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/NCT05980728</url>
    </required_header>
    <id_info>
      <org_study_id>JSPH cohort</org_study_id>
      <nct_id>NCT05980728</nct_id>
    </id_info>
    <brief_title>Connective Tissue Disease Patients With Pulmonary Hypertension</brief_title>
    <official_title>The Prognostic Value of Biomarker in Connective Tissue Disease Patients With Pulmonary Hypertension</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The First Affiliated Hospital with Nanjing Medical 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>
        Adult patients with suspected or confirmed Connective Tissue Disease Patients (CTD)With&#xD;
        Pulmonary Hypertension(PH)will be recruited. Patients will be approached, consented, have&#xD;
        baseline demographics, diagnostics and disease activity measures recorded, and blood taken.&#xD;
        The collection of data and biological material will mirror usual clinical practice as far as&#xD;
        possible. Subjects will ideally attend further visits at 3, 6 and 12 months to have bloods&#xD;
        taken, outcome measures recorded and questionnaires completed.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2030</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2027</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>20 Years</target_duration>
    <primary_outcome>
      <measure>Death</measure>
      <time_frame>30 years</time_frame>
      <description>number of participants with All cause death</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Clinical worsening</measure>
      <time_frame>30 years</time_frame>
      <description>number of participants with Hospitalization for worsening pulmonary arterial hypertension(PAH),lung or heart/lung transplant) or unsatisfactory long-term clinical response (the 6-minute walk distance decreased &gt; 15% from baseline and World Health Organization(WHO) functional class III/IV symptoms assessed at two clinic visits separated by &gt; 6 months after sufficient PAH targeted drug treatment.</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Connective Tissue Diseases</condition>
    <condition>Pulmonary Hypertension</condition>
    <arm_group>
      <arm_group_label>Connective Tissue Disease Patients With Pulmonary Hypertension</arm_group_label>
      <description>Connective Tissue Disease Patients With Pulmonary Hypertension</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Connective Tissue Disease Patients Without Pulmonary Hypertension</arm_group_label>
      <description>Connective Tissue Disease Patients Without Pulmonary Hypertension</description>
    </arm_group>
    <arm_group>
      <arm_group_label>healthy</arm_group_label>
      <description>healthy people</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No Intervention</intervention_name>
      <description>No Intervention</description>
      <arm_group_label>Connective Tissue Disease Patients With Pulmonary Hypertension</arm_group_label>
      <arm_group_label>Connective Tissue Disease Patients Without Pulmonary Hypertension</arm_group_label>
      <arm_group_label>healthy</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        DNA RNA Peripheral blood mononuclear cells, Serum, Plasma, Urine,Stool&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Connective Tissue Disease Patients With Pulmonary Hypertension&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Definite diagnosis of CTD included Systemic lupus erythematosus（SLE） diagnosed&#xD;
               according to the 2019 The European Alliance of Associations for Rheumatology（EULAR）&#xD;
               criteria, primary Sjogren's syndrome (pSS) defined according to the 2016 American&#xD;
               College of Rheumatology(ACR) criteria, Systemic Sclerosis(SSc) defined according to&#xD;
               the 2013 ACR criteria, mixed connective tissue disease (MCTD) defined by Sharp&#xD;
               criteria, and Rheumatoid Arthritis(RA) defined according 2010 ACR criteria of two or&#xD;
               more CTD at the same time were defined as having overlap syndrome (OS). Patients who&#xD;
               had clinical and serological manifestations suggestive of systemic autoimmune diseases&#xD;
               but did not fulfil the classification criteria for CTD were defined as having&#xD;
               undifferentiated CTD (UCTD).&#xD;
  &#xD;
            -  PAH was diagnosed by right heart catheterization was defined as mean Pulmonary Artery&#xD;
               Pressure (mPAP)&gt;20 Millimeters of mercury（mmHg）, Pulmonary Artery Wedge&#xD;
               Pressure（PAWP）≤15mmHg, Pulmonary Vascular Resistance（PVR）&gt;2 Wood&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  significant interstitial lung disease or chronic obstructive pulmonary disease;&#xD;
  &#xD;
            -  left heart disease or congenital heart disease associated with pulmonary hypertension;&#xD;
  &#xD;
            -  chronic thromboembolic pulmonary hypertension;&#xD;
  &#xD;
            -  portal hypertension;&#xD;
  &#xD;
            -  drug or toxin exposure;&#xD;
  &#xD;
            -  HIV infection;&#xD;
  &#xD;
            -  any other diseases known to be associated with PAH;&#xD;
  &#xD;
            -  age&lt;18 years.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Qiang Wang, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Qiang Wang, MD</last_name>
      <phone>+862568307588</phone>
      <email>jerrytortoise@163.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>prognosis , biomarker, pulmonary hypertension</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension, Pulmonary</mesh_term>
      <mesh_term>Hypertension</mesh_term>
      <mesh_term>Connective Tissue Diseases</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/NCT05980728
  org study id: JSPH cohort
  nct id: NCT05980728
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Adult patients with suspected or confirmed Connective Tissue Disease Patients (CTD)With
        Pulmonary Hypertension(PH)will be recruited. Patients will be approached, consented, have
        baseline demographics, diagnostics and disease activity measures recorded, and blood taken.
        The collection of data and biological material will mirror usual clinical practice as far as
        possible. Subjects will ideally attend further visits at 3, 6 and 12 months to have bloods
        taken, outcome measures recorded and questionnaires completed.
  observational model: Cohort
  time perspective: Prospective
  measure: Death
  time frame: 30 years
  description: number of participants with All cause death
  measure: Clinical worsening
  time frame: 30 years
  description: number of participants with Hospitalization for worsening pulmonary arterial hypertension(PAH),lung or heart/lung transplant) or unsatisfactory long-term clinical response (the 6-minute walk distance decreased > 15% from baseline and World Health Organization(WHO) functional class III/IV symptoms assessed at two clinic visits separated by > 6 months after sufficient PAH targeted drug treatment.
  arm group label: Connective Tissue Disease Patients With Pulmonary Hypertension
  description: Connective Tissue Disease Patients With Pulmonary Hypertension
  arm group label: Connective Tissue Disease Patients Without Pulmonary Hypertension
  description: Connective Tissue Disease Patients Without Pulmonary Hypertension
  arm group label: healthy
  description: healthy people
  intervention type: Other
  intervention name: No Intervention
  description: No Intervention
  arm group label: Connective Tissue Disease Patients With Pulmonary Hypertension
  arm group label: Connective Tissue Disease Patients Without Pulmonary Hypertension
  arm group label: healthy
  DNA RNA Peripheral blood mononuclear cells, Serum, Plasma, Urine,Stool
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Qiang Wang, MD
  role: Principal Investigator
  affiliation: The First Affiliated Hospital with Nanjing Medical University
  last name: Qiang Wang, MD
  phone: +862568307588
  email: jerrytortoise@163.com
  responsible party type: Sponsor
  mesh term: Hypertension, Pulmonary
  mesh term: Hypertension
  mesh term: Connective Tissue Diseases
  sharing ipd: No