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/NCT05992727</url>
    </required_header>
    <id_info>
      <org_study_id>Galectin -3 and pemphigus</org_study_id>
      <nct_id>NCT05992727</nct_id>
    </id_info>
    <brief_title>Evaluation of Galectin-3 in Serum and Saliva of Pemphigus Patients</brief_title>
    <official_title>Evaluation of Galectin 3 Level in Serum and Saliva of Pemphigus Patients and Its Correlation With Disease Severity and Systemic Comorbidities</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</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>
        Assessment of the expression of galectin-3 in serum and saliva of pemphigus patients and&#xD;
        compare it with age and sex matched controls. We want to detect whether a correlation exists&#xD;
        between galectin-3 level in serum, as well as saliva and disease activity score by Autoimmune&#xD;
        Bullous Skin Disorder Intensity Score (ABSIS).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pemphigus is a potentially life- threatening immune mediated bullous disease that affects the&#xD;
        skin and mucous membranes with a significant impact on quality of life (1). It is due to&#xD;
        production of autoantibodies against desmogleins (adhesion molecules of the epidermis)&#xD;
        leading to disruption of junctions between keratinocytes and subsequently acantholysis (2).&#xD;
  &#xD;
        Pemphigus diseases are classified based on the clinical, histopathological features, as well&#xD;
        as on the specific antigens against which the autoantibodies are produced. The main forms are&#xD;
        pemphigus vulgaris (PV) and pemphigus folia¬ceus (PF), but other non-classical forms of&#xD;
        pemphigus have also been described as paraneoplastic pemphigus, pemphigus herpetiformis, and&#xD;
        IgA pemphigus (3). PV is the main clinical form of pemphigus, accounting for approximately&#xD;
        70% of cases; it is also considered the most severe form of the disease (4).&#xD;
  &#xD;
        IgG is the main immunoglobulin seen along the dermal-epidermal junction in pemphigus&#xD;
        patients, in addition most patients generate IgE autoantibody response. Soluble CD23 and&#xD;
        galectin-3 are the two main elements of the IgE (5).&#xD;
  &#xD;
        Galectin-3(Gal-3) is a beta galactoside-binding lectins that is essential in the cell-to-cell&#xD;
        or matrix adhesion, as well as plays an important role in cell growth, differentiation,&#xD;
        macrophage activation, antimicrobial activity, angiogenesis, and apoptosis. It broadly exists&#xD;
        in the nucleus and cytoplasm of various cell types or may be found extracellularly on the&#xD;
        cell surface (6) .Gal-3 is readily secreted to the cell surface and into biological fluids as&#xD;
        serum, urine, tears and saliva from injured and inflammatory cells. So, it can be used as a&#xD;
        sensitive diagnostic or prognostic biomarker for various pathological conditions (7).&#xD;
  &#xD;
        Gal-3 has been used as a novel biomarker in the early detection of myocardial dysfunction and&#xD;
        heart failure. Many cardiac biomarkers which reflect cardiac inflammation and fibrosis may&#xD;
        also contribute to the progression of kidney disease (8, 9) A previous study reported a&#xD;
        significant decrease in galectin-3 cytoplasmic and nuclear expression around blisters&#xD;
        compared with adjacent unaffected skin in PV, which may play a role in extension of&#xD;
        acantholysis (5). To the best of our knowledge, no previous studies assessed the role of&#xD;
        Gal-3 in serum or saliva of pemphigus patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 8, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Assessment of Galectin 3</measure>
      <time_frame>1 year</time_frame>
      <description>Three millimeters of blood will be withdrawn aseptically from all patients and controls from the antecubital vein using disposable plastic syringe. The sera will be separated and stored at -20 C. Saliva will be collected from patients and controls after asking them to refrain from eating and drinking (except for water) for 2 hours before collection. Then, they will be asked to rinse their mouth with water, tilt their heads down, pool saliva in the mouth for 1 minute, drool into a sterile falcon tube. Saliva will be separated and stored also at-20 C. Human Gal-3 ELISA kit will be used for quantitative measurement of serum and saliva Gal-3 levels. The assay will be performed according to the manufacturer's instructions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Develop a novel biomarker in serum and saliva of pemphigus patients and to detect its correlation with disease activity, as well as systemic comorbidities.</measure>
      <time_frame>1year</time_frame>
      <description>All patients will be subjected to complete history taking, meticulous general, dermatological examination and routine investigations. Echocardiography, kidney function tests and urine analysis will be conducted for all the participants. Disease severity will be assessed by ABSIS score with a maximum score of 206. It uses the rule of 9s to assess the percentage of involvement of blisters and erosions on the skin combined with a weighting factor for the stage of the blistering and erosions. Oral involvement is based on 2 scores comprising the extent (presence of lesions) and severity (discomfort during eating and drinking)</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Galectin-3 and Pemphigus</condition>
    <arm_group>
      <arm_group_label>Group 1( cases)</arm_group_label>
      <description>Galectin 3 will be measured in 30 Patients who are with active stage of pemphigus either newly diagnosed or in a relapse. The diagnosis of each patient is based on clinical examination and histopathological examination.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2( controls)</arm_group_label>
      <description>Galectin 3 will be measured in30 age and sex matched healthy controls</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Galectin 3 measurement in serum and saliva by ELIZA</intervention_name>
      <description>Galectin 3 measurement in serum and saliva by ELISA in the two groups</description>
      <arm_group_label>Group 1( cases)</arm_group_label>
      <arm_group_label>Group 2( controls)</arm_group_label>
      <other_name>complete blood count,renal function tests, random blood sugar,urine analysis and echocardiography</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Pemphigus patients in active stage either newly diagnosed or in a relapse. The diagnosis of&#xD;
          each patient is based on clinical examination , histopathological examination and direct&#xD;
          immunofluorescence.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients with active stage of pemphigus.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients who were on topical ttt, systemic corticosteroids or other immunosuppressive&#xD;
               drugs in the last one month.&#xD;
  &#xD;
            2. Patients with disease attack duration more than 1 week.&#xD;
  &#xD;
            3. Patients with any other concomitant dermatological or chronic systemic diseases.&#xD;
  &#xD;
               -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Eman Fathy, MD</last_name>
      <phone>+201002258614</phone>
      <email>emanfathy639@yahoo.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Heba Hasan, MD</last_name>
      <phone>+201002866919</phone>
      <email>hebahasan16888@yahoo.com</email>
    </overall_contact_backup>
    <results_reference>
      <citation>Aghighi M, Pukhalskaya T, Smoller BR. Immunohistochemical Expression of Galectin-3 in Pemphigus Vulgaris. Am J Dermatopathol. 2021 Dec 1;43(12):e165-e168. doi: 10.1097/DAD.0000000000001939.</citation>
      <PMID>33767069</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Eman Fathy Ahmed</investigator_full_name>
      <investigator_title>Doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pemphigus</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/NCT05992727
  org study id: Galectin -3 and pemphigus
  nct id: NCT05992727
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Assessment of the expression of galectin-3 in serum and saliva of pemphigus patients and
        compare it with age and sex matched controls. We want to detect whether a correlation exists
        between galectin-3 level in serum, as well as saliva and disease activity score by Autoimmune
        Bullous Skin Disorder Intensity Score (ABSIS).
  Pemphigus is a potentially life- threatening immune mediated bullous disease that affects the
        skin and mucous membranes with a significant impact on quality of life (1). It is due to
        production of autoantibodies against desmogleins (adhesion molecules of the epidermis)
        leading to disruption of junctions between keratinocytes and subsequently acantholysis (2).
  
        Pemphigus diseases are classified based on the clinical, histopathological features, as well
        as on the specific antigens against which the autoantibodies are produced. The main forms are
        pemphigus vulgaris (PV) and pemphigus folia¬ceus (PF), but other non-classical forms of
        pemphigus have also been described as paraneoplastic pemphigus, pemphigus herpetiformis, and
        IgA pemphigus (3). PV is the main clinical form of pemphigus, accounting for approximately
        70% of cases; it is also considered the most severe form of the disease (4).
  
        IgG is the main immunoglobulin seen along the dermal-epidermal junction in pemphigus
        patients, in addition most patients generate IgE autoantibody response. Soluble CD23 and
        galectin-3 are the two main elements of the IgE (5).
  
        Galectin-3(Gal-3) is a beta galactoside-binding lectins that is essential in the cell-to-cell
        or matrix adhesion, as well as plays an important role in cell growth, differentiation,
        macrophage activation, antimicrobial activity, angiogenesis, and apoptosis. It broadly exists
        in the nucleus and cytoplasm of various cell types or may be found extracellularly on the
        cell surface (6) .Gal-3 is readily secreted to the cell surface and into biological fluids as
        serum, urine, tears and saliva from injured and inflammatory cells. So, it can be used as a
        sensitive diagnostic or prognostic biomarker for various pathological conditions (7).
  
        Gal-3 has been used as a novel biomarker in the early detection of myocardial dysfunction and
        heart failure. Many cardiac biomarkers which reflect cardiac inflammation and fibrosis may
        also contribute to the progression of kidney disease (8, 9) A previous study reported a
        significant decrease in galectin-3 cytoplasmic and nuclear expression around blisters
        compared with adjacent unaffected skin in PV, which may play a role in extension of
        acantholysis (5). To the best of our knowledge, no previous studies assessed the role of
        Gal-3 in serum or saliva of pemphigus patients.
  observational model: Case-Control
  time perspective: Prospective
  measure: Assessment of Galectin 3
  time frame: 1 year
  description: Three millimeters of blood will be withdrawn aseptically from all patients and controls from the antecubital vein using disposable plastic syringe. The sera will be separated and stored at -20 C. Saliva will be collected from patients and controls after asking them to refrain from eating and drinking (except for water) for 2 hours before collection. Then, they will be asked to rinse their mouth with water, tilt their heads down, pool saliva in the mouth for 1 minute, drool into a sterile falcon tube. Saliva will be separated and stored also at-20 C. Human Gal-3 ELISA kit will be used for quantitative measurement of serum and saliva Gal-3 levels. The assay will be performed according to the manufacturer's instructions.
  measure: Develop a novel biomarker in serum and saliva of pemphigus patients and to detect its correlation with disease activity, as well as systemic comorbidities.
  time frame: 1year
  description: All patients will be subjected to complete history taking, meticulous general, dermatological examination and routine investigations. Echocardiography, kidney function tests and urine analysis will be conducted for all the participants. Disease severity will be assessed by ABSIS score with a maximum score of 206. It uses the rule of 9s to assess the percentage of involvement of blisters and erosions on the skin combined with a weighting factor for the stage of the blistering and erosions. Oral involvement is based on 2 scores comprising the extent (presence of lesions) and severity (discomfort during eating and drinking)
  arm group label: Group 1( cases)
  description: Galectin 3 will be measured in 30 Patients who are with active stage of pemphigus either newly diagnosed or in a relapse. The diagnosis of each patient is based on clinical examination and histopathological examination.
  arm group label: Group 2( controls)
  description: Galectin 3 will be measured in30 age and sex matched healthy controls
  intervention type: Diagnostic Test
  intervention name: Galectin 3 measurement in serum and saliva by ELIZA
  description: Galectin 3 measurement in serum and saliva by ELISA in the two groups
  arm group label: Group 1( cases)
  arm group label: Group 2( controls)
  other name: complete blood count,renal function tests, random blood sugar,urine analysis and echocardiography
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Eman Fathy, MD
  phone: +201002258614
  email: emanfathy639@yahoo.com
  last name: Heba Hasan, MD
  phone: +201002866919
  email: hebahasan16888@yahoo.com
  citation: Aghighi M, Pukhalskaya T, Smoller BR. Immunohistochemical Expression of Galectin-3 in Pemphigus Vulgaris. Am J Dermatopathol. 2021 Dec 1;43(12):e165-e168. doi: 10.1097/DAD.0000000000001939.
  PMID: 33767069
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Eman Fathy Ahmed
  investigator title: Doctor
  mesh term: Pemphigus