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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • Lung ultrasound

    Diagnostic test

    Lung Ultrasound, 14 point protocol

  • GDF-15 level (ELISA)

    Diagnostic test

    Serum sample will be collected and ELISA test will be conducted

  • CT scan

    Diagnostic test

    High resolution CT of the lungs

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Rheumatoid arthritis patients3 interventions
Group B: Systemic Sclerosis patients3 interventions

Trial outcomes

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

Time frame
Baseline

Secondary outcomes

1

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

Time frame
Baseline
2

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

Time frame
Baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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