Value of KL-6 in Rheumatoid Arthritis-Associated ILD

November 1, 2023 updated by: Safaa Abd El-gayed Eid, Assiut University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Safaa A Eid
        • Contact:
        • Principal Investigator:
          • Ahmed A. Hafez, Lecturer
        • Principal Investigator:
          • Sayed H. Ahmed, Lecturer
        • Principal Investigator:
          • Nada O. Abdelhamed, Lecturer
        • Principal Investigator:
          • Mohamed G. Abdelrahman, Lecturer
        • Principal Investigator:
          • Safaa A. Eid, Fellow

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

all patients have rheumatoid arthritis-associated interstitial lung disease

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KL-6
Time Frame: one day
detect its serum level
one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spirometry
Time Frame: one day
FEV1, FVC, FVC/FEV1 will be measured.
one day
HRCT chest
Time Frame: one day
It will be will be assessed by the radiologist to determine pulmonary involvement.
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

July 28, 2023

First Submitted That Met QC Criteria

July 28, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABBAAS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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