Glottic CarcinomaVO QualNCT04447456
Comparison of Voice Results at 5 Years of Treatment of Glottic Squamous Cell Carcinoma T1 by Surgery Versus Radiotherapy
An observational study of Glottic Carcinoma, run by University Hospital, Lille at 2 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glottic Carcinoma
- How many people
- 41 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Nov 2020to 19 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients treated for glottic squamous cell carcinoma at Lille University Hospital and the Oscar Lambret Centre between 2015 and 2017.
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
About this study
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.
- Conditions
- Glottic Carcinoma
- Keywords
- Glottic Squamous Cell Carcinoma, Surgery, Radiotherapy, Voice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Not described | |
| Radiotherapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voice Handicap Index
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.
Measured: At 5 years
Secondary outcomes (3)
Maximum Phonation Time
The TMP is the measurement in seconds of a vowel (/a/) held for as long as possible.
Measured: At 5 years
Grade, Roughness, Breathiness, Asthenia, Strain, Instability SCORE (GRBASI Score)
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.
Measured: At 5 years
Acoustic Analysis by Vocalab software
short recording of the patient's voice delivering a standardized speech on VOCALAB software validated by the scientific community.
Measured: At 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start3 Nov 2020
- Primary completion19 Jan 2022
- Study completion19 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glottic CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Mouawad, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447456
- Sponsor's protocol ID
- 2019_68
- Other IDs
- 2020-A00738-31
- Acronym
- VO Qual
- Status last verified
- Feb 2023
- First submitted
- 22 Jun 2020
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Louison J, Labreuche J, Liem X, Rysman B, Morisse M, Mortuaire G, Mouawad F. Voice quality after surgery or radiotherapy for glottic T1 squamous cell carcinoma: Results of the VOQUAL study. Cancer Radiother. 2024 Aug;28(4):373-379. doi: 10.1016/j.canrad.2024.03.004. Epub 2024 Aug 9.
PubMed 39122636
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Voice Results at 5 Years of Treatment of Glottic Squamous Cell Carcinoma T1 by Surgery Versus Radiotherapy
- ClinicalTrials.gov ID
- NCT04447456
- Acronym / sponsor ID
- VO Qual / 2019_68
- Conditions
- Glottic Carcinoma
- Keywords
- Glottic Squamous Cell Carcinoma, Surgery, Radiotherapy, Voice
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 19 Jan 2022 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | – | – |
| Radiotherapy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated for glottic squamous cell carcinoma at Lille University Hospital and the Oscar Lambret Centre between 2015 and 2017.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Maximum Phonation Time
Time frame: At 5 years
Grade, Roughness, Breathiness, Asthenia, Strain, Instability SCORE (GRBASI Score)
Time frame: At 5 years
Acoustic Analysis by Vocalab software
Time frame: At 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Results publication: PubMed 39122636Louison J, Labreuche J, Liem X, Rysman B, Morisse M, Mortuaire G, Mouawad F. Voice quality after surgery or radiotherapy for glottic T1 squamous cell carcinoma: Results of the VOQUAL study. Cancer Radiother. 2024 Aug;28(4):373-379. doi: 10.1016/j.canrad.2024.03.004. Epub 2024 Aug 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Mouawad, MD principal investigator
University Hospital, Lille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glottic Carcinoma, run by University Hospital, Lille at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voice Handicap Index (time frame: At 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04447456, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.