<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/NCT01695018</url>
  </required_header>
  <id_info>
    <org_study_id>PKUSSOM20120711</org_study_id>
    <nct_id>NCT01695018</nct_id>
  </id_info>
  <brief_title>Early Diagnosis of Oral Cancer by Detecting p16 Methylation</brief_title>
  <official_title>A Multicentral Prospective Study on Prediction of Malignant Progression of Oral Epithelial Dysplasia With p16 Methylation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to verify the function of p16 methylation diagnostic reagents in&#xD;
      early diagnosis of oral cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:Oral epithelial dysplasia (OED) is one of the common precancerous lesions among&#xD;
      Chinese adults. To investigate the clinical predictive value of p16 methylation diagnostic&#xD;
      reagents in the early diagnosis of oral cancer, the investigators carried out the prospective&#xD;
      multi-center double-blind cohort study.&#xD;
&#xD;
      Methods:180 patients with histologically confirmed mild or moderate OED were included in the&#xD;
      present study. The investigators using p16 methylation diagnostic reagents to analysis of the&#xD;
      p16 methylation status in these patients. Building two follow-up queue by p16-methylated and&#xD;
      p16-unmethylated. The Statistical analysis used SAS6.12 software. All P-values were&#xD;
      two-sided. P&lt;0.05 was considered to test for statistical significance difference.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2009</start_date>
  <primary_completion_date type="Actual">March 2014</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>Cancer rate in patients with oral epithelial dysplasia containing or NOT containing p16 methylation</measure>
    <time_frame>frome 3 months to 63 months</time_frame>
    <description>152 participants were p16 methylated informative. 29 participants were NOT informative because enough DNA was not extracted from their paraffin slides.&#xD;
Among these informative cases, oral specimens from 48 patients were p16 methylation positive and 104 patients were p16 methylation negative. The cancer rate in the p16 methylation positive patients during the followup period will be compared with that in the p16 methylation negative patients statistically.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">180</enrollment>
  <condition>Moderate Epithelial Dysplasia</condition>
  <condition>Mild Epithelial Dysplasia</condition>
  <arm_group>
    <arm_group_label>p16 methylation positive</arm_group_label>
    <description>48 patients with mild or moderate oral epithelial dysplasia containing methylated p16.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>p16 methylation negative</arm_group_label>
    <description>104 patients with p16 mild or moderate oral epithelial dysplasia NOT containing methylated p16.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Oral mucosal biopsy tissues were formalin fixed , paraffin embedded , sliced and&#xD;
      hematoxylin-eosin (HE) staining.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        180 patients with mild or moderate oral epithelial dysplasia were selected. 81 of them were&#xD;
        from Peking University of Stomatology and 68 were from Capital Medical University School of&#xD;
        Stomatology and other 31 were from Fourth Military Medical University School of&#xD;
        Stomatology.All of the patients with OED had been diagnosed pathologically by at least two&#xD;
        senior pathologists using the criteria from '2005 WHO Classification System' and The oral&#xD;
        tissue pathology diagnostic criteria (oral histopathology Edition Sixth).All cases involved&#xD;
        primary lesions without any LASER, radiation therapy or chemotherapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histopathological diagnosis of oral lesions meet the epithelial diagnostic criteria&#xD;
             for mild to moderate grade OED&#xD;
&#xD;
          -  No local area stimulate by residual root and crown, sharp cusp, poor restoration and&#xD;
             biting cheek or lips&#xD;
&#xD;
          -  Without the OCE treatment history by laser , radiation or chemical&#xD;
&#xD;
          -  Be able to Sign the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Histopathological diagnosis of oral lesions do not meet the epithelium of mild to&#xD;
             moderate dysplasia diagnostic criteria; histological diagnosis of severe grade OED or&#xD;
             malignant disease&#xD;
&#xD;
          -  Pregnancy or breast-feeding women&#xD;
&#xD;
          -  Serious heart, lung, liver , kidney and other systemic diseases&#xD;
&#xD;
          -  local area stimulate by residual root and crown, sharp cusp, poor restoration and&#xD;
             biting cheek or lips&#xD;
&#xD;
          -  OED treatment history by LASER, radiotherapy, or chemotherapy&#xD;
&#xD;
          -  Tumor and psychiatric patients&#xD;
&#xD;
          -  Patients are unable to cooperate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>78 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dajun Deng, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University</affiliation>
  </overall_official>
  <link>
    <url>http://www.pku.edu.cn</url>
    <description>Peking University</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>September 24, 2014</last_update_submitted>
  <last_update_submitted_qc>September 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Hongwei Liu, MD, PhD</investigator_full_name>
    <investigator_title>Peking University School and Hospital of Stomatology</investigator_title>
  </responsible_party>
  <keyword>oral epithelial dysplasia</keyword>
  <keyword>p16 methylation</keyword>
  <keyword>diagnostic reagents</keyword>
  <keyword>early diagnosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma in Situ</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
  </condition_browse>
  <!-- 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/NCT01695018
org study id: PKUSSOM20120711
nct id: NCT01695018
lead sponsor: 
has dmc: Yes
The purpose of this study is to verify the function of p16 methylation diagnostic reagents in
      early diagnosis of oral cancer.
Background:Oral epithelial dysplasia (OED) is one of the common precancerous lesions among
      Chinese adults. To investigate the clinical predictive value of p16 methylation diagnostic
      reagents in the early diagnosis of oral cancer, the investigators carried out the prospective
      multi-center double-blind cohort study.

      Methods:180 patients with histologically confirmed mild or moderate OED were included in the
      present study. The investigators using p16 methylation diagnostic reagents to analysis of the
      p16 methylation status in these patients. Building two follow-up queue by p16-methylated and
      p16-unmethylated. The Statistical analysis used SAS6.12 software. All P-values were
      two-sided. P<0.05 was considered to test for statistical significance difference.
observational model: Cohort
time perspective: Prospective
measure: Cancer rate in patients with oral epithelial dysplasia containing or NOT containing p16 methylation
time frame: frome 3 months to 63 months
description: 152 participants were p16 methylated informative. 29 participants were NOT informative because enough DNA was not extracted from their paraffin slides.
Among these informative cases, oral specimens from 48 patients were p16 methylation positive and 104 patients were p16 methylation negative. The cancer rate in the p16 methylation positive patients during the followup period will be compared with that in the p16 methylation negative patients statistically.
arm group label: p16 methylation positive
description: 48 patients with mild or moderate oral epithelial dysplasia containing methylated p16.
arm group label: p16 methylation negative
description: 104 patients with p16 mild or moderate oral epithelial dysplasia NOT containing methylated p16.
Oral mucosal biopsy tissues were formalin fixed , paraffin embedded , sliced and
      hematoxylin-eosin (HE) staining.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 25 Years
maximum age: 78 Years
healthy volunteers: No
last name: Dajun Deng, MD
role: Principal Investigator
affiliation: Peking University
url: http://www.pku.edu.cn
description: Peking University
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Hongwei Liu, MD, PhD
investigator title: Peking University School and Hospital of Stomatology
mesh term: Carcinoma in Situ
mesh term: Hyperplasia