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/NCT06036537</url>
    </required_header>
    <id_info>
      <org_study_id>1stChongqingMU123</org_study_id>
      <nct_id>NCT06036537</nct_id>
    </id_info>
    <brief_title>Investigation on Risk Factors of Rheumatoid Arthritis Related Interstitial Lung Disease</brief_title>
    <official_title>Investigation on Risk Factors of Rheumatoid Arthritis Related Interstitial Lung Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>First Affiliated Hospital of Chongqing Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>First Affiliated Hospital of Chongqing Medical University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Rheumatoid arthritis (RA) is one of the most common autoimmune diseases, characterized by&#xD;
        chronic inflammatory bone and cartilage destruction. Although treatment including anti-tumor&#xD;
        necrosis factor (TNF) and interleukin-6 (IL-6) receptor antibodies has been successful, only&#xD;
        20% to 30% of patients have achieved complete remission. Interstitial lung disease (ILD) is a&#xD;
        common complication of rheumatoid arthritis (RA). Approximately 5-10% of RA patients have&#xD;
        clinically significant rheumatoid arthritis associated interstitial lung disease (RA-ILD),&#xD;
        with a mortality rate of 2-10 times that of RA-non ILD patients. The median survival after&#xD;
        diagnosis is between 3-8 years. Although there are multiple biomarkers for RA-ILD, such as&#xD;
        anti citrullinated protein antibody (ACPA), MUC5B mutant gene, KL-6, etc., none of these&#xD;
        biomarkers can reliably predict the disease and prognostic risk of RA-ILD. Therefore,&#xD;
        improving the prediction of RA complicated with ILD and exploring risk factors for the&#xD;
        progression and prognosis of RA-ILD can contribute to early diagnosis and treatment, and is&#xD;
        of great significance in preventing RA lung injury and death.&#xD;
  &#xD;
        This study aims to screen differential serum biomarkers between RA patients and RA-ILD&#xD;
        patients through prospective cohort studies, to explore whether these differential serum&#xD;
        biomarkers are a risk factor for RA patients complicated with ILD, and whether they affect&#xD;
        the clinical prognosis of RA-ILD patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">March 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Occurrence of interstitial lung disease</measure>
      <time_frame>2 years</time_frame>
      <description>Whether rheumatoid arthritis patients have occurred interstitial lung disease and the time of occurrence of interstitial lung disease</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">1200</enrollment>
    <condition>Rheumatoid Arthritis Associated Interstitial Lung Disease</condition>
    <arm_group>
      <arm_group_label>rheumatoid arthritis</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>diagnosis of Interstitial lung disease</intervention_name>
      <description>Serum marker detection，High resolution computed tomography scan</description>
      <arm_group_label>rheumatoid arthritis</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          rheumatoid arthritis patients&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          1. Diagnosis of rheumatoid arthritis patients based on the 2010 ACR/EULAR RA classification&#xD;
          criteria; 2. age ≥18 years; 3. Interstitial lung disease was diagnosed by lung high&#xD;
          resolution computed tomography (HRCT)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          1. age &lt;years; 2. Being treated with urate-lowering medications; 3. Other systemic/organ&#xD;
          specific autoimmune diseases other than rheumatoid arthritis (such as SLE, ANCA associated&#xD;
          vasculitis, pSS, SSc, myositis, etc.); 4.Tumor, pulmonary tuberculosis, glomerular&#xD;
          filtration rate less than 30ml/min/1.73m2&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Chongqing General Hospital</name>
        <address>
          <city>Chongqing</city>
          <state>Chongqing</state>
          <zip>401147</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>qiongwen hu, PhD</last_name>
        <phone>+86-023-63516483</phone>
        <email>huqiongwen1@sina.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>First Affiliated Hospital of Chongqing Medical University</investigator_affiliation>
      <investigator_full_name>Xiaocheng Cheng</investigator_full_name>
      <investigator_title>M.D.</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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06036537
  org study id: 1stChongqingMU123
  nct id: NCT06036537
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Rheumatoid arthritis (RA) is one of the most common autoimmune diseases, characterized by
        chronic inflammatory bone and cartilage destruction. Although treatment including anti-tumor
        necrosis factor (TNF) and interleukin-6 (IL-6) receptor antibodies has been successful, only
        20% to 30% of patients have achieved complete remission. Interstitial lung disease (ILD) is a
        common complication of rheumatoid arthritis (RA). Approximately 5-10% of RA patients have
        clinically significant rheumatoid arthritis associated interstitial lung disease (RA-ILD),
        with a mortality rate of 2-10 times that of RA-non ILD patients. The median survival after
        diagnosis is between 3-8 years. Although there are multiple biomarkers for RA-ILD, such as
        anti citrullinated protein antibody (ACPA), MUC5B mutant gene, KL-6, etc., none of these
        biomarkers can reliably predict the disease and prognostic risk of RA-ILD. Therefore,
        improving the prediction of RA complicated with ILD and exploring risk factors for the
        progression and prognosis of RA-ILD can contribute to early diagnosis and treatment, and is
        of great significance in preventing RA lung injury and death.
  
        This study aims to screen differential serum biomarkers between RA patients and RA-ILD
        patients through prospective cohort studies, to explore whether these differential serum
        biomarkers are a risk factor for RA patients complicated with ILD, and whether they affect
        the clinical prognosis of RA-ILD patients.
  observational model: Cohort
  time perspective: Prospective
  measure: Occurrence of interstitial lung disease
  time frame: 2 years
  description: Whether rheumatoid arthritis patients have occurred interstitial lung disease and the time of occurrence of interstitial lung disease
  arm group label: rheumatoid arthritis
  intervention type: Diagnostic Test
  intervention name: diagnosis of Interstitial lung disease
  description: Serum marker detection，High resolution computed tomography scan
  arm group label: rheumatoid arthritis
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: First Affiliated Hospital of Chongqing Medical University
  investigator full name: Xiaocheng Cheng
  investigator title: M.D.
  mesh term: Arthritis
  mesh term: Arthritis, Rheumatoid
  mesh term: Lung Diseases
  mesh term: Lung Diseases, Interstitial
  sharing ipd: No