Comparison of Voice Results at 5 Years of Treatment of Glottic Squamous Cell Carcinoma T1 by Surgery Versus Radiotherapy (VO Qual)

April 17, 2026 updated by: University Hospital, Lille
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59000
        • Centre Oscar Lambret
      • Lille, France
        • Hôpital Huriez, CHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients treated for glottic squamous cell carcinoma at Lille University Hospital and the Oscar Lambret Centre between 2015 and 2017.

Description

Inclusion Criteria:

  • Patients with glottic squamous cell carcinoma T1N0M0 who may benefit from treatment with exclusive radiotherapy or exclusive surgery.
  • patients treated for these cancers at Lille University Hospital and the Oscar Lambret Centre between 2015 and 2017.
  • Tis, T1a and T1b glottic squamous cell carcinomas according to the TNM 7th edition classification in long-term survivors.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Surgery
Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Voice Handicap Index
Time Frame: At 5 years
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.
At 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Phonation Time
Time Frame: At 5 years
The TMP is the measurement in seconds of a vowel (/a/) held for as long as possible.
At 5 years
Grade, Roughness, Breathiness, Asthenia, Strain, Instability SCORE (GRBASI Score)
Time Frame: At 5 years

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.
At 5 years
Acoustic Analysis by Vocalab software
Time Frame: At 5 years
short recording of the patient's voice delivering a standardized speech on VOCALAB software validated by the scientific community.
At 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: François Mouawad, MD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2020

Primary Completion (Actual)

January 19, 2022

Study Completion (Actual)

January 19, 2022

Study Registration Dates

First Submitted

June 22, 2020

First Submitted That Met QC Criteria

June 22, 2020

First Posted (Actual)

June 25, 2020

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019_68
  • 2020-A00738-31 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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