<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/NCT03303508</url>
  </required_header>
  <id_info>
    <org_study_id>CLIFT &amp; ELISA</org_study_id>
    <nct_id>NCT03303508</nct_id>
  </id_info>
  <brief_title>Measurement of Anti-dsDNA by Both CLIFT &amp; ELISA</brief_title>
  <official_title>Detection Of Anti-Double Stranded Deoxyribonucleic Acid Antibodies In Autoimmune Rheumatic Diseases: Comparison Between Immunofluorescence And Enzyme Immunoassay</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>
      detection of anti-ds DNA in patients with rheumatic diseases by two methodes :&#xD;
      immunofluorescence &amp; ELISA&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Autoimmune rheumatic diseases are autoimmune disorders presented with joint and muscles&#xD;
      manifestations. However, other organs may be involved at a varying degree in different&#xD;
      conditions. They are also called connective tissue diseases (CTDs) or collagen diseases. They&#xD;
      include systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), Sjiogren's syndrome&#xD;
      (SjS), systemic sclerosis, polymyositis and dermatomyositis and mixed connective tissue&#xD;
      disease (Peakman and Vergani, 2009).&#xD;
&#xD;
      Autoimmune rheumatic diseases are characterized by presence of antinuclear antibodies (ANA).&#xD;
      These antibodies are involved in the disease pathogenesis, and their presence in patients'&#xD;
      sera constitutes one of the criteria used (together with the clinical manifestations) for&#xD;
      disease diagnosis (Stevens, 2010). ANA include autoantibodies to extractable nuclear antigens&#xD;
      and autoantibodies to histones and deoxyribonucleic acid (DNA).&#xD;
&#xD;
      Anti-DNA antibodies include those against single and double stranded DNA (ssDNA and dsDNA,&#xD;
      respectively). Anti-dsDNA antibodies are recognized as diagnostic markers of SLE and as&#xD;
      indicators of SLE disease activity, especially in lupus nephritis (Zigon et al.,&#xD;
      2011).However, high anti-dsDNA levels are found only in 50-70% of SLE patients. So, negative&#xD;
      anti-dsDNA test does not exclude SLE Also, anti-dsDNA antibodies can be detected in other&#xD;
      autoimmune diseases such as RA and SjS, as well as in healthy blood donors (Zigon et al.,&#xD;
      2011).The significance of anti-dsDNA in SLE diagnosis and in monitoring SLE disease activity&#xD;
      has led to an increase in this test laboratory requests as well as in the number of&#xD;
      commercially available kits (Chiaro et al., 2011).&#xD;
&#xD;
      The kits that are used in detection and quantitation of anti-dsDNA antibodies include:&#xD;
&#xD;
        1. Radioimmunoassay methods developed according to Farr technique (FARR-RIA) (Wold et al.,&#xD;
           1968). However, due to the use of radioactive element in the Farr assay, it is not&#xD;
           widely used in the routine diagnostic laboratory work (Mahler and Fritzler, 2007).&#xD;
&#xD;
        2. Crithidia luciliae immunofluorescence test (CLIFT) developed by Aarden et al (1975)&#xD;
           detects anti-dsDNA by indirect immunofluorescence using the hemoflagellate Crithidia&#xD;
           luciliae which contains kinetoplast that contains a high concentration of native (dsDNA)&#xD;
           DNA (Zigon et al., 2011). However, reading and interpretation of the immunoflourescence&#xD;
           is subjective and depends on the experience and training of the laboratory personnel&#xD;
           which could affects the test results (Chiaro et al., 2011).&#xD;
&#xD;
        3. Enzyme-linked immunosorbant assay (ELISA) is simple to perform, does not require highly&#xD;
           trained operators and can be automated. Therefore, it is becoming the most widely used&#xD;
           method (Kumar et al., 2009).With the increasing number of anti-dsDNA ELISA assays, the&#xD;
           potential for variability in the diagnostic accuracies is enormous as different&#xD;
           antigens, assay principles and cutoff determinations are employed (Chiaro et al., 2011).&#xD;
           Anti- dsDNA ELISAs may give false-positive results due to binding of immune complexes to&#xD;
           the pre-coat intermediates (Zigon et al., 2011).&#xD;
&#xD;
      In the Laboratory of Clinical Immunology, Assiut University Hospital, we shifted from manual&#xD;
      ELISA kits to automated ELISA platform (Alegria system, Orgentec Diagnostika, Germany) and&#xD;
      recently CLIFT was introduced in the laboratory.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2018</start_date>
  <completion_date type="Anticipated">October 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>The study will include patients with suspected diagnosis of autoimmune rheumatic diseases referred to the Laboratory of Clinical Immunology, Clinical Pathology Department, Assiut University Hospital for anti-dsDNA test. Patients will be recruited into the study within period of one year.&#xD;
Also, apparently healthy subjects (at least 25 subjects; according to international method verification guidelines) will be included as a control group.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison Between Immunofluorescence and Enzyme Immunoassay</measure>
    <time_frame>one year</time_frame>
    <description>Verfication of the anti-dsDNA examination methods used in the Laboratory of Clinical Immunology, Assiut University Hospital.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Detection of Anti-Double Stranded Deoxyribonucleic Acid Antibodies in Autoimmune Rheumatic Diseases</measure>
    <time_frame>one year</time_frame>
    <description>Verfication of the anti-dsDNA examination</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Antiphospholipid Syndrome</condition>
  <arm_group>
    <arm_group_label>anti-ds DNA</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>anti-ds DNA</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>anti-ds DNA</intervention_name>
    <description>venous blood samples</description>
    <arm_group_label>anti-ds DNA</arm_group_label>
    <other_name>venous blood samples</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The study will include patients with suspected diagnosis of autoimmune rheumatic&#xD;
             diseases referred to the Laboratory of Clinical Immunology, Clinical Pathology&#xD;
             Department, Assiut University Hospital for anti-dsDNA test. Patients will be recruited&#xD;
             into the study within period of one year.&#xD;
&#xD;
        Also, apparently healthy subjects (at least 25 subjects; according to international method&#xD;
        verification guidelines) will be included as a control group&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects refused to be included in the study. Patients without a definite diagnosis of&#xD;
             autoimmune rheumatic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Bai Y, Tong Y, Liu Y, Hu H. Self-dsDNA in the pathogenesis of systemic lupus erythematosus. Clin Exp Immunol. 2018 Jan;191(1):1-10. doi: 10.1111/cei.13041. Epub 2017 Sep 15.</citation>
    <PMID>28836661</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>October 2, 2017</last_update_submitted>
  <last_update_submitted_qc>October 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>SONagi</investigator_full_name>
    <investigator_title>Detection of Anti-Double Stranded Deoxyribonucleic Acid Antibodies in Autoimmune Rheumatic Diseases</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antiphospholipid Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03303508
org study id: CLIFT & ELISA
nct id: NCT03303508
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
detection of anti-ds DNA in patients with rheumatic diseases by two methodes :
      immunofluorescence & ELISA
Autoimmune rheumatic diseases are autoimmune disorders presented with joint and muscles
      manifestations. However, other organs may be involved at a varying degree in different
      conditions. They are also called connective tissue diseases (CTDs) or collagen diseases. They
      include systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), Sjiogren's syndrome
      (SjS), systemic sclerosis, polymyositis and dermatomyositis and mixed connective tissue
      disease (Peakman and Vergani, 2009).

      Autoimmune rheumatic diseases are characterized by presence of antinuclear antibodies (ANA).
      These antibodies are involved in the disease pathogenesis, and their presence in patients'
      sera constitutes one of the criteria used (together with the clinical manifestations) for
      disease diagnosis (Stevens, 2010). ANA include autoantibodies to extractable nuclear antigens
      and autoantibodies to histones and deoxyribonucleic acid (DNA).

      Anti-DNA antibodies include those against single and double stranded DNA (ssDNA and dsDNA,
      respectively). Anti-dsDNA antibodies are recognized as diagnostic markers of SLE and as
      indicators of SLE disease activity, especially in lupus nephritis (Zigon et al.,
      2011).However, high anti-dsDNA levels are found only in 50-70% of SLE patients. So, negative
      anti-dsDNA test does not exclude SLE Also, anti-dsDNA antibodies can be detected in other
      autoimmune diseases such as RA and SjS, as well as in healthy blood donors (Zigon et al.,
      2011).The significance of anti-dsDNA in SLE diagnosis and in monitoring SLE disease activity
      has led to an increase in this test laboratory requests as well as in the number of
      commercially available kits (Chiaro et al., 2011).

      The kits that are used in detection and quantitation of anti-dsDNA antibodies include:

        1. Radioimmunoassay methods developed according to Farr technique (FARR-RIA) (Wold et al.,
           1968). However, due to the use of radioactive element in the Farr assay, it is not
           widely used in the routine diagnostic laboratory work (Mahler and Fritzler, 2007).

        2. Crithidia luciliae immunofluorescence test (CLIFT) developed by Aarden et al (1975)
           detects anti-dsDNA by indirect immunofluorescence using the hemoflagellate Crithidia
           luciliae which contains kinetoplast that contains a high concentration of native (dsDNA)
           DNA (Zigon et al., 2011). However, reading and interpretation of the immunoflourescence
           is subjective and depends on the experience and training of the laboratory personnel
           which could affects the test results (Chiaro et al., 2011).

        3. Enzyme-linked immunosorbant assay (ELISA) is simple to perform, does not require highly
           trained operators and can be automated. Therefore, it is becoming the most widely used
           method (Kumar et al., 2009).With the increasing number of anti-dsDNA ELISA assays, the
           potential for variability in the diagnostic accuracies is enormous as different
           antigens, assay principles and cutoff determinations are employed (Chiaro et al., 2011).
           Anti- dsDNA ELISAs may give false-positive results due to binding of immune complexes to
           the pre-coat intermediates (Zigon et al., 2011).

      In the Laboratory of Clinical Immunology, Assiut University Hospital, we shifted from manual
      ELISA kits to automated ELISA platform (Alegria system, Orgentec Diagnostika, Germany) and
      recently CLIFT was introduced in the laboratory.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The study will include patients with suspected diagnosis of autoimmune rheumatic diseases referred to the Laboratory of Clinical Immunology, Clinical Pathology Department, Assiut University Hospital for anti-dsDNA test. Patients will be recruited into the study within period of one year.
Also, apparently healthy subjects (at least 25 subjects; according to international method verification guidelines) will be included as a control group.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Comparison Between Immunofluorescence and Enzyme Immunoassay
time frame: one year
description: Verfication of the anti-dsDNA examination methods used in the Laboratory of Clinical Immunology, Assiut University Hospital.
measure: Detection of Anti-Double Stranded Deoxyribonucleic Acid Antibodies in Autoimmune Rheumatic Diseases
time frame: one year
description: Verfication of the anti-dsDNA examination
arm group label: anti-ds DNA
arm group type: Other
description: anti-ds DNA
intervention type: Diagnostic Test
intervention name: anti-ds DNA
description: venous blood samples
arm group label: anti-ds DNA
other name: venous blood samples
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
citation: Bai Y, Tong Y, Liu Y, Hu H. Self-dsDNA in the pathogenesis of systemic lupus erythematosus. Clin Exp Immunol. 2018 Jan;191(1):1-10. doi: 10.1111/cei.13041. Epub 2017 Sep 15.
PMID: 28836661
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: SONagi
investigator title: Detection of Anti-Double Stranded Deoxyribonucleic Acid Antibodies in Autoimmune Rheumatic Diseases
mesh term: Antiphospholipid Syndrome