases, High resolution CT, Lung fibrosis
- Medical subject headings
- Arthritis, Rheumatoid, Scleroderma, Systemic, Lung Diseases, Interstitial, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundDiagnostic test
Lung Ultrasound, 14 point protocol
GDF-15 level (ELISA)Diagnostic test
Serum sample will be collected and ELISA test will be conducted
CT scanDiagnostic test
High resolution CT of the lungs
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid arthritis patients | Either known to have ILD or not, Asymptomatic patients Receives: Diagnostic Test: Lung ultrasound; Diagnostic Test: GDF-15 level (ELISA); Diagnostic Test: CT scan | |
| Systemic Sclerosis patients | Either known to have ILD or not, Asymptomatic patients Receives: Diagnostic Test: Lung ultrasound; Diagnostic Test: GDF-15 level (ELISA); Diagnostic Test: CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (2)
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
Measured: Baseline
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start15 Oct 2026 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Taher Mohamed Amin, Assiut University
- Investigators
- Essam Ahmed Abda, Professor, Principal investigator, Professor of Rheumatology, Rehabilitation and Physical medicineMohammed Raouf Abd El-razik, Assistant Professor, Study director, Assistant professor of Rheumatology, Rehabilitation and physical medicineAmira Mostafa El-Sonbaty, Lecturer, Study director, Lecturer of Rheumatology, Rehabilitation and Physical medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839221
- Sponsor's protocol ID
- PhD Rheumatology thesis
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Growth Differentiation Factor-15 (GDF-15) and Lung Ultrasound for ILD Screening in Rheumatoid Arthritis and Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT07839221
- Acronym / sponsor ID
- PhD Rheumatology thesis
- Keywords
- Rheumatoid arthritis, Systemic sclerosis, lung ultrasound, GDF-15 level, Interstitial lung diseases, High resolution CT, Lung fibrosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
RA-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.
SSc-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.
Concurrently, 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.
While 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis patients | – | Diagnostic Test: Lung ultrasound, Diagnostic Test: GDF-15 level (ELISA), Diagnostic Test: CT scanEither known to have ILD or not, Asymptomatic patients |
| Systemic Sclerosis patients | – | Diagnostic Test: Lung ultrasound, Diagnostic Test: GDF-15 level (ELISA), Diagnostic Test: CT scanEither known to have ILD or not, Asymptomatic patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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
Key inclusion criteria (1 listed)
- 1- Adult patients (≥18 years) with confirmed diagnosis of RA or SSc.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung ultrasoundLung Ultrasound, 14 point protocol | Diagnostic test | Rheumatoid arthritis patients, Systemic Sclerosis patients |
| GDF-15 level (ELISA)Serum sample will be collected and ELISA test will be conducted | Diagnostic test | Rheumatoid arthritis patients, Systemic Sclerosis patients |
| CT scanHigh resolution CT of the lungs | Diagnostic test | Rheumatoid arthritis patients, Systemic Sclerosis patients |
Primary outcome
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.
Time frame: Baseline
All patients will undergo combined GDF-15 + LUS to determine their diagnostic accuracy
2 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.
Time frame: Baseline
Evaluate the correlation between serum GDF-15 levels and the structural extent/severity of ILD on HRCT.
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Essam Ahmed Abda, Professor principal investigator
Professor of Rheumatology, Rehabilitation and Physical medicine
Mohammed Raouf Abd El-razik, Assistant Professor study director
Assistant professor of Rheumatology, Rehabilitation and physical medicine
Amira Mostafa El-Sonbaty, Lecturer study director
Lecturer of Rheumatology, Rehabilitation and Physical medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis (RA) and Systemic Sclerosis (SSc), run by Assiut University.
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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Taher Amin, Assistant lecturer (00201111337547, sarataher.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.