<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/NCT04447456</url>
  </required_header>
  <id_info>
    <org_study_id>2019_68</org_study_id>
    <secondary_id>2020-A00738-31</secondary_id>
    <nct_id>NCT04447456</nct_id>
  </id_info>
  <brief_title>Comparison of Voice Results at 5 Years of Treatment of Glottic Squamous Cell Carcinoma T1 by Surgery Versus Radiotherapy</brief_title>
  <acronym>VO Qual</acronym>
  <official_title>Comparison of Voice Results at 5 Years of Treatment of Glottic Squamous Cell Carcinoma T1 by Surgery Versus Radiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</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>
      Patients with early-stage squamous cell carcinomas of the vocal cord can be treated in an&#xD;
      equivalent way in terms of carcinology by surgery or radiotherapy. The study will be to&#xD;
      analyse the vocal outcome at 5 years of these two types of management in order to define&#xD;
      whether one is superior to the other on this criterion of voice quality after treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 3, 2020</start_date>
  <completion_date type="Actual">January 19, 2022</completion_date>
  <primary_completion_date type="Actual">January 19, 2022</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Voice Handicap Index</measure>
    <time_frame>At 5 years</time_frame>
    <description>The VHI is a self-administered questionnaire that provides a score ranging from 0 to 120 points validated in France and internationally based on the declarative answers to 30 items of the questionnaire. A high score corresponds to a voice felt to be of poor quality. This is a subjective assessment made by the patient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Phonation Time</measure>
    <time_frame>At 5 years</time_frame>
    <description>The TMP is the measurement in seconds of a vowel (/a/) held for as long as possible.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grade, Roughness, Breathiness, Asthenia, Strain, Instability SCORE (GRBASI Score)</measure>
    <time_frame>At 5 years</time_frame>
    <description>This score is obtained from an internationally and nationally validated hetero-assessment. It consists in the attribution by a listening jury made up of two people of a mark ranging from 0 to 3 for each of the 6 items: Grade, Roughness, Breathiness, Asthenia, Strain, Instability.&#xD;
A high score is associated with a voice perceived as bad by the audience.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acoustic Analysis by Vocalab software</measure>
    <time_frame>At 5 years</time_frame>
    <description>short recording of the patient's voice delivering a standardized speech on VOCALAB software validated by the scientific community.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">41</enrollment>
  <condition>Glottic Carcinoma</condition>
  <arm_group>
    <arm_group_label>Surgery</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Radiotherapy</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patients treated for glottic squamous cell carcinoma at Lille University Hospital and the&#xD;
        Oscar Lambret Centre between 2015 and 2017.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with glottic squamous cell carcinoma T1N0M0 who may benefit from treatment&#xD;
             with exclusive radiotherapy or exclusive surgery.&#xD;
&#xD;
          -  patients treated for these cancers at Lille University Hospital and the Oscar Lambret&#xD;
             Centre between 2015 and 2017.&#xD;
&#xD;
          -  Tis, T1a and T1b glottic squamous cell carcinomas according to the TNM 7th edition&#xD;
             classification in long-term survivors.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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>François Mouawad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Oscar Lambret</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Huriez, CHU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>February 3, 2023</last_update_submitted>
  <last_update_submitted_qc>February 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Glottic Squamous Cell Carcinoma</keyword>
  <keyword>Surgery</keyword>
  <keyword>Radiotherapy</keyword>
  <keyword>Voice</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>
  <!-- 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/NCT04447456
org study id: 2019_68
secondary id: 2020-A00738-31
nct id: NCT04447456
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with early-stage squamous cell carcinomas of the vocal cord can be treated in an
      equivalent way in terms of carcinology by surgery or radiotherapy. The study will be to
      analyse the vocal outcome at 5 years of these two types of management in order to define
      whether one is superior to the other on this criterion of voice quality after treatment.
observational model: Cohort
time perspective: Retrospective
measure: Voice Handicap Index
time frame: At 5 years
description: The VHI is a self-administered questionnaire that provides a score ranging from 0 to 120 points validated in France and internationally based on the declarative answers to 30 items of the questionnaire. A high score corresponds to a voice felt to be of poor quality. This is a subjective assessment made by the patient.
measure: Maximum Phonation Time
time frame: At 5 years
description: The TMP is the measurement in seconds of a vowel (/a/) held for as long as possible.
measure: Grade, Roughness, Breathiness, Asthenia, Strain, Instability SCORE (GRBASI Score)
time frame: At 5 years
description: This score is obtained from an internationally and nationally validated hetero-assessment. It consists in the attribution by a listening jury made up of two people of a mark ranging from 0 to 3 for each of the 6 items: Grade, Roughness, Breathiness, Asthenia, Strain, Instability.
A high score is associated with a voice perceived as bad by the audience.
measure: Acoustic Analysis by Vocalab software
time frame: At 5 years
description: short recording of the patient's voice delivering a standardized speech on VOCALAB software validated by the scientific community.
arm group label: Surgery
arm group label: Radiotherapy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: François Mouawad, MD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell