<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/NCT03837613</url>
  </required_header>
  <id_info>
    <org_study_id>MohamedGhorabMSc</org_study_id>
    <nct_id>NCT03837613</nct_id>
  </id_info>
  <brief_title>Prognostic Value of Tumor Thickness of Buccal Mucosa Squamous Cell Carcinoma on the Incidence of Nodal Metastasis.</brief_title>
  <official_title>Prognostic Value of Tumor Thickness of Buccal Mucosa Squamous Cell Carcinoma on the Incidence of Nodal Metastasis in the Neck: A Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mohamed Ghorab</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cairo 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>
      Does the tumor thickness value of buccal squamous cell carcinomas, predict cervical nodal&#xD;
      metastasis in clinically and radio-graphical neck negative (N0) thus sparing such patients&#xD;
      unnecessary surgical procedures and it's associated morbidities? The aim of the study is to&#xD;
      evaluate the prognostic value of tumor thickness cut off 4 mm in predicting cervical nodal&#xD;
      metastases in a population of Egyptian patients presenting with Buccal Squamous Cell&#xD;
      Carcinoma. The hypothesis is that patients with tumor thickness less than 4 mm will present&#xD;
      with significantly less cervical nodal metastasis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be recruited from the outpatient clinics of Al Monofia university hospital,&#xD;
      Cairo University Hospital and National Cancer Institute. Patients who fits the inclusion&#xD;
      criteria and are motivated and consent to enter the study will be included. Patient&#xD;
      recruitment will continue until the target sample size is reached.&#xD;
&#xD;
      Patients data will be collected including personal data, medical history, family history, and&#xD;
      classification of the tumor according to the TNM classification system. Patients will be&#xD;
      assessed preoperatively with a transcutaneous high frequency probe ultrasound to measure the&#xD;
      maximal tumor thickness in millimeters using a 10MHz superficial probe and the lymph nodes in&#xD;
      the neck region. In addition to clinical examination and palpation of the neck lymph nodes.&#xD;
      Patients will then undergo tumor resection surgery with adequate safety margins under GA with&#xD;
      nasotracheal intubation. Selective neck dissection will then be performed. The specimens will&#xD;
      be submitted for histopathological examination.&#xD;
&#xD;
      Patients will receive standard post operative care based on the recommendation of the&#xD;
      oncologist. Adjunct chemo or radiotherapy will be administered when deemed necessary. Wound&#xD;
      care and dressings will be administered as needed.&#xD;
&#xD;
      Patients will be categorized into two groups based on the tumor thickness (exposure).&#xD;
&#xD;
      For the primary outcome, the data source will be the measurement of tumor depth based on&#xD;
      Berslow method as discussed in the review of literature, obtained from ultrasonography and&#xD;
      recorded in millimeters.Tumor width recorded in (mm) will also be obtained from the&#xD;
      ultrasonography as it may be a source of confounders. Further, histological grade of the&#xD;
      lesion will also be recorded.&#xD;
&#xD;
      Two confounding factors are highlighted and may be sources of bias and attempt to control for&#xD;
      them in the statistical analyses will be made.&#xD;
&#xD;
      Appropriate statistical methods will be used after collection of the data and sources of&#xD;
      confounders will be controlled for during analyses in subgroup An attempt to control for&#xD;
      tumor width and histological grade in subgroup analyses&#xD;
&#xD;
      All data will be entered electronically. Patients' files are to be stored in numerical order&#xD;
      and stored in secure and accessible place. All data will be maintained in storage for 1 year&#xD;
      after completion of the study. Data monitoring committee is independent from the sponsor and&#xD;
      competing interest.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2019</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cervical nodal metastasis</measure>
    <time_frame>one week after the surgery</time_frame>
    <description>Number of patients with positive cervical nodal metastasis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tumor thickness</measure>
    <time_frame>one week after the surgery</time_frame>
    <description>Correlation between the tumor thickness measured preoperatively by ultrasound versus the tumor thickness measured from the histopathological specimen</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Cancer</condition>
  <condition>Squamous Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Group 1 (TT&lt;4mm)</arm_group_label>
    <description>Patients with a preoperative tumor thickness less than 4 mm. Intervention: tumor resection and neck dissection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 (TT &gt;= 4mm)</arm_group_label>
    <description>Patients with a preoperative tumor thickness equal to or more than 4 mm Intervention: tumor resection and neck dissection</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>tumor resection and neck dissection</intervention_name>
    <description>Surgical removal of the tumor with adequate safety margins. In addition to neck dissection to dissect the cervical lymph nodes.</description>
    <arm_group_label>Group 1 (TT&lt;4mm)</arm_group_label>
    <arm_group_label>Group 2 (TT &gt;= 4mm)</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tumor tissue and the dissected cervical lymph nodes retained for histopathological study.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Egyptians Patients presenting to Cairo University dental Hospital, National Cancer&#xD;
        Institute, and Al Monofia university hospital who fits the eligibility criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Egyptian patients with BSCC (T all N0) not previously operated or treated with&#xD;
             adjunctive therapy. They should present with no clinical signs of neck lymph nodes&#xD;
             involvement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with lesions secondary to another primary site.&#xD;
&#xD;
          -  Patients previously removed a primary oral surgery tumor in another site&#xD;
&#xD;
          -  Patients with clinical or radiographic evidence of cervical nodal metastases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed Ghorab, BSD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohamed Ghorab, BDS</last_name>
    <phone>01002841441</phone>
    <email>ddsmghorab@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cairo University - Faculty of Oral and Dental Medicine</name>
      <address>
        <city>Cairo</city>
        <zip>12111</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Mohamed Ghorab, BDS</last_name>
      <phone>01002841441</phone>
      <email>ddsmghorab@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Huang SH, Hwang D, Lockwood G, Goldstein DP, O'Sullivan B. Predictive value of tumor thickness for cervical lymph-node involvement in squamous cell carcinoma of the oral cavity: a meta-analysis of reported studies. Cancer. 2009 Apr 1;115(7):1489-97. doi: 10.1002/cncr.24161.</citation>
    <PMID>19197973</PMID>
  </reference>
  <reference>
    <citation>Ota Y, Aoki T, Karakida K, Otsuru M, Kurabayashi H, Sasaki M, Nakamura N, Kajiwara H. Determination of deep surgical margin based on anatomical architecture for local control of squamous cell carcinoma of the buccal mucosa. Oral Oncol. 2009 Jul;45(7):605-9. doi: 10.1016/j.oraloncology.2008.08.010. Epub 2008 Nov 20.</citation>
    <PMID>19026588</PMID>
  </reference>
  <reference>
    <citation>Deshpande G, Das S. Tumor Thickness: A predictor of nodal disease in early squamous cell carcinomas of buccal mucosa. Gulf J Oncolog. 2015 May;1(18):37-43.</citation>
    <PMID>26003104</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 8, 2019</last_update_submitted>
  <last_update_submitted_qc>February 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mohamed Ghorab</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>cancer</keyword>
  <keyword>squamous cell carcinoma</keyword>
  <keyword>ultrasound</keyword>
  <keyword>tumor thickness</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>
  </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/NCT03837613
org study id: MohamedGhorabMSc
nct id: NCT03837613
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Does the tumor thickness value of buccal squamous cell carcinomas, predict cervical nodal
      metastasis in clinically and radio-graphical neck negative (N0) thus sparing such patients
      unnecessary surgical procedures and it's associated morbidities? The aim of the study is to
      evaluate the prognostic value of tumor thickness cut off 4 mm in predicting cervical nodal
      metastases in a population of Egyptian patients presenting with Buccal Squamous Cell
      Carcinoma. The hypothesis is that patients with tumor thickness less than 4 mm will present
      with significantly less cervical nodal metastasis.
Patients will be recruited from the outpatient clinics of Al Monofia university hospital,
      Cairo University Hospital and National Cancer Institute. Patients who fits the inclusion
      criteria and are motivated and consent to enter the study will be included. Patient
      recruitment will continue until the target sample size is reached.

      Patients data will be collected including personal data, medical history, family history, and
      classification of the tumor according to the TNM classification system. Patients will be
      assessed preoperatively with a transcutaneous high frequency probe ultrasound to measure the
      maximal tumor thickness in millimeters using a 10MHz superficial probe and the lymph nodes in
      the neck region. In addition to clinical examination and palpation of the neck lymph nodes.
      Patients will then undergo tumor resection surgery with adequate safety margins under GA with
      nasotracheal intubation. Selective neck dissection will then be performed. The specimens will
      be submitted for histopathological examination.

      Patients will receive standard post operative care based on the recommendation of the
      oncologist. Adjunct chemo or radiotherapy will be administered when deemed necessary. Wound
      care and dressings will be administered as needed.

      Patients will be categorized into two groups based on the tumor thickness (exposure).

      For the primary outcome, the data source will be the measurement of tumor depth based on
      Berslow method as discussed in the review of literature, obtained from ultrasonography and
      recorded in millimeters.Tumor width recorded in (mm) will also be obtained from the
      ultrasonography as it may be a source of confounders. Further, histological grade of the
      lesion will also be recorded.

      Two confounding factors are highlighted and may be sources of bias and attempt to control for
      them in the statistical analyses will be made.

      Appropriate statistical methods will be used after collection of the data and sources of
      confounders will be controlled for during analyses in subgroup An attempt to control for
      tumor width and histological grade in subgroup analyses

      All data will be entered electronically. Patients' files are to be stored in numerical order
      and stored in secure and accessible place. All data will be maintained in storage for 1 year
      after completion of the study. Data monitoring committee is independent from the sponsor and
      competing interest.
observational model: Cohort
time perspective: Prospective
measure: Cervical nodal metastasis
time frame: one week after the surgery
description: Number of patients with positive cervical nodal metastasis
measure: Tumor thickness
time frame: one week after the surgery
description: Correlation between the tumor thickness measured preoperatively by ultrasound versus the tumor thickness measured from the histopathological specimen
arm group label: Group 1 (TT<4mm)
description: Patients with a preoperative tumor thickness less than 4 mm. Intervention: tumor resection and neck dissection
arm group label: Group 2 (TT >= 4mm)
description: Patients with a preoperative tumor thickness equal to or more than 4 mm Intervention: tumor resection and neck dissection
intervention type: Procedure
intervention name: tumor resection and neck dissection
description: Surgical removal of the tumor with adequate safety margins. In addition to neck dissection to dissect the cervical lymph nodes.
arm group label: Group 1 (TT<4mm)
arm group label: Group 2 (TT >= 4mm)
Tumor tissue and the dissected cervical lymph nodes retained for histopathological study.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mohamed Ghorab, BSD
role: Principal Investigator
affiliation: Cairo University
last name: Mohamed Ghorab, BDS
phone: 01002841441
email: ddsmghorab@gmail.com
facility: 
contact: 
country: Egypt
citation: Huang SH, Hwang D, Lockwood G, Goldstein DP, O'Sullivan B. Predictive value of tumor thickness for cervical lymph-node involvement in squamous cell carcinoma of the oral cavity: a meta-analysis of reported studies. Cancer. 2009 Apr 1;115(7):1489-97. doi: 10.1002/cncr.24161.
PMID: 19197973
citation: Ota Y, Aoki T, Karakida K, Otsuru M, Kurabayashi H, Sasaki M, Nakamura N, Kajiwara H. Determination of deep surgical margin based on anatomical architecture for local control of squamous cell carcinoma of the buccal mucosa. Oral Oncol. 2009 Jul;45(7):605-9. doi: 10.1016/j.oraloncology.2008.08.010. Epub 2008 Nov 20.
PMID: 19026588
citation: Deshpande G, Das S. Tumor Thickness: A predictor of nodal disease in early squamous cell carcinomas of buccal mucosa. Gulf J Oncolog. 2015 May;1(18):37-43.
PMID: 26003104
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: Mohamed Ghorab
investigator title: Principal Investigator
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
sharing ipd: Undecided