xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05979454</url>
    </required_header>
    <id_info>
      <org_study_id>ABBAAS</org_study_id>
      <nct_id>NCT05979454</nct_id>
    </id_info>
    <brief_title>Value of KL-6 in Rheumatoid Arthritis-Associated ILD</brief_title>
    <official_title>Value of Krebs Von Den Lungen-6 Assay in Rheumatoid Artheritis-associated Interstitial Lung Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Evaluation of serum KL6 level in rheumatoid arthritis-associated interstitial lung disease&#xD;
        (RA-ILD).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Rheumatoid arthritis (RA) is one of the most common connective tissue diseases (CTD). Its&#xD;
        prevalence is increasing worldwide . It is responsible for a considerable number of hospital&#xD;
        visits in Egyptian Hospitals . Pumlonary involvement is common in rheumatoid arthritis (RA).&#xD;
        Interstitial lung disease associated rheumatoid arthritis (ILD-RA) is responsible for&#xD;
        significant morbidity and mortality .&#xD;
  &#xD;
        Krebs von den Lungen 6 (KL-6) is a mucin like glycoprotein that is found mainly on the&#xD;
        surface of type II pneumocytes as well as in bronchiolar epithelial cells . It has&#xD;
        chemotactic and anti-apoptotic action on fibroblasts , hence, it is considered as a marker of&#xD;
        pulmonary epithelial cell injury .&#xD;
  &#xD;
        Krebs von den Lungen-6 (KL6) has been found to be a valuable diagnostic tool in many&#xD;
        interstitial lung diseases. KL6 was found to be a valuable prognostic marker, as well as a&#xD;
        marker for disease severity in idiopathic pulmonary fibrosis (IPF) . KL6 was found useful as&#xD;
        well in predicting in-hospital mortality in patients with Acute exacerbation of interstitial&#xD;
        lung disease (AE-ILD) . KL-6 serum level can serve as a diagnostic marker for connective&#xD;
        tissue disease-associated interstitial lung disease (CTD-ILD). It can be used to monitor&#xD;
        effectiveness of medical treatment and patient response to pulse therapy . Its value in&#xD;
        Rheumatoid Arthritis-associated Interstitial Lung Disease (RA-ILD) has not yet been&#xD;
        adequately investigated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>KL-6</measure>
      <time_frame>one day</time_frame>
      <description>detect its serum level</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Spirometry</measure>
      <time_frame>one day</time_frame>
      <description>FEV1, FVC, FVC/FEV1 will be measured.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HRCT chest</measure>
      <time_frame>one day</time_frame>
      <description>It will be will be assessed by the radiologist to determine pulmonary involvement.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Rheumatoid Arthritis-Associated Interstitial Lung Disease</condition>
    <arm_group>
      <arm_group_label>Rheumatoid Arthritis-associated Interstitial Lung Disease</arm_group_label>
      <description>Krebs von den Lungen-6 (KL6)</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Krebs von den Lungen-6 (KL6)</intervention_name>
      <description>KL-6 concentration will be measured using Sandwich ELISA technique (SinoGene Clone Biotech, China).</description>
      <arm_group_label>Rheumatoid Arthritis-associated Interstitial Lung Disease</arm_group_label>
      <other_name>Spirometry</other_name>
      <other_name>HRCT Chest</other_name>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        serum sample&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          all patients have rheumatoid arthritis-associated interstitial lung disease&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Diagnosis of RA will be based on American College of Rheumatology/European League against&#xD;
          Rheumatism (ACR-EULAR) classification criteria 2010.&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  all patients have rheumatoid arthritis-associated interstitial lung disease&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with any evidence of infection will be excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Safaa A Eid, Fellow</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Safaa A Eid, Fellow</last_name>
      <phone>+20 01002569966</phone>
      <email>safaa_gayed@aun.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Safaa A Eid</name>
        <address>
          <city>Assiut</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Safaa A Eid, Fellow</last_name>
        <phone>01002569966</phone>
        <email>safaa_gayed@aun.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>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.</citation>
      <PMID>36068354</PMID>
    </reference>
    <reference>
      <citation>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. Erratum In: Immunol Invest. 2022 Aug;51(6):1920.</citation>
      <PMID>29336618</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>20851924</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>24590021</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>8194900</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>9376125</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>33914762</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>35081277</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>35318424</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>31915006</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>20872595</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>31613151</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Safaa Abd El-gayed Eid</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Arthritis</mesh_term>
      <mesh_term>Arthritis, Rheumatoid</mesh_term>
      <mesh_term>Lung Diseases</mesh_term>
      <mesh_term>Lung Diseases, Interstitial</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05979454
  org study id: ABBAAS
  nct id: NCT05979454
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Evaluation of serum KL6 level in rheumatoid arthritis-associated interstitial lung disease
        (RA-ILD).
  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.
  observational model: Case-Only
  time perspective: Prospective
  measure: KL-6
  time frame: one day
  description: detect its serum level
  measure: Spirometry
  time frame: one day
  description: FEV1, FVC, FVC/FEV1 will be measured.
  measure: HRCT chest
  time frame: one day
  description: It will be will be assessed by the radiologist to determine pulmonary involvement.
  arm group label: Rheumatoid Arthritis-associated Interstitial Lung Disease
  description: Krebs von den Lungen-6 (KL6)
  intervention type: Diagnostic Test
  intervention name: Krebs von den Lungen-6 (KL6)
  description: KL-6 concentration will be measured using Sandwich ELISA technique (SinoGene Clone Biotech, China).
  arm group label: Rheumatoid Arthritis-associated Interstitial Lung Disease
  other name: Spirometry
  other name: HRCT Chest
  serum sample
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Safaa A Eid, Fellow
  role: Principal Investigator
  affiliation: Assiut University
  last name: Safaa A Eid, Fellow
  phone: +20 01002569966
  email: safaa_gayed@aun.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  citation: 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: 36068354
  citation: 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. Erratum In: Immunol Invest. 2022 Aug;51(6):1920.
  PMID: 29336618
  citation: 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: 20851924
  citation: 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: 24590021
  citation: 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: 8194900
  citation: 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: 9376125
  citation: 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: 33914762
  citation: 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: 35081277
  citation: 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: 35318424
  citation: 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: 31915006
  citation: 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: 20872595
  citation: 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: 31613151
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Safaa Abd El-gayed Eid
  investigator title: Principal investigator
  mesh term: Arthritis
  mesh term: Arthritis, Rheumatoid
  mesh term: Lung Diseases
  mesh term: Lung Diseases, Interstitial