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Rheumatoid Arthritis-Associated Interstitial Lung DiseaseNCT05979454

Value of KL-6 in Rheumatoid Arthritis-Associated ILD

An observational study of Rheumatoid Arthritis-Associated Interstitial Lung Disease, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Evaluation of serum KL6 level in rheumatoid arthritis-associated interstitial lung disease (RA-ILD). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Krebs von den Lungen-6 (KL6)
How many people
80 participants
Where
1 siteEgypt
Study dates
1 Jan 2023to Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: all patients have rheumatoid arthritis-associated interstitial lung disease

Who may be able to join

  • all patients have rheumatoid arthritis-associated interstitial lung disease

Who cannot join

  • Patients with any evidence of infection will be excluded.

Trial locations and contacts

1 site in 1 country.

Safaa A Eid, Fellow contact

+20 01002569966

safaa_gayed@aun.edu.eg

Egypt1 site, 1 recruiting

  • Safaa A Eid

    Asyut

    Safaa A Eid, Fellow, 01002569966, safaa_gayed@aun.edu.eg

    Ahmed A. Hafez, Lecturer

    Recruiting

Other trials in Egypt

About this study

Official title: 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).

Read the 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.

Being tested
Krebs von den Lungen-6 (KL6)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Krebs von den Lungen-6 (KL6)Diagnostic test

    Also called Spirometry, HRCT Chest

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

Study groups in NCT05979454
Study groupRoleWhat they receive
Rheumatoid Arthritis-associated Interstitial Lung DiseaseKrebs von den Lungen-6 (KL6)
Receives: Diagnostic Test: Krebs von den Lungen-6 (KL6)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. KL-6

    detect its serum level

    Measured: one day

Secondary outcomes (2)

  1. Spirometry

    FEV1, FVC, FVC/FEV1 will be measured.

    Measured: one day

  2. HRCT chest

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

    Measured: one day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2023
  2. Study start1 Jan 2023
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05979454
Sponsor's protocol ID
ABBAAS
Status last verified
Nov 2023
First submitted
28 Jul 2023
Last updated
2 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36068354

  • 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.

    PubMed 29336618

  • Olson AL, Swigris JJ, Sprunger DB, Fischer A, Fernandez-Perez ER, Solomon J, Murphy J, Cohen M, Raghu G, Brown KK. Rheumatoid arthritis-interstitial lung disease-associated mortality. Am J Respir Crit Care Med. 2011 Feb 1;183(3):372-8. doi: 10.1164/rccm.201004-0622OC. Epub 2010 Sep 17.

    PubMed 20851924

  • Doyle TJ, Lee JS, Dellaripa PF, Lederer JA, Matteson EL, Fischer A, Ascherman DP, Glassberg MK, Ryu JH, Danoff SK, Brown KK, Collard HR, Rosas IO. A roadmap to promote clinical and translational research in rheumatoid arthritis-associated interstitial lung disease. Chest. 2014 Mar 1;145(3):454-463. doi: 10.1378/chest.13-2408.

    PubMed 24590021

  • Kohno N, Inoue Y, Hamada H, Fujioka S, Fujino S, Yokoyama A, Hiwada K, Ueda N, Akiyama M. Difference in sero-diagnostic values among KL-6-associated mucins classified as cluster 9. Int J Cancer Suppl. 1994;8:81-3. doi: 10.1002/ijc.2910570717.

    PubMed 8194900

  • Hirasawa Y, Kohno N, Yokoyama A, Inoue Y, Abe M, Hiwada K. KL-6, a human MUC1 mucin, is chemotactic for human fibroblasts. Am J Respir Cell Mol Biol. 1997 Oct;17(4):501-7. doi: 10.1165/ajrcmb.17.4.2253.

    PubMed 9376125

  • Arnold DT, Donald C, Lyon M, Hamilton FW, Morley AJ, Attwood M, Dipper A, Barratt SL. Krebs von den Lungen 6 (KL-6) as a marker for disease severity and persistent radiological abnormalities following COVID-19 infection at 12 weeks. PLoS One. 2021 Apr 29;16(4):e0249607. doi: 10.1371/journal.pone.0249607. eCollection 2021.

    PubMed 33914762

  • Jiang D, Xiao H, Dong R, Geng J, Xie B, Ren Y, Dai H. Krebs von den Lungen-6 levels in untreated idiopathic pulmonary fibrosis. Clin Respir J. 2022 Mar;16(3):234-243. doi: 10.1111/crj.13475. Epub 2022 Jan 26.

    PubMed 35081277

  • Choi MG, Choi SM, Lee JH, Yoon JK, Song JW. Changes in blood Krebs von den Lungen-6 predict the mortality of patients with acute exacerbation of interstitial lung disease. Sci Rep. 2022 Mar 22;12(1):4916. doi: 10.1038/s41598-022-08965-9.

    PubMed 35318424

  • Ma H, Lu J, Song Y, Wang H, Yin S. The value of serum Krebs von den lungen-6 as a diagnostic marker in connective tissue disease associated with interstitial lung disease. BMC Pulm Med. 2020 Jan 8;20(1):6. doi: 10.1186/s12890-019-1043-z.

    PubMed 31915006

  • Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.

    PubMed 20872595

  • Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.

    PubMed 31613151

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis-Associated Interstitial Lung Disease, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Safaa A Eid, Fellow (+20 01002569966, safaa_gayed@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

KL-6 (time frame: one day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05979454, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.

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