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

Glottic Carcinoma Clinical Trial

— VO Qual  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04447456
• Other study ID #: 2019_68
• Secondary ID: 2020-A00738-31
• Status: Completed
• Start date: November 3, 2020
• Est. completion date: January 19, 2022

Study information

• Verified date: February 2023
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 criterion of voice quality after treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 19, 2022
• Est. primary completion date: January 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Glottic Carcinoma

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille
France	Hôpital Huriez, CHU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 5 years
Secondary	Maximum Phonation Time	The TMP is the measurement in seconds of a vowel (/a/) held for as long as possible.	At 5 years
Secondary	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.	At 5 years
Secondary	Acoustic Analysis by Vocalab software	short recording of the patient's voice delivering a standardized speech on VOCALAB software validated by the scientific community.	At 5 years