Combined Growth Differentiation Factor-15 (GDF-15) and Lung Ultrasound for ILD Screening in Rheumatoid Arthritis and Systemic Sclerosis

NCT07839221 | Not Yet Recruiting DMC

• 1 other identifier: PhD Rheumatology thesis
• Study Type: observational
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Rheumatoid Arthritis (RA); Systemic Sclerosis (SSc); Interstitial Lung Disease (ILD)

Keywords

Rheumatoid arthritis; Systemic sclerosis; lung ultrasound; GDF-15 level; Interstitial lung diseases; High resolution CT; Lung fibrosis

Outcome Measures

Primary Outcomes (1)

• 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

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.

  Baseline

• Evaluate the correlation between serum GDF-15 levels and the structural extent/severity of ILD on HRCT.

  Baseline

Study Arms (2)

Rheumatoid arthritis patients

Either known to have ILD or not, Asymptomatic patients

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

Diagnostic Test: Lung ultrasound; Diagnostic Test: GDF-15 level (ELISA); Diagnostic Test: CT scan

Interventions

Lung ultrasound DIAGNOSTIC_TEST

Lung Ultrasound, 14 point protocol

Rheumatoid arthritis patients; Systemic Sclerosis patients

GDF-15 level (ELISA) DIAGNOSTIC_TEST

Serum sample will be collected and ELISA test will be conducted

Rheumatoid arthritis patients; Systemic Sclerosis patients

CT scan DIAGNOSTIC_TEST

High resolution CT of the lungs

Rheumatoid arthritis patients; Systemic Sclerosis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• Adult patients (≥18 years) with confirmed diagnosis of RA or SSc.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assiut University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum sample

MeSH Terms

Conditions

Arthritis, Rheumatoid; Scleroderma, Systemic; Lung Diseases, Interstitial; Pulmonary Fibrosis

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Essam Ahmed Abda, Professor

  Professor of Rheumatology, Rehabilitation and Physical medicine

  PRINCIPAL INVESTIGATOR

• Mohammed Raouf Abd El-razik, Assistant Professor

  Assistant professor of Rheumatology, Rehabilitation and physical medicine

  STUDY DIRECTOR

• Amira Mostafa El-Sonbaty, Lecturer

  Lecturer of Rheumatology, Rehabilitation and Physical medicine

  STUDY DIRECTOR

Central Study Contacts

Sara Taher Amin, Assistant lecturer

CONTACT

00201111337547; sarataher.md@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Main investigator

Study Record Dates

• First Submitted: September 19, 2026
• First Posted: September 24, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09