<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/NCT02967120</url>
  </required_header>
  <id_info>
    <org_study_id>XM201303</org_study_id>
    <nct_id>NCT02967120</nct_id>
  </id_info>
  <brief_title>Early Diagnosis of Oral Cancer by Detecting p16 Hydroxymethylation</brief_title>
  <official_title>A Multicentral Prospective Study on Prediction of Malignant Progression of Oral Epithelial Dysplasia With p16 Hydroxymethylation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Municipal Administration of Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Municipal Administration of Hospitals</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 hydroxymethylation diagnostic&#xD;
      reagents in 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 hydroxymethylation&#xD;
      diagnostic reagents in the early diagnosis of oral cancer, the investigators carried out the&#xD;
      prospective multi-center double-blind cohort study.&#xD;
&#xD;
      Methods:265 patients with histologically confirmed mild or moderate OED were included in the&#xD;
      present study. After the bisulfite modification and tet assistant bisulfite modification,&#xD;
      MethyLight and Methylation-specific PCR (MSP) assays were used to analyze p16 methylation and&#xD;
      status in these patients. Building three follow-up queue by p16-methylated,&#xD;
      p16-hydroxymethylation and p16-unmethylated. The Statistical analysis used SPSS16.0. All&#xD;
      P-values were two-sided. P&lt;0.05 was considered to test for statistical significance&#xD;
      difference.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</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 hydroxymethylation</measure>
    <time_frame>from 3 months to 60 months</time_frame>
    <description>Among these cases, oral specimens from 24 patients were p16-hydroxymethylation, 54 patients were p16-methylation and 187 patients were p16-unmethylation. The cancer rate in the p16-hydroxymethylation patients during the followup period will be compared with that in the other two groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease free survival of patients with oral epithelial dysplasia containing or Not containing p16 hydroxymethylation</measure>
    <time_frame>from 3 months and 36 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">265</enrollment>
  <condition>Oral Epithelial Dysplasia</condition>
  <arm_group>
    <arm_group_label>p16 hydroxymethylation status</arm_group_label>
    <description>patients with p16 hydroxymethylation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention</intervention_name>
    <arm_group_label>p16 hydroxymethylation status</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Oral mucosal biopsy tissues were formalin fixed , paraffin embedded , sliced；or frozen&#xD;
      tissues;&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        336 patients with mild or moderate oral epithelial dysplasia were selected. 145 of them are&#xD;
        collected from Peking University of Stomatology and 165 were from Capital Medical&#xD;
        University School of Stomatology and other 26 were from Fourth Military Medical University&#xD;
        School of Stomatology.All of the patients with OED had been diagnosed pathologically by at&#xD;
        least two senior pathologists using the criteria from '2005 WHO Classification System' and&#xD;
        The oral tissue pathology diagnostic criteria (oral histopathology Edition Sixth).All cases&#xD;
        involved 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 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 local area stimulate&#xD;
             by residual root and crown, sharp cusp, poor restoration and 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>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dajun Deng, MD</last_name>
    <role>Study Director</role>
    <affiliation>Peking University Cancer Hosptial and Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhaojun Liu, PhD</last_name>
    <phone>86-010-88196721</phone>
    <email>liuzhaojun@bjmu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking University Cancer Hosptial and Institute</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhaojun Liu, Ph.D</last_name>
      <phone>86-010-88196721</phone>
      <email>liuzhaojun@bjmu.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>Dajun Deng, M.D</last_name>
      <phone>86-010-88196752</phone>
      <email>dengdajun@bjmu.edu.cn</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Liu H, Liu XW, Dong G, Zhou J, Liu Y, Gao Y, Liu XY, Gu L, Sun Z, Deng D. P16 Methylation as an Early Predictor for Cancer Development From Oral Epithelial Dysplasia: A Double-blind Multicentre Prospective Study. EBioMedicine. 2015 Mar 23;2(5):432-7. doi: 10.1016/j.ebiom.2015.03.015. eCollection 2015 May.</citation>
    <PMID>26137587</PMID>
  </reference>
  <reference>
    <citation>Cao J, Zhou J, Gao Y, Gu L, Meng H, Liu H, Deng D. Methylation of p16 CpG island associated with malignant progression of oral epithelial dysplasia: a prospective cohort study. Clin Cancer Res. 2009 Aug 15;15(16):5178-83. doi: 10.1158/1078-0432.CCR-09-0580. Epub 2009 Aug 11.</citation>
    <PMID>19671846</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>September 20, 2017</last_update_submitted>
  <last_update_submitted_qc>September 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Municipal Administration of Hospitals</investigator_affiliation>
    <investigator_full_name>Zhaojun Liu</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma in Situ</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The number of the participants of different groups and the followup information will be shared with other researchers after the end of the study.</ipd_description>
  </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/NCT02967120
org study id: XM201303
nct id: NCT02967120
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to verify the function of p16 hydroxymethylation 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 hydroxymethylation
      diagnostic reagents in the early diagnosis of oral cancer, the investigators carried out the
      prospective multi-center double-blind cohort study.

      Methods:265 patients with histologically confirmed mild or moderate OED were included in the
      present study. After the bisulfite modification and tet assistant bisulfite modification,
      MethyLight and Methylation-specific PCR (MSP) assays were used to analyze p16 methylation and
      status in these patients. Building three follow-up queue by p16-methylated,
      p16-hydroxymethylation and p16-unmethylated. The Statistical analysis used SPSS16.0. 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 hydroxymethylation
time frame: from 3 months to 60 months
description: Among these cases, oral specimens from 24 patients were p16-hydroxymethylation, 54 patients were p16-methylation and 187 patients were p16-unmethylation. The cancer rate in the p16-hydroxymethylation patients during the followup period will be compared with that in the other two groups.
measure: Disease free survival of patients with oral epithelial dysplasia containing or Not containing p16 hydroxymethylation
time frame: from 3 months and 36 months
arm group label: p16 hydroxymethylation status
description: patients with p16 hydroxymethylation
intervention type: Other
intervention name: no intervention
arm group label: p16 hydroxymethylation status
Oral mucosal biopsy tissues were formalin fixed , paraffin embedded , sliced；or frozen
      tissues;
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 25 Years
maximum age: N/A
healthy volunteers: No
last name: Dajun Deng, MD
role: Study Director
affiliation: Peking University Cancer Hosptial and Institute
last name: Zhaojun Liu, PhD
phone: 86-010-88196721
email: liuzhaojun@bjmu.edu.cn
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
citation: Liu H, Liu XW, Dong G, Zhou J, Liu Y, Gao Y, Liu XY, Gu L, Sun Z, Deng D. P16 Methylation as an Early Predictor for Cancer Development From Oral Epithelial Dysplasia: A Double-blind Multicentre Prospective Study. EBioMedicine. 2015 Mar 23;2(5):432-7. doi: 10.1016/j.ebiom.2015.03.015. eCollection 2015 May.
PMID: 26137587
citation: Cao J, Zhou J, Gao Y, Gu L, Meng H, Liu H, Deng D. Methylation of p16 CpG island associated with malignant progression of oral epithelial dysplasia: a prospective cohort study. Clin Cancer Res. 2009 Aug 15;15(16):5178-83. doi: 10.1158/1078-0432.CCR-09-0580. Epub 2009 Aug 11.
PMID: 19671846
responsible party type: Principal Investigator
investigator affiliation: Beijing Municipal Administration of Hospitals
investigator full name: Zhaojun Liu
investigator title: PhD
mesh term: Carcinoma in Situ
sharing ipd: Yes
ipd description: The number of the participants of different groups and the followup information will be shared with other researchers after the end of the study.