<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/NCT03288298</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2017-09-23</org_study_id>
    <nct_id>NCT03288298</nct_id>
  </id_info>
  <brief_title>Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line</brief_title>
  <official_title>Therapeutic Effect Of Luteolin Natural Extract Versus Its Nanoparticles On Tongue Squamous Cell Carcinoma Cell Line: In Vitro Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      In vitro study to examine whether luteolin and nano-luteolin exert an inhibitory effect on&#xD;
      tongue squamous cell carcinoma cell line by inducing apoptosis, and to assess if&#xD;
      nano-luteolin has more efficient apoptotic activity than luteolin on tongue squamous cell&#xD;
      carcinoma cell line.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is conducted to examine whether luteolin and nano-luteolin exert an inhibitory&#xD;
      effect on tongue squamous cell carcinoma cell line by inducing apoptosis, and to assess if&#xD;
      nano-luteolin has more efficient apoptotic activity than luteolin on tongue squamous cell&#xD;
      carcinoma cell line. The primary outcome is apoptosis, while the secondary outcome is cell&#xD;
      viability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 1, 2017</start_date>
  <completion_date type="Anticipated">April 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2018</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>gene expression of Caspase 3 to detect apoptosis</measure>
    <time_frame>6 hours</time_frame>
    <description>fold-changes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cell viability</measure>
    <time_frame>6 hours</time_frame>
    <description>micromolar</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">4</enrollment>
  <condition>Tongue Neoplasms</condition>
  <condition>Carcinoma</condition>
  <arm_group>
    <arm_group_label>luteolin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>a natural extract derived flavinoids</description>
  </arm_group>
  <arm_group>
    <arm_group_label>nano-luteolin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>nano-particles derived from a natural extract luteolin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>luteolin</intervention_name>
    <description>flavonoid natural extract</description>
    <arm_group_label>luteolin</arm_group_label>
    <other_name>3',4',5,7-tetrahydroxyflavone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>nano-luteolin</intervention_name>
    <description>nanoparticles of luteolin</description>
    <arm_group_label>nano-luteolin</arm_group_label>
    <other_name>nanoluteolin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Squamous cell carcinoma cell lines (OSCC, TSCC and HNSCC).&#xD;
&#xD;
          -  Luteolin 5,7,3',4'-tetrahydroxy-flavone (MeSH term).&#xD;
&#xD;
          -  Application of luteolin as a chemotherapeutic drug.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any cancer cell line other than OSCC, TSCC and HNSCC cell lines.&#xD;
&#xD;
          -  Luteolin glycosides.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Elkhadem, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Center for Evidence Based Dentistry</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Safaa M. Baz, Masters</last_name>
    <phone>002 01119777824</phone>
    <email>drsafaaelbaz@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Safa F. Abd El-Ghani, PhD</last_name>
    <phone>002 01005198010</phone>
    <email>drsafa.fathy@yahoo.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Ding S, Hu A, Hu Y, Ma J, Weng P, Dai J. Anti-hepatoma cells function of luteolin through inducing apoptosis and cell cycle arrest. Tumour Biol. 2014 Apr;35(4):3053-60. doi: 10.1007/s13277-013-1396-5. Epub 2013 Nov 28.</citation>
    <PMID>24287949</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>September 18, 2017</last_update_submitted>
  <last_update_submitted_qc>September 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Safaa Elbaz</investigator_full_name>
    <investigator_title>Assistant Lecturer, Oral and Maxillofacial Pathology, BUE</investigator_title>
  </responsible_party>
  <keyword>TSCC</keyword>
  <keyword>OSCC</keyword>
  <keyword>luteolin</keyword>
  <keyword>nanoluteolin</keyword>
  <keyword>nanotechnology</keyword>
  <keyword>oral cancer</keyword>
  <keyword>apoptosis</keyword>
  <keyword>PCR</keyword>
  <keyword>MTT</keyword>
  <keyword>ELISA reader</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Tongue Neoplasms</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 18, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT03288298/Prot_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/NCT03288298
org study id: CEBD-CU-2017-09-23
nct id: NCT03288298
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In vitro study to examine whether luteolin and nano-luteolin exert an inhibitory effect on
      tongue squamous cell carcinoma cell line by inducing apoptosis, and to assess if
      nano-luteolin has more efficient apoptotic activity than luteolin on tongue squamous cell
      carcinoma cell line.
This study is conducted to examine whether luteolin and nano-luteolin exert an inhibitory
      effect on tongue squamous cell carcinoma cell line by inducing apoptosis, and to assess if
      nano-luteolin has more efficient apoptotic activity than luteolin on tongue squamous cell
      carcinoma cell line. The primary outcome is apoptosis, while the secondary outcome is cell
      viability.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: gene expression of Caspase 3 to detect apoptosis
time frame: 6 hours
description: fold-changes
measure: cell viability
time frame: 6 hours
description: micromolar
arm group label: luteolin
arm group type: Experimental
description: a natural extract derived flavinoids
arm group label: nano-luteolin
arm group type: Active Comparator
description: nano-particles derived from a natural extract luteolin
intervention type: Drug
intervention name: luteolin
description: flavonoid natural extract
arm group label: luteolin
other name: 3',4',5,7-tetrahydroxyflavone
intervention type: Drug
intervention name: nano-luteolin
description: nanoparticles of luteolin
arm group label: nano-luteolin
other name: nanoluteolin
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ahmed Elkhadem, PhD
role: Study Chair
affiliation: Center for Evidence Based Dentistry
last name: Safaa M. Baz, Masters
phone: 002 01119777824
email: drsafaaelbaz@gmail.com
last name: Safa F. Abd El-Ghani, PhD
phone: 002 01005198010
email: drsafa.fathy@yahoo.com
citation: Ding S, Hu A, Hu Y, Ma J, Weng P, Dai J. Anti-hepatoma cells function of luteolin through inducing apoptosis and cell cycle arrest. Tumour Biol. 2014 Apr;35(4):3053-60. doi: 10.1007/s13277-013-1396-5. Epub 2013 Nov 28.
PMID: 24287949
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Safaa Elbaz
investigator title: Assistant Lecturer, Oral and Maxillofacial Pathology, BUE
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Tongue Neoplasms
provided document: 