<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/NCT03830710</url>
  </required_header>
  <id_info>
    <org_study_id>1234</org_study_id>
    <nct_id>NCT03830710</nct_id>
  </id_info>
  <brief_title>8-Hydroxy-2-Deoxyguanosine ,Total Antioxidant Capacity in Oral Premalignant and Malignant Lesions</brief_title>
  <official_title>Detection of Salivary 8-Hydroxy-2-Deoxyguanosine and Total Antioxidant Capacity in Patients With Oral Premalignant and Malignant Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fayoum University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fayoum University</source>
  <oversight_info>
    <has_dmc>Yes</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: Investigating the level of salivary 8-hydroxy-2-deoxyguanosine (8-OHdG) and total&#xD;
      antioxidant capacity (TAC) in oral premalignant and malignant lesions in order to determine&#xD;
      their diagnostic value for the malignant patients. Design: 120 subjects diagnosed with oral&#xD;
      leukoplakia, oral lichen planus (OLP) and oral squamous cell carcinoma (OSCC) along with&#xD;
      healthy control subjects were included. Salivary samples from all participants were&#xD;
      collected. 8-OHdG was measured by ELISA technique and the TAC level was assessed by a&#xD;
      photometric test system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Detection of molecular markers in saliva is superior to their detection in serum and other&#xD;
      body fluids due to the fact of being an easy non-invasive tool requiring no training for its&#xD;
      collection. Consequently, the aim of our work was to investigate salivary 8-OHdG and TAC in&#xD;
      premalignant and malignant patients compared to normal subjects and to determine their&#xD;
      diagnostic value for the malignant patients.&#xD;
&#xD;
      Methodology:&#xD;
&#xD;
      Study population:&#xD;
&#xD;
      A total of 120 subjects were enrolled in the present study. The clinically tested and&#xD;
      confirmed subjects included Group A: 30 patients diagnosed with oral leukoplakia Group B: 30&#xD;
      patients suffering from oral lichen planus Group C: 30 patients having oral squamous cell&#xD;
      carcinoma with the tongue being the most commonly affected site Group D: 30 age and gender&#xD;
      matched individuals having no oral mucosal lesions acting as a control group.&#xD;
&#xD;
      Comprehensive oral diagnosis was done for all participating individuals. Biopsy specimens&#xD;
      were obtained from various lesions where a surgical double wedge incisional biopsy was&#xD;
      carried out to a depth of about 2mm. Specimens were sent for histopathological examination to&#xD;
      confirm the clinical diagnosis.&#xD;
&#xD;
      Salivary sample collection: Collection of whole unstimulated saliva from all participants was&#xD;
      performed using standard techniques.Subjects refrained from eating, drinking, chewing gum&#xD;
      etc., for at least ½ h before the evaluation.Samples were collected by asking individuals to&#xD;
      swallow first, tilt their head forward and expectorate all saliva in a tube for 5 minutes&#xD;
      without swallowing. After collection, all samples were immediately stored at -20ºC until&#xD;
      assayed.&#xD;
&#xD;
      Detection of salivary 8-OHdG: Saliva was centrifuged for 5 minutes at 5000 x g. The&#xD;
      supernatant was removed for determination of 8- hydroxy-2'-deoxyguanosine using an ELISA kit&#xD;
      provided by BioVision, USA (Catalog # K4160-100). 8-hydroxy-2'-deoxyguanosine is an oxidized&#xD;
      derivative of deoxyguanosine and is one of the major products of DNA oxidation.&#xD;
&#xD;
      Determination of salivary total antioxidative status/capacity (TAS/TAC) was done using ImAnOx&#xD;
      (TAS/TAC) Kit provided by Immun Diagnostik, Germany. It is a photometric test system used for&#xD;
      the determination of the total antioxidative status/capacity in EDTA-plasma, serum and other&#xD;
      biological samples.&#xD;
&#xD;
      The determination of the antioxidative capacity was performed by the reaction of antioxidants&#xD;
      in the sample with a defined amount of exogenously provided hydrogen peroxide (H2O2). The&#xD;
      antioxidants in the sample eliminate a certain amount of the provided H2O2. The residual H2O2&#xD;
      was determined photometrically by an enzymatic reaction which involves the conversion of TMB&#xD;
      to a colored product. After addition of a stop solution, the samples were measured at 450 nm&#xD;
      in a microtiter plate reader. The quantification was performed by the delivered calibrator.&#xD;
      The difference between applied and measured peroxide concentration in a defined time period&#xD;
      is proportional to the reactivity of the antioxidants of the sample (antioxidative capacity).&#xD;
      Quantification was performed with the enclosed calibrator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">October 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Salivary 8-OHdG</measure>
    <time_frame>1 year</time_frame>
    <description>8-OHdG have a critical role in the pathogenesis of malignant lesions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>salivary TAC</measure>
    <time_frame>1 year</time_frame>
    <description>OSCC might be used as a tool to help diagnosis of OSCC but not to differentiate between various malignant grades</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>Premalignant Lesion</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <description>30 patients diagnosed with oral leukoplakia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <description>30 patients diagnosed with oral lichen planus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <description>30 patients having oral squamous cell carcinoma with the tongue being the most commonly affected site</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <description>30 age and gender matched individuals having no oral mucosal lesions acting as a control group</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The included subjects were all assessed medically according to the modified Cornell Medical&#xD;
        index (Kerr &amp; Millard, 1965).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All included individuals were not under any current medication, suffering from any systemic&#xD;
        condition or having any other oral mucosal disorder.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or lactating females&#xD;
&#xD;
          2. subjects having systemic disorder or taking medications;&#xD;
&#xD;
          3. subjects who suffer from any other mucosal lesions.&#xD;
&#xD;
          4. severe periodontal inflammation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>63 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sandy hassan shaaban</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>February 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>February 19, 2019</last_update_submitted>
  <last_update_submitted_qc>February 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fayoum University</investigator_affiliation>
    <investigator_full_name>Sandy Hassan</investigator_full_name>
    <investigator_title>lecturer</investigator_title>
  </responsible_party>
  <keyword>Squamous cell carcinoma</keyword>
  <keyword>8-hydroxy-2- deoxyguanosine</keyword>
  <keyword>Antioxidant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Precancerous Conditions</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT03830710/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03830710
org study id: 1234
nct id: NCT03830710
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objectives: Investigating the level of salivary 8-hydroxy-2-deoxyguanosine (8-OHdG) and total
      antioxidant capacity (TAC) in oral premalignant and malignant lesions in order to determine
      their diagnostic value for the malignant patients. Design: 120 subjects diagnosed with oral
      leukoplakia, oral lichen planus (OLP) and oral squamous cell carcinoma (OSCC) along with
      healthy control subjects were included. Salivary samples from all participants were
      collected. 8-OHdG was measured by ELISA technique and the TAC level was assessed by a
      photometric test system.
Detection of molecular markers in saliva is superior to their detection in serum and other
      body fluids due to the fact of being an easy non-invasive tool requiring no training for its
      collection. Consequently, the aim of our work was to investigate salivary 8-OHdG and TAC in
      premalignant and malignant patients compared to normal subjects and to determine their
      diagnostic value for the malignant patients.

      Methodology:

      Study population:

      A total of 120 subjects were enrolled in the present study. The clinically tested and
      confirmed subjects included Group A: 30 patients diagnosed with oral leukoplakia Group B: 30
      patients suffering from oral lichen planus Group C: 30 patients having oral squamous cell
      carcinoma with the tongue being the most commonly affected site Group D: 30 age and gender
      matched individuals having no oral mucosal lesions acting as a control group.

      Comprehensive oral diagnosis was done for all participating individuals. Biopsy specimens
      were obtained from various lesions where a surgical double wedge incisional biopsy was
      carried out to a depth of about 2mm. Specimens were sent for histopathological examination to
      confirm the clinical diagnosis.

      Salivary sample collection: Collection of whole unstimulated saliva from all participants was
      performed using standard techniques.Subjects refrained from eating, drinking, chewing gum
      etc., for at least ½ h before the evaluation.Samples were collected by asking individuals to
      swallow first, tilt their head forward and expectorate all saliva in a tube for 5 minutes
      without swallowing. After collection, all samples were immediately stored at -20ºC until
      assayed.

      Detection of salivary 8-OHdG: Saliva was centrifuged for 5 minutes at 5000 x g. The
      supernatant was removed for determination of 8- hydroxy-2'-deoxyguanosine using an ELISA kit
      provided by BioVision, USA (Catalog # K4160-100). 8-hydroxy-2'-deoxyguanosine is an oxidized
      derivative of deoxyguanosine and is one of the major products of DNA oxidation.

      Determination of salivary total antioxidative status/capacity (TAS/TAC) was done using ImAnOx
      (TAS/TAC) Kit provided by Immun Diagnostik, Germany. It is a photometric test system used for
      the determination of the total antioxidative status/capacity in EDTA-plasma, serum and other
      biological samples.

      The determination of the antioxidative capacity was performed by the reaction of antioxidants
      in the sample with a defined amount of exogenously provided hydrogen peroxide (H2O2). The
      antioxidants in the sample eliminate a certain amount of the provided H2O2. The residual H2O2
      was determined photometrically by an enzymatic reaction which involves the conversion of TMB
      to a colored product. After addition of a stop solution, the samples were measured at 450 nm
      in a microtiter plate reader. The quantification was performed by the delivered calibrator.
      The difference between applied and measured peroxide concentration in a defined time period
      is proportional to the reactivity of the antioxidants of the sample (antioxidative capacity).
      Quantification was performed with the enclosed calibrator.
observational model: Other
time perspective: Prospective
measure: Salivary 8-OHdG
time frame: 1 year
description: 8-OHdG have a critical role in the pathogenesis of malignant lesions
measure: salivary TAC
time frame: 1 year
description: OSCC might be used as a tool to help diagnosis of OSCC but not to differentiate between various malignant grades
arm group label: Group A
description: 30 patients diagnosed with oral leukoplakia
arm group label: Group B
description: 30 patients diagnosed with oral lichen planus
arm group label: Group C
description: 30 patients having oral squamous cell carcinoma with the tongue being the most commonly affected site
arm group label: Group D
description: 30 age and gender matched individuals having no oral mucosal lesions acting as a control group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 63 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Fayoum University
investigator full name: Sandy Hassan
investigator title: lecturer
mesh term: Precancerous Conditions
sharing ipd: Undecided
provided document: 