Value of KL-6 in Rheumatoid Arthritis-Associated ILD | NCT05979454

Studies
Value of KL-6 in Rheumatoid Arthritis-Associated ILD

NCT05979454

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Nov 2, 2023Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Rheumatoid Arthritis-Associated Interstitial Lung Disease

Interventions

Krebs von den Lungen-6 (KL6)

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Jul 28, 2023

First Submission Date that Met QC Criteria

Jul 28, 2023

First Posted Date

Aug 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2023

Last Update Posted Date

Nov 2, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Safaa Abd El-gayed Eid, Principal investigator, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rheumatoid Arthritis-associated Interstitial Lung Disease		Krebs von den Lungen-6 (KL6)	Diagnostic Test: Krebs von den Lungen-6 (KL6)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Krebs von den Lungen-6 (KL6)	Diagnostic Test	KL-6 concentration will be measured using Sandwich ELISA technique (SinoGene Clone Biotech, China).	Rheumatoid Arthritis-associated Interstitial Lung Disease

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

all patients have rheumatoid arthritis-associated interstitial lung disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Safaa A Eid, Fellow	Contact	+20 01002569966		safaa_gayed@aun.edu.eg

Overall Officials

Name	Affiliation	Role
Safaa A Eid, Fellow	Assiut University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Safaa A Eid	Recruiting	Asyut			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36068354	Background	Finckh A, Gilbert B, Hodkinson B, Bae SC, Thomas R, Deane KD, Alpizar-Rodriguez D, Lauper K. Global epidemiology of rheumatoid arthritis. Nat Rev Rheumatol. 2022 Oct;18(10):591-602. doi: 10.1038/s41584-022-00827-y. Epub 2022 Sep 6.
29336618	Background	Sakr BR, Elfishawi MM, ElArousy MH, Hatw AK, AbdulKarim AN, Tammam AB, Kotp AN, Hamed ME, Genedy IE, Desouky EDE, Nawito ZO. Rheumatoid arthritis: A single-center Egyptian experience. Immunol Invest. 2018 Apr;47(3):293-302. doi: 10.1080/08820139.2018.1425700. Epub 2018 Jan 16.

ID	Term
D012129	Respiratory Function Tests
D003948	Diagnostic Techniques, Respiratory System
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis