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/NCT06029335</url>
    </required_header>
    <id_info>
      <org_study_id>35147-3/2020/ EÜIG</org_study_id>
      <secondary_id>05570-6/2023</secondary_id>
      <nct_id>NCT06029335</nct_id>
    </id_info>
    <brief_title>Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases</brief_title>
    <official_title>Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Pecs</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Pecs</source>
    <oversight_info>
      <has_dmc>No</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>
        Objectives: Systemic autoimmune diseases are chronic diseases characterized by chronic&#xD;
        inflammation, vasculopathy, and autoimmune phenomena. Several organ involvements are typical,&#xD;
        including the central nervous system. Formerly published investigations emphasize a mild&#xD;
        cognitive impairment affecting attention, memory, and complicated solution tasks. However,&#xD;
        these symptoms significantly impact patients' routines and quality of life. The study&#xD;
        examined the associations between cognitive impairment and clinical parameters regarding&#xD;
        systemic autoimmune diseases.&#xD;
  &#xD;
        Methods: General clinical data, some serum biomarkers including CCl-18, YKL-40, COMP, VEGF,&#xD;
        Galectin-3, and Pentraxin as well as results of functional, quality of life, and&#xD;
        neuropsychological measures, the Mini-Mental State Examination (MMSE), the Digit Span&#xD;
        Forward-Backward, the Trail making A, B and the Digit Symbol tests all were administered.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">September 1, 2020</start_date>
    <completion_date type="Anticipated">August 30, 2023</completion_date>
    <primary_completion_date type="Actual">October 10, 2022</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>Mini-mental State Examination</measure>
      <time_frame>12 months</time_frame>
      <description>Complex Cognitive measure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Functional Assessment of Chronic Illness Therapy F</measure>
      <time_frame>12 months</time_frame>
      <description>health-related quality of life measure</description>
    </primary_outcome>
    <number_of_groups>7</number_of_groups>
    <enrollment type="Actual">400</enrollment>
    <condition>Systemic Sclerosis</condition>
    <condition>Systemic Lupus Erythematosus</condition>
    <condition>Myopathies, Inflammatory</condition>
    <condition>Rheumatoid Arthritis</condition>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Diffuse cutaneous Systemic sclerosis</arm_group_label>
      <description>Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Limited cutaneous Systemic sclerosis</arm_group_label>
      <description>Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Primary Raynaud's</arm_group_label>
      <description>Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy</arm_group_label>
      <description>Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Rheumatoid arthritis</arm_group_label>
      <description>Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Inflammatory myopathies</arm_group_label>
      <description>Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Systemic lupus erythematosus</arm_group_label>
      <description>Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered.</description>
    </arm_group>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Investigations of serum samples for biomarkers&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Consecutive patients were enrolled into the study originating from the Rheumatology and&#xD;
          Immunology Department, Medical School, University of Pécs.&#xD;
  &#xD;
          Control healthy groups including consecutive sex and age-matched healthy individuals are&#xD;
          invited to participate.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Systemic autoimmune diseases&#xD;
  &#xD;
            -  Healthy individuals - as controls&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diseases of the central nervous system&#xD;
  &#xD;
            -  Presence of pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>University of Pécs, Department of Rheumatology and Immunology</name>
        <address>
          <city>Pécs</city>
          <zip>7632</zip>
          <country>Hungary</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Hungary</country>
    </location_countries>
    <reference>
      <citation>Olah C, Schwartz N, Denton C, Kardos Z, Putterman C, Szekanecz Z. Cognitive dysfunction in autoimmune rheumatic diseases. Arthritis Res Ther. 2020 Apr 15;22(1):78. doi: 10.1186/s13075-020-02180-5.</citation>
      <PMID>32293528</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 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 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Pecs</investigator_affiliation>
      <investigator_full_name>dr Varjú Cecília</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Myositis</mesh_term>
      <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
      <mesh_term>Scleroderma, Systemic</mesh_term>
      <mesh_term>Scleroderma, Diffuse</mesh_term>
      <mesh_term>Autoimmune Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Data are not publicly available due to ethical issues.</ipd_description>
    </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/NCT06029335
  org study id: 35147-3/2020/ EÜIG
  secondary id: 05570-6/2023
  nct id: NCT06029335
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Objectives: Systemic autoimmune diseases are chronic diseases characterized by chronic
        inflammation, vasculopathy, and autoimmune phenomena. Several organ involvements are typical,
        including the central nervous system. Formerly published investigations emphasize a mild
        cognitive impairment affecting attention, memory, and complicated solution tasks. However,
        these symptoms significantly impact patients' routines and quality of life. The study
        examined the associations between cognitive impairment and clinical parameters regarding
        systemic autoimmune diseases.
  
        Methods: General clinical data, some serum biomarkers including CCl-18, YKL-40, COMP, VEGF,
        Galectin-3, and Pentraxin as well as results of functional, quality of life, and
        neuropsychological measures, the Mini-Mental State Examination (MMSE), the Digit Span
        Forward-Backward, the Trail making A, B and the Digit Symbol tests all were administered.
  observational model: Cohort
  time perspective: Prospective
  measure: Mini-mental State Examination
  time frame: 12 months
  description: Complex Cognitive measure
  measure: The Functional Assessment of Chronic Illness Therapy F
  time frame: 12 months
  description: health-related quality of life measure
  arm group label: Diffuse cutaneous Systemic sclerosis
  description: Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered.
  arm group label: Limited cutaneous Systemic sclerosis
  description: Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered.
  arm group label: Primary Raynaud's
  description: Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered.
  arm group label: Healthy
  description: Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered.
  arm group label: Rheumatoid arthritis
  description: Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered.
  arm group label: Inflammatory myopathies
  description: Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered.
  arm group label: Systemic lupus erythematosus
  description: Physical examination, routine blood, immunoserology, and special biomarker laboratory examination. General health, functional, and quality of life questionnaires, and neuropsychological measures are administered.
  Investigations of serum samples for biomarkers
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Hungary
  citation: Olah C, Schwartz N, Denton C, Kardos Z, Putterman C, Szekanecz Z. Cognitive dysfunction in autoimmune rheumatic diseases. Arthritis Res Ther. 2020 Apr 15;22(1):78. doi: 10.1186/s13075-020-02180-5.
  PMID: 32293528
  responsible party type: Principal Investigator
  investigator affiliation: University of Pecs
  investigator full name: dr Varjú Cecília
  investigator title: Associate Professor
  mesh term: Myositis
  mesh term: Lupus Erythematosus, Systemic
  mesh term: Scleroderma, Systemic
  mesh term: Scleroderma, Diffuse
  mesh term: Autoimmune Diseases
  sharing ipd: No
  ipd description: Data are not publicly available due to ethical issues.