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Novel Biomarkers in Assessment of Interstitial Lung Disease Associated With Rheumatoid Arthritis Patients

Novel Biomarkers in Assessment of Interstitial Lung Disease Associated With Rheumatoid Arthritis Patients

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07003451
Enrollment
60
Registered
2025-06-04
Start date
2025-10-01
Completion date
2026-06-01
Last updated
2025-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung Disease, Rheumatoid Arthritis

Brief summary

\- Assess Krebs von den Lungen-6 (KL-6) and Calprotectin as novel biomarkers for diagnosis of ILD among Rheumatoid arthritis patients

Detailed description

Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized by small joint synovitis that is estimated to affect 0.3% to 1% of the global population. Extraarticular disease may occur in up to 50% of patients with RA, with pulmonary manifestations among the most common extraarticular features. Interstitial lung disease (ILD) clinically affects up to 10% of patients with RA and subclinically affects up to 40%. RA-ILD typically presents as a usual interstitial pneumonia (UIP) or nonspecific interstitial pneumonia pattern. Diagnosis requires a thorough evaluation, including laboratory and imaging studies; pulmonary function testing (PFT); medication review; occasionally, tissue histopathology; and frequently, multidisciplinary input. Prompt recognition of RA-ILD is crucial because it warrants close monitoring and often necessitates therapeutic alterations. Biomarkers are a promising area of investigation in RA-ILD because they have the potential to advance pathophysiologic understanding and elucidate therapeutic targets, improve disease identification and diagnostic accuracy, facilitate prognostication, and inform treatment decisions. Although imaging and histopathology have important roles that are unlikely to be replaced by biomarkers, they can be nonspecific in RA-ILD, can be impractical to obtain in certain settings, and cannot be scaled for population health efforts. Calprotectin belongs to the S-100 proteins produced by neutrophils, which likely contribute to idiopathic pulmonary fibrosis (IPF) pathogenesis. Calprotectin is a well-established biomarker in inflammatory bowel diseases.

Interventions

DIAGNOSTIC_TESTCalprotectin Level

Measurement of calprotectin level to presence and severity of ILD asessed via Warrick's score

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Confirmed diagnosis of Rheumatoid arthritis, age \> 18 years.

Exclusion criteria

* Patients who refuse to participate in the study, * Patients with evidence of worsening or exacerbation of RA over the previous 6 months, * concomitant diagnosis of an active neoplasia, or * patients who had previously received radiotherapy, * End organ failure.

Design outcomes

Primary

MeasureTime frameDescription
calprotectin level among rheumatoid arthritis patients with interstitial lung diseaseday 1calprotectin level among rheumatoid arthritis patients with interstitial lung disease

Countries

Egypt

Contacts

Primary Contactwaleed gamal elddin, ass. prof
waleedgamalddin@yahoo.com+201006519722
Backup Contactahmad shaddad, ass. prof
Shaddad_ahmad@aun.edu.eg+201111171930

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026