Value of KL-6 in Rheumatoid Arthritis-Associated ILD

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05979454
Collaborator
(none)
80
1
11
7.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Krebs von den Lungen-6 (KL6)

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Value of Krebs Von Den Lungen-6 Assay in Rheumatoid Artheritis-associated Interstitial Lung Disease
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Rheumatoid Arthritis-associated Interstitial Lung Disease

Krebs von den Lungen-6 (KL6)

Diagnostic Test: Krebs von den Lungen-6 (KL6)
KL-6 concentration will be measured using Sandwich ELISA technique (SinoGene Clone Biotech, China).
Other Names:
  • Spirometry
  • HRCT Chest
  • Outcome Measures

    Primary Outcome Measures

    1. KL-6 [one day]

      detect its serum level

    Secondary Outcome Measures

    1. Spirometry [one day]

      FEV1, FVC, FVC/FEV1 will be measured.

    2. HRCT chest [one day]

      It will be will be assessed by the radiologist to determine pulmonary involvement.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Safaa A Eid Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Safaa A Eid, Fellow, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Safaa Abd El-gayed Eid, Principal investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05979454
    Other Study ID Numbers:
    • ABBAAS
    First Posted:
    Aug 7, 2023
    Last Update Posted:
    Aug 9, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 9, 2023