NCT05979454

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 2, 2023

Status Verified

November 1, 2023

Enrollment Period

11 months

First QC Date

July 28, 2023

Last Update Submit

November 1, 2023

Conditions

Rheumatoid Arthritis-Associated Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

  • KL-6

    detect its serum level

    one day

Secondary Outcomes (2)

  • Spirometry

    one day

  • HRCT chest

    one day

Study Arms (1)

Rheumatoid Arthritis-associated Interstitial Lung Disease

Krebs von den Lungen-6 (KL6)

Diagnostic Test: Krebs von den Lungen-6 (KL6)

Interventions

Krebs von den Lungen-6 (KL6)DIAGNOSTIC_TEST

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

Also known as: Spirometry, HRCT Chest
Rheumatoid Arthritis-associated Interstitial Lung Disease

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients have rheumatoid arthritis-associated interstitial lung disease

You may qualify if:

  • all patients have rheumatoid arthritis-associated interstitial lung disease

You may not qualify if:

  • Patients with any evidence of infection will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Safaa A Eid

Asyut, Egypt

RECRUITING

Related Publications (12)

  • 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.

    PMID: 36068354BACKGROUND

  • 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.

    PMID: 29336618BACKGROUND

  • 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.

    PMID: 20851924BACKGROUND

  • 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.

    PMID: 24590021BACKGROUND

  • 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.

    PMID: 8194900BACKGROUND

  • 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.

    PMID: 9376125BACKGROUND

  • 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.

    PMID: 33914762BACKGROUND

  • 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.

    PMID: 35081277BACKGROUND

  • 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.

    PMID: 35318424BACKGROUND

  • 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.

    PMID: 31915006BACKGROUND

  • 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.

    PMID: 20872595BACKGROUND

  • 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.

    PMID: 31613151BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

serum sample

MeSH Terms

Interventions

Spirometry

Intervention Hierarchy (Ancestors)

Respiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Safaa A Eid, Fellow

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Safaa A Eid, Fellow

CONTACT

+20 01002569966safaa_gayed@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 28, 2023

First Posted

August 7, 2023

Study Start

January 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

November 2, 2023

Record last verified: 2023-11

Locations

EG(1)