<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/NCT04503824</url>
  </required_header>
  <id_info>
    <org_study_id>14422019590827</org_study_id>
    <nct_id>NCT04503824</nct_id>
  </id_info>
  <brief_title>Assessing LncRNA DQ786243 and IL-17 Expression in Oral Lichen Planus: A Case Control Study</brief_title>
  <official_title>Assessing LncRNA DQ786243 and IL-17 Expression in Oral Lichen Planus: A Case Control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      Observational case-control study. The current study aims to assess the salivary expression of&#xD;
      lncRNA DQ786243 and IL-17 in OLP, to better understand the pathogenesis of OLP and provide&#xD;
      effective targets for OLP therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Oral lichen planus (OLP) is a common chronic inflammatory disease associated with&#xD;
      cell-mediated immunological dysfunction. OLP can be seen in different clinical presentations.&#xD;
      It can be classified as papular (reticular), atrophic (erythematous) and erosive (ulcerative,&#xD;
      bullous).1 Numerous predisposing factors have been blamed for causing OLP, including: stress,&#xD;
      diabetes, drugs, dental materials, autoimmune diseases, infectious agents and genetic&#xD;
      predisposition. 2 Regarding the pathogenesis of OLP, it is a T-cell mediated inflammatory&#xD;
      disease where antigen- specific and non-specific mechanisms are hypothesized to be involved3.&#xD;
      Antigen-specific mechanisms include antigen presentation by basal keratinocytes and&#xD;
      antigen-specific keratinocyte killing by CD8+ cytotoxic T-cells. Non-specific mechanisms&#xD;
      include mast cell degranulation, basement membrane disruption, chemokines and matrix&#xD;
      metalloproteinase (MMP) activation in OLP lesions.4 Various treatment regimens have been&#xD;
      proposed to improve the management of symptomatic OLP, but a permanent cure is not yet&#xD;
      available. Treatment regimens are non-specific and directed at eliminating inflammation and&#xD;
      immunosuppression.5 Corticosteroids constitute the main stay agent, other available treatment&#xD;
      modalities include immunosuppressants, cyclosporin, tacrolimus, and retinoids.6 Long&#xD;
      non-coding RNAs (lncRNAs) have been identified as new regulatory molecules. They modulate&#xD;
      protein coding gene at the chromatin remodeling level, or the transcriptional and post-&#xD;
      transcriptional control level. They play vital roles in cell differentiation, cell growth and&#xD;
      apoptosis. lncRNA DQ786243 is drawing attention in the pathogenesis of a variety of&#xD;
      inflammatory immune- mediated diseases such as Crohn's disease and OLP.7, 8 A recent study&#xD;
      suggested that lncRNA DQ786243 exert its function through interleukins (ILs) including IL-17.&#xD;
      T-helper 17 response and its hallmark IL-17 is gaining more evidence for its role and&#xD;
      association with many diseases such as&#xD;
&#xD;
      5 Crohn's disease, ulcerative colitis, systemic lupus erythematosus and OLP. IL-17 has been&#xD;
      found to participate in the development of autoimmune disease, inflammatory destruction and&#xD;
      tumor microenvironments.9, 10&#xD;
&#xD;
      Research question:&#xD;
&#xD;
      What is the salivary expression of lncRNA DQ786243 and IL-17 in Oral Lichen Planus?&#xD;
      Population (P): Oral lichen planus Control (C): Healthy individuals Outcome (O): Salivary&#xD;
      expression level of lncRNA DQ786243 and IL-17&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      The current study aims to assess the salivary expression of lncRNA DQ786243 and IL-17 in OLP,&#xD;
      to better understand the pathogenesis of OLP and provide effective targets for OLP therapy.&#xD;
&#xD;
      III. Methods:&#xD;
&#xD;
      7. Study design Observational case-control study. 8. Settings Participants will be recruited&#xD;
      from the diagnostic centre and Oral Medicine clinic of the Faculty of Dentistry- Cairo&#xD;
      University. The recruitment period is expected to extend from January 2020 to January 2021.&#xD;
&#xD;
      A) Participants 9. Eligibility criteria&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
        -  Patients diagnosed with OLP.&#xD;
&#xD;
        -  Patient who will agree to participate in the study.&#xD;
&#xD;
        -  Patients who will accept to sign the informed consent.&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        -  Patients suffering from any systemic disease.&#xD;
&#xD;
        -  Patients suffering from any local inflammatory disease or infection.&#xD;
&#xD;
        -  Pregnant and lactating women. ▪ Smokers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 5, 2020</start_date>
  <completion_date type="Anticipated">July 29, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 29, 2021</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Salivary expression of lncRNA DQ786243. Salivary expression of lncRNA DQ786243. Salivary expression of lncRNA DQ786243. Salivary expression of lncRNA DQ786243. ▪ Salivary expression of IL-17 and Salivary expression of lncRNA DQ786243.</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">52</enrollment>
  <condition>Patients With Oral Lichen Planus</condition>
  <arm_group>
    <arm_group_label>Group IIa: 13 papular OLP</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Group IIb: 13 atrophic OLP</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Group IIc: 13 erosive OLP</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Group I: 13 healthy individuals</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>saliva samples</intervention_name>
    <description>Salivary expression of lncRNA DQ786243 and IL-17 will be evaluated using qRT-PCR.</description>
    <arm_group_label>Group I: 13 healthy individuals</arm_group_label>
    <arm_group_label>Group IIa: 13 papular OLP</arm_group_label>
    <arm_group_label>Group IIb: 13 atrophic OLP</arm_group_label>
    <arm_group_label>Group IIc: 13 erosive OLP</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        thestudy composes of two groups: healthy controls and OLP. The expression of the two&#xD;
        markers will be compared between the two studied groups. In OLP group, the expression of&#xD;
        the two markers will be correlated with pain and clinical assessment scores. In addition,&#xD;
        OLP group will be subgrouped based on the clinical form: papular, atrophic, erosive. Data&#xD;
        of all participants will be entered on Excel sheet. Each participant will be provided an ID&#xD;
        number that will be used for data management and placed as a label for the samples.&#xD;
&#xD;
        Group I: 13 healthy individuals Group IIa: 13 papular OLP Group IIb: 13 atrophic OLP Group&#xD;
        IIc: 13 erosive OLP&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with OLP.&#xD;
&#xD;
               -  Patient who will agree to participate in the study.&#xD;
&#xD;
               -  Patients who will accept to sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients suffering from any systemic disease.&#xD;
&#xD;
               -  Patients suffering from any local inflammatory disease or infection.&#xD;
&#xD;
               -  Pregnant and lactating women. ▪ Smokers.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>engy abdeldayem</last_name>
    <phone>01222376959</phone>
    <email>engyabdeldayem@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <zip>12223</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>engy abdeldayem</last_name>
      <phone>01222376959</phone>
      <email>engyabdeldayem@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Engy Mahmoud Abdel Wahed Abdel dayem</investigator_full_name>
    <investigator_title>assistant lecterur</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lichen Planus, Oral</mesh_term>
    <mesh_term>Lichen Planus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04503824
org study id: 14422019590827
nct id: NCT04503824
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Observational case-control study. The current study aims to assess the salivary expression of
      lncRNA DQ786243 and IL-17 in OLP, to better understand the pathogenesis of OLP and provide
      effective targets for OLP therapy.
Oral lichen planus (OLP) is a common chronic inflammatory disease associated with
      cell-mediated immunological dysfunction. OLP can be seen in different clinical presentations.
      It can be classified as papular (reticular), atrophic (erythematous) and erosive (ulcerative,
      bullous).1 Numerous predisposing factors have been blamed for causing OLP, including: stress,
      diabetes, drugs, dental materials, autoimmune diseases, infectious agents and genetic
      predisposition. 2 Regarding the pathogenesis of OLP, it is a T-cell mediated inflammatory
      disease where antigen- specific and non-specific mechanisms are hypothesized to be involved3.
      Antigen-specific mechanisms include antigen presentation by basal keratinocytes and
      antigen-specific keratinocyte killing by CD8+ cytotoxic T-cells. Non-specific mechanisms
      include mast cell degranulation, basement membrane disruption, chemokines and matrix
      metalloproteinase (MMP) activation in OLP lesions.4 Various treatment regimens have been
      proposed to improve the management of symptomatic OLP, but a permanent cure is not yet
      available. Treatment regimens are non-specific and directed at eliminating inflammation and
      immunosuppression.5 Corticosteroids constitute the main stay agent, other available treatment
      modalities include immunosuppressants, cyclosporin, tacrolimus, and retinoids.6 Long
      non-coding RNAs (lncRNAs) have been identified as new regulatory molecules. They modulate
      protein coding gene at the chromatin remodeling level, or the transcriptional and post-
      transcriptional control level. They play vital roles in cell differentiation, cell growth and
      apoptosis. lncRNA DQ786243 is drawing attention in the pathogenesis of a variety of
      inflammatory immune- mediated diseases such as Crohn's disease and OLP.7, 8 A recent study
      suggested that lncRNA DQ786243 exert its function through interleukins (ILs) including IL-17.
      T-helper 17 response and its hallmark IL-17 is gaining more evidence for its role and
      association with many diseases such as

      5 Crohn's disease, ulcerative colitis, systemic lupus erythematosus and OLP. IL-17 has been
      found to participate in the development of autoimmune disease, inflammatory destruction and
      tumor microenvironments.9, 10

      Research question:

      What is the salivary expression of lncRNA DQ786243 and IL-17 in Oral Lichen Planus?
      Population (P): Oral lichen planus Control (C): Healthy individuals Outcome (O): Salivary
      expression level of lncRNA DQ786243 and IL-17

      Objectives:

      The current study aims to assess the salivary expression of lncRNA DQ786243 and IL-17 in OLP,
      to better understand the pathogenesis of OLP and provide effective targets for OLP therapy.

      III. Methods:

      7. Study design Observational case-control study. 8. Settings Participants will be recruited
      from the diagnostic centre and Oral Medicine clinic of the Faculty of Dentistry- Cairo
      University. The recruitment period is expected to extend from January 2020 to January 2021.

      A) Participants 9. Eligibility criteria

      Inclusion criteria:

        -  Patients diagnosed with OLP.

        -  Patient who will agree to participate in the study.

        -  Patients who will accept to sign the informed consent.

      Exclusion criteria:

        -  Patients suffering from any systemic disease.

        -  Patients suffering from any local inflammatory disease or infection.

        -  Pregnant and lactating women. ▪ Smokers.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Salivary expression of lncRNA DQ786243. Salivary expression of lncRNA DQ786243. Salivary expression of lncRNA DQ786243. Salivary expression of lncRNA DQ786243. ▪ Salivary expression of IL-17 and Salivary expression of lncRNA DQ786243.
time frame: one year
arm group label: Group IIa: 13 papular OLP
arm group label: Group IIb: 13 atrophic OLP
arm group label: Group IIc: 13 erosive OLP
arm group label: Group I: 13 healthy individuals
intervention type: Diagnostic Test
intervention name: saliva samples
description: Salivary expression of lncRNA DQ786243 and IL-17 will be evaluated using qRT-PCR.
arm group label: Group I: 13 healthy individuals
arm group label: Group IIa: 13 papular OLP
arm group label: Group IIb: 13 atrophic OLP
arm group label: Group IIc: 13 erosive OLP
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: engy abdeldayem
phone: 01222376959
email: engyabdeldayem@hotmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Engy Mahmoud Abdel Wahed Abdel dayem
investigator title: assistant lecterur
mesh term: Lichen Planus, Oral
mesh term: Lichen Planus
sharing ipd: Undecided