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Completed

NCT Number: NCT04447456

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Oscar Lambret, Lille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: VO Qual

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 25, 2020
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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