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Value of KL-6 in Rheumatoid Arthritis-Associated ILD

Value of Krebs Von Den Lungen-6 Assay in Rheumatoid Artheritis-associated Interstitial Lung Disease

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05979454
Enrollment
80
Registered
2023-08-07
Start date
2023-01-01
Completion date
2023-12-31
Last updated
2023-11-02

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

Conditions

Rheumatoid Arthritis-Associated Interstitial Lung Disease

Brief summary

Evaluation of serum KL6 level in rheumatoid arthritis-associated interstitial lung disease (RA-ILD).

Detailed description

Rheumatoid arthritis (RA) is one of the most common connective tissue diseases (CTD). Its prevalence is increasing worldwide . It is responsible for a considerable number of hospital visits in Egyptian Hospitals . Pumlonary involvement is common in rheumatoid arthritis (RA). Interstitial lung disease associated rheumatoid arthritis (ILD-RA) is responsible for significant morbidity and mortality . Krebs von den Lungen 6 (KL-6) is a mucin like glycoprotein that is found mainly on the surface of type II pneumocytes as well as in bronchiolar epithelial cells . It has chemotactic and anti-apoptotic action on fibroblasts , hence, it is considered as a marker of pulmonary epithelial cell injury . Krebs von den Lungen-6 (KL6) has been found to be a valuable diagnostic tool in many interstitial lung diseases. KL6 was found to be a valuable prognostic marker, as well as a marker for disease severity in idiopathic pulmonary fibrosis (IPF) . KL6 was found useful as well in predicting in-hospital mortality in patients with Acute exacerbation of interstitial lung disease (AE-ILD) . KL-6 serum level can serve as a diagnostic marker for connective tissue disease-associated interstitial lung disease (CTD-ILD). It can be used to monitor effectiveness of medical treatment and patient response to pulse therapy . Its value in Rheumatoid Arthritis-associated Interstitial Lung Disease (RA-ILD) has not yet been adequately investigated.

Interventions

DIAGNOSTIC_TESTKrebs von den Lungen-6 (KL6)

KL-6 concentration will be measured using Sandwich ELISA technique (SinoGene Clone Biotech, China).

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Diagnosis of RA will be based on American College of Rheumatology/European League against Rheumatism (ACR-EULAR) classification criteria 2010. Inclusion Criteria: * all patients have rheumatoid arthritis-associated interstitial lung disease

Exclusion criteria

* Patients with any evidence of infection will be excluded.

Design outcomes

Primary

MeasureTime frameDescription
KL-6one daydetect its serum level

Secondary

MeasureTime frameDescription
Spirometryone dayFEV1, FVC, FVC/FEV1 will be measured.
HRCT chestone dayIt will be will be assessed by the radiologist to determine pulmonary involvement.

Countries

Egypt

Contacts

Primary ContactSafaa A Eid, Fellow
safaa_gayed@aun.edu.eg+20 01002569966

Outcome results

None listed

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