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/NCT06005389</url>
    </required_header>
    <id_info>
      <org_study_id>Galectin-3 and HPV infection</org_study_id>
      <nct_id>NCT06005389</nct_id>
    </id_info>
    <brief_title>Serum Galectin-3 as a Marker of Human Papillomavirus Infection</brief_title>
    <official_title>Serum Galectin-3: A Potential Marker of Human Papillomavirus Infection Before and After Treatment of Cutaneous Warts</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>
        This study aimed to assess the serum Galectin-3 levels in patients with warts both before and&#xD;
        after cryotherapy and to investigate its potential contribution to the pathogenesis of human&#xD;
        papillomavirus infection.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Galectin-3 regulates many functions at the cellular level such as cell attachment,&#xD;
        proliferation, and apoptosis. Numerous viral illnesses, including human papillomavirus&#xD;
        infection, were reported to have elevated serum levels of Galectin-3. .&#xD;
  &#xD;
        Methods: Fifty patients suffering from warts, and fifty healthy controls were included in&#xD;
        this study. Enzyme-linked immunosorbent assay was used to measure serum levels of Galectin-3&#xD;
        both before and 2 weeks after the last cryotherapy session.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 1, 2021</start_date>
    <completion_date type="Actual">February 1, 2023</completion_date>
    <primary_completion_date type="Actual">December 1, 2022</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>Serum Galectin-3 levels assessment in patients with cutaneous warts.</measure>
      <time_frame>1 year</time_frame>
      <description>3 ml of venous blood from each patient and control was drawn under strict aseptic conditions employing a single-use plastic syringe. Once the blood had been collected, it was put in a simple tube without an anticoagulant and left there for 30 minutes at room temperature until coagulation had taken place. The tubes were then centrifuged at 1000 rpm for 20 minutes. For further examination, an aliquot of the serum was taken and stored at 20 degrees Celsius. Human Galectin-3 enzyme-linked immunosorbent assay (ELISA) kits with the catalogue number (ELK2790) from ELK Biotechnology CO., LTD, Wuhan, China, were used to quantify serum Gal-3 in accordance with the manufacturer's instructions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>look at Galectin-3 serum level conceivable contribution to the aetiology of HPV infection, and determine how cryotherapy affected serum Galectin-3 levels.</measure>
      <time_frame>1 year</time_frame>
      <description>All patients had a thorough medical history taken, which included information on their age, sex, occupation, the number of warts, their location, size, and past treatments, as well as any previous systemic or skin conditions or drug use. A thorough examination was performed on each patient to determine the location, kind, size, and number of warts as well as to rule out any systemic or other skin conditions.&#xD;
  Before and two weeks after the last cryotherapy treatment session, serum Galectin-3 was assessed. Every patient had a cryotherapy session every 2 weeks until complete clearance for a maximum of six sessions and follow-up was done at 3 months after treatment completion to detect any recurrence. Each wart was frozen using the spray technique by CRY-AC Liquid Nitrogen Dispenser Brymill, USA for 10 to 30 seconds until an ice ball halo of 1 to 2 mm diameter encircled the intended area.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">100</enrollment>
    <condition>Human Papillomavirus Infection</condition>
    <arm_group>
      <arm_group_label>50 patients with common or planter cutaneous warts</arm_group_label>
      <description>Every patient had a cryotherapy session every 2 weeks until complete clearance for a maximum of six sessions and follow-up was done at 3 months after treatment completion to detect any recurrence. The therapeutic efficacy was evaluated by a decrease in the size (measured by a ruler) and the number of warts with photographic documentation at (the baseline, each visit, 2 weeks after the final session, and the 3 months follow-up period). The response of the treated wart was considered: complete; if there was a disappearance of the wart and appearance of normal skin markings, partial; if the warts had regressed in size or decreased in number and no response; if no decrease in wart size or number.&#xD;
  From each patient 3 ml venous blood was withdrawn under complete aseptic conditions before treatment and 2 weeks after the last treatment session by a disposable plastic syringe. Serum Gal-3 was measured using human Galectin-3 enzyme-linked immunosorbent assay (ELISA) kits.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>50 healthy age-and sex-matched control subjects.</arm_group_label>
      <description>From each control subject, 3 ml venous blood was withdrawn under complete aseptic conditions before treatment and 2 weeks after the last treatment session by a disposable plastic syringe. Serum Gal-3 was measured using human Galectin-3 enzyme-linked immunosorbent assay (ELISA) kits.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>cryotherapy</intervention_name>
      <description>Every patient had a cryotherapy session every 2 weeks until complete clearance for a maximum of six sessions and follow-up was done at 3 months after treatment completion to detect any recurrence. Each wart was frozen using the spray technique by CRY-AC Liquid Nitrogen Dispenser Brymill, USA for 10 to 30 seconds until a 1- to 2-mm ice ball halo was formed surrounding the targeted area.</description>
      <arm_group_label>50 patients with common or planter cutaneous warts</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>serum Galectin-3 assay</intervention_name>
      <description>From each patient and control, 3 ml venous blood was withdrawn under complete aseptic conditions before treatment and 2 weeks after the last treatment session by a disposable plastic syringe; the collected blood was placed on a plain tube without anticoagulant for 30 min at room temperature till coagulation occurs; after this, centrifugation of tubes was done for 20 min at 1000 rpm. The serum was separated into an aliquot and placed at -20 degrees Celsius for further analysis. Serum Gal-3 was measured using human Galectin-3 enzyme-linked immunosorbent assay (ELISA) kits supplied by ELK Biotechnology CO., LTD, Wuhan, China, catalog number (ELK2790) based on the Sandwich-ELISA technique as per the manufacturer's instructions.</description>
      <arm_group_label>50 healthy age-and sex-matched control subjects.</arm_group_label>
      <arm_group_label>50 patients with common or planter cutaneous warts</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          This case-control study was performed on 50 patients with any type of cutaneous warts&#xD;
          except for genital warts and 50 apparently healthy age-and sex-matched control subjects&#xD;
          without a history of warts attending the Outpatient Clinic of Dermatology, Venereology and&#xD;
          Andrology Department of Assiut University Hospitals.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            1. Patients with non-genital warts.&#xD;
  &#xD;
            2. Age of patients: from 18 to 60 years.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            1. Patients with genital and mucosal warts.&#xD;
  &#xD;
            2. Pregnancy and breastfeeding.&#xD;
  &#xD;
            3. Patients who received any wart treatment during the last month before enrollment in&#xD;
               the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Assiut University</name>
        <address>
          <city>Assiut</city>
          <zip>71511</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Coppock JD, Mills AM, Stelow EB. Galectin-3 Expression in High-Risk HPV-Positive and Negative Head &amp; Neck Squamous Cell Carcinomas and Regional Lymph Node Metastases. Head Neck Pathol. 2021 Mar;15(1):163-168. doi: 10.1007/s12105-020-01195-3. Epub 2020 Jun 20.</citation>
      <PMID>32564273</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Heba Hasan Sayed</investigator_full_name>
      <investigator_title>lecturer</investigator_title>
    </responsible_party>
    <keyword>Galectin-3</keyword>
    <keyword>Human papillomavirus</keyword>
    <keyword>Warts</keyword>
    <keyword>Cryotherapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infections</mesh_term>
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Papillomavirus Infections</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/NCT06005389
  org study id: Galectin-3 and HPV infection
  nct id: NCT06005389
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study aimed to assess the serum Galectin-3 levels in patients with warts both before and
        after cryotherapy and to investigate its potential contribution to the pathogenesis of human
        papillomavirus infection.
  Galectin-3 regulates many functions at the cellular level such as cell attachment,
        proliferation, and apoptosis. Numerous viral illnesses, including human papillomavirus
        infection, were reported to have elevated serum levels of Galectin-3. .
  
        Methods: Fifty patients suffering from warts, and fifty healthy controls were included in
        this study. Enzyme-linked immunosorbent assay was used to measure serum levels of Galectin-3
        both before and 2 weeks after the last cryotherapy session.
  observational model: Case-Control
  time perspective: Prospective
  measure: Serum Galectin-3 levels assessment in patients with cutaneous warts.
  time frame: 1 year
  description: 3 ml of venous blood from each patient and control was drawn under strict aseptic conditions employing a single-use plastic syringe. Once the blood had been collected, it was put in a simple tube without an anticoagulant and left there for 30 minutes at room temperature until coagulation had taken place. The tubes were then centrifuged at 1000 rpm for 20 minutes. For further examination, an aliquot of the serum was taken and stored at 20 degrees Celsius. Human Galectin-3 enzyme-linked immunosorbent assay (ELISA) kits with the catalogue number (ELK2790) from ELK Biotechnology CO., LTD, Wuhan, China, were used to quantify serum Gal-3 in accordance with the manufacturer's instructions.
  measure: look at Galectin-3 serum level conceivable contribution to the aetiology of HPV infection, and determine how cryotherapy affected serum Galectin-3 levels.
  time frame: 1 year
  description: All patients had a thorough medical history taken, which included information on their age, sex, occupation, the number of warts, their location, size, and past treatments, as well as any previous systemic or skin conditions or drug use. A thorough examination was performed on each patient to determine the location, kind, size, and number of warts as well as to rule out any systemic or other skin conditions.
  Before and two weeks after the last cryotherapy treatment session, serum Galectin-3 was assessed. Every patient had a cryotherapy session every 2 weeks until complete clearance for a maximum of six sessions and follow-up was done at 3 months after treatment completion to detect any recurrence. Each wart was frozen using the spray technique by CRY-AC Liquid Nitrogen Dispenser Brymill, USA for 10 to 30 seconds until an ice ball halo of 1 to 2 mm diameter encircled the intended area.
  arm group label: 50 patients with common or planter cutaneous warts
  description: Every patient had a cryotherapy session every 2 weeks until complete clearance for a maximum of six sessions and follow-up was done at 3 months after treatment completion to detect any recurrence. The therapeutic efficacy was evaluated by a decrease in the size (measured by a ruler) and the number of warts with photographic documentation at (the baseline, each visit, 2 weeks after the final session, and the 3 months follow-up period). The response of the treated wart was considered: complete; if there was a disappearance of the wart and appearance of normal skin markings, partial; if the warts had regressed in size or decreased in number and no response; if no decrease in wart size or number.
  From each patient 3 ml venous blood was withdrawn under complete aseptic conditions before treatment and 2 weeks after the last treatment session by a disposable plastic syringe. Serum Gal-3 was measured using human Galectin-3 enzyme-linked immunosorbent assay (ELISA) kits.
  arm group label: 50 healthy age-and sex-matched control subjects.
  description: From each control subject, 3 ml venous blood was withdrawn under complete aseptic conditions before treatment and 2 weeks after the last treatment session by a disposable plastic syringe. Serum Gal-3 was measured using human Galectin-3 enzyme-linked immunosorbent assay (ELISA) kits.
  intervention type: Procedure
  intervention name: cryotherapy
  description: Every patient had a cryotherapy session every 2 weeks until complete clearance for a maximum of six sessions and follow-up was done at 3 months after treatment completion to detect any recurrence. Each wart was frozen using the spray technique by CRY-AC Liquid Nitrogen Dispenser Brymill, USA for 10 to 30 seconds until a 1- to 2-mm ice ball halo was formed surrounding the targeted area.
  arm group label: 50 patients with common or planter cutaneous warts
  intervention type: Diagnostic Test
  intervention name: serum Galectin-3 assay
  description: From each patient and control, 3 ml venous blood was withdrawn under complete aseptic conditions before treatment and 2 weeks after the last treatment session by a disposable plastic syringe; the collected blood was placed on a plain tube without anticoagulant for 30 min at room temperature till coagulation occurs; after this, centrifugation of tubes was done for 20 min at 1000 rpm. The serum was separated into an aliquot and placed at -20 degrees Celsius for further analysis. Serum Gal-3 was measured using human Galectin-3 enzyme-linked immunosorbent assay (ELISA) kits supplied by ELK Biotechnology CO., LTD, Wuhan, China, catalog number (ELK2790) based on the Sandwich-ELISA technique as per the manufacturer's instructions.
  arm group label: 50 healthy age-and sex-matched control subjects.
  arm group label: 50 patients with common or planter cutaneous warts
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Egypt
  citation: Coppock JD, Mills AM, Stelow EB. Galectin-3 Expression in High-Risk HPV-Positive and Negative Head & Neck Squamous Cell Carcinomas and Regional Lymph Node Metastases. Head Neck Pathol. 2021 Mar;15(1):163-168. doi: 10.1007/s12105-020-01195-3. Epub 2020 Jun 20.
  PMID: 32564273
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Heba Hasan Sayed
  investigator title: lecturer
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Papillomavirus Infections