<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/NCT02238574</url>
  </required_header>
  <id_info>
    <org_study_id>NL46343.068.13</org_study_id>
    <nct_id>NCT02238574</nct_id>
  </id_info>
  <brief_title>Diagnostics for the Treatment of Progressive Mucosal Lesions of the Oral Cavity: a Prospective Study</brief_title>
  <official_title>Chromosomal Instability as an Indicator for the Treatment of Progressive Mucosal Lesions of the Oral Cavity.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite improvements in therapy, head and neck carcinomas still have a poor prognosis with a&#xD;
      5-year survival of ~ 50%. Malignancies of the head and neck area are (almost) always preceded&#xD;
      by precursor lesions. Treatment of these premalignant mucosal abnormalities is generally&#xD;
      limited and not very inconvenient for the patient. If this precursor lesion remain untreated,&#xD;
      it may develop into a malignancy of the head and neck. Extensive treatment will be necessary.&#xD;
      This means loss of function of the mouth, eg chewing, speaking and swallowing.&#xD;
&#xD;
      The hypothesis is that chromosomal instability (CIN) detected by fluorescence is situ&#xD;
      hybridization (FISH) is a reliable indicator for progression to malignancy. By intensifying&#xD;
      the follow up and treatment in premalignant CIN lesions, the incidence of progression to&#xD;
      invasive carcinoma is expected to be significantly reduced. If this hypothesis is justified,&#xD;
      there will be a place for CIN detection as a risk indicator in the diagnostic work up of&#xD;
      premalignant lesions in the head and neck.&#xD;
&#xD;
      The investigators second hypothesis is that loss of heterozygosity (LOH) detected bij DNA&#xD;
      markers is a reliable indicator for progression to malignancy. By intensifying the outpatient&#xD;
      clinic follow up and treatment in premalignant lesions, the incidence of progression to&#xD;
      invasive carcinoma is expected to be significantly reduced. If this hypothesis is justified,&#xD;
      there will be a place for CIN and LOH detection as a risk indicator in the diagnostic work up&#xD;
      of premalignant lesions in the head and neck.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of funding&#xD;
  </why_stopped>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients (CIN negative and positive) who will show progression to malignancy of the oral cavity.</measure>
    <time_frame>1 year</time_frame>
    <description>The primary goal of this prospective study is:&#xD;
Demonstrating the predictive value of the detection of CIN in premalignant lesions of the oral cavity by the use of FISH for the occurrence of progression to severe dysplasia /CIS or invasive carcinoma.&#xD;
The prevention of progression of premalignant lesions of the oral cavity to severe dysplasia / CIS or invasive carcinoma by the treatment of selected high-risk lesions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients (LOH negative and positive) who will show progression to malignancy of the oral cavity.</measure>
    <time_frame>1 year</time_frame>
    <description>The secondary objective of this study is as follows:&#xD;
Demonstrating the predictive value of the detection of LOH in premalignant lesions of the oral cavity by the use of DNA markers for the occurrence of progression to severe dysplasia / CIS or invasive carcinoma.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Chromosomal Instability</condition>
  <condition>Low Grade Dysplasia Oral Cavity</condition>
  <condition>Loss of Heterozygostiy</condition>
  <condition>Fluorescence In Situ Hybridization</condition>
  <arm_group>
    <arm_group_label>follow up &amp; surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CIN positive with surgery and intensified follow up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>follow up</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CIN positive, only intensified outpatient follow up</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>surgery</intervention_name>
    <description>excision or carbondioxide laser evaporation of the mucosal lesion of the oral cavity</description>
    <arm_group_label>follow up &amp; surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>follow up</intervention_name>
    <description>Intensified outpatient follow up (16 visits in 5 years)</description>
    <arm_group_label>follow up</arm_group_label>
    <arm_group_label>follow up &amp; surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects ≥18 years&#xD;
&#xD;
          -  premalignant lesions of the oral cavity, classified as hyperkeratosis, hyperplasia,&#xD;
             mild or moderate dysplasia&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  former malignancy or lesion classified as severe dysplasia or carcinoma in situ at the&#xD;
             same anatomical localization of the oral cavity&#xD;
&#xD;
          -  lesions within an anatomical field which has been exposed to former treatment (e.g.&#xD;
             radiotherapy)&#xD;
&#xD;
          -  insufficient biopsy material to perform additional FISH analysis&#xD;
&#xD;
          -  pregnancy, because of the physical burden (e.g. extra general anesthesia) in this&#xD;
             study setting&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maarten Borgemeester, MD</last_name>
    <role>Study Director</role>
    <affiliation>University medical centre Maastricht</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maastricht Universitair Medisch Centrum (MUMC)</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>6202</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>January 5, 2018</last_update_submitted>
  <last_update_submitted_qc>January 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chromosomal Instability</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/NCT02238574
org study id: NL46343.068.13
nct id: NCT02238574
lead sponsor: 
has dmc: Yes
Despite improvements in therapy, head and neck carcinomas still have a poor prognosis with a
      5-year survival of ~ 50%. Malignancies of the head and neck area are (almost) always preceded
      by precursor lesions. Treatment of these premalignant mucosal abnormalities is generally
      limited and not very inconvenient for the patient. If this precursor lesion remain untreated,
      it may develop into a malignancy of the head and neck. Extensive treatment will be necessary.
      This means loss of function of the mouth, eg chewing, speaking and swallowing.

      The hypothesis is that chromosomal instability (CIN) detected by fluorescence is situ
      hybridization (FISH) is a reliable indicator for progression to malignancy. By intensifying
      the follow up and treatment in premalignant CIN lesions, the incidence of progression to
      invasive carcinoma is expected to be significantly reduced. If this hypothesis is justified,
      there will be a place for CIN detection as a risk indicator in the diagnostic work up of
      premalignant lesions in the head and neck.

      The investigators second hypothesis is that loss of heterozygosity (LOH) detected bij DNA
      markers is a reliable indicator for progression to malignancy. By intensifying the outpatient
      clinic follow up and treatment in premalignant lesions, the incidence of progression to
      invasive carcinoma is expected to be significantly reduced. If this hypothesis is justified,
      there will be a place for CIN and LOH detection as a risk indicator in the diagnostic work up
      of premalignant lesions in the head and neck.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients (CIN negative and positive) who will show progression to malignancy of the oral cavity.
time frame: 1 year
description: The primary goal of this prospective study is:
Demonstrating the predictive value of the detection of CIN in premalignant lesions of the oral cavity by the use of FISH for the occurrence of progression to severe dysplasia /CIS or invasive carcinoma.
The prevention of progression of premalignant lesions of the oral cavity to severe dysplasia / CIS or invasive carcinoma by the treatment of selected high-risk lesions.
measure: Number of patients (LOH negative and positive) who will show progression to malignancy of the oral cavity.
time frame: 1 year
description: The secondary objective of this study is as follows:
Demonstrating the predictive value of the detection of LOH in premalignant lesions of the oral cavity by the use of DNA markers for the occurrence of progression to severe dysplasia / CIS or invasive carcinoma.
arm group label: follow up & surgery
arm group type: Experimental
description: CIN positive with surgery and intensified follow up
arm group label: follow up
arm group type: Active Comparator
description: CIN positive, only intensified outpatient follow up
intervention type: Procedure
intervention name: surgery
description: excision or carbondioxide laser evaporation of the mucosal lesion of the oral cavity
arm group label: follow up & surgery
intervention type: Other
intervention name: follow up
description: Intensified outpatient follow up (16 visits in 5 years)
arm group label: follow up
arm group label: follow up & surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maarten Borgemeester, MD
role: Study Director
affiliation: University medical centre Maastricht
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Chromosomal Instability