NCT05979454|Unknown
Value of KL-6 in Rheumatoid Arthritis-Associated ILD
Value of Krebs Von Den Lungen-6 Assay in Rheumatoid Artheritis-associated Interstitial Lung Disease
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Value of Krebs Von Den Lungen-6 Assay in Rheumatoid Artheritis-associated Interstitial Lung Disease
Sponsor study identifier
observational
80
1 country
1
Study Start
January 1, 2023
Actual (reported)Primary Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Evaluation of serum KL6 level in rheumatoid arthritis-associated interstitial lung disease (RA-ILD).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2023
Actual (reported)July 28, 2023
Actual (reported)August 7, 2023
Actual (reported)December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
KL-6
detect its serum level
one day
Spirometry
one day
HRCT chest
one day
Krebs von den Lungen-6 (KL6)
KL-6 concentration will be measured using Sandwich ELISA technique (SinoGene Clone Biotech, China).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
all patients have rheumatoid arthritis-associated interstitial lung disease
Safaa A Eid
Asyut, Egypt
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.
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.
serum sample
Safaa A Eid, Fellow
Assiut University
First Submitted
July 28, 2023
First Posted
August 7, 2023
Study Start
January 1, 2023
Actual (reported)Primary Completion
December 2023
Estimated (date passed)Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 2, 2023
Record last verified: 2023-11
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Source: ClinicalTrials.gov.
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