NCT04447456已完成不适用
Comparison of Voice Results at 5 Years of Treatment of Glottic Squamous Cell Carcinoma T1 by Surgery Versus Radiotherapy
University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2020年11月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Voice Handicap Index
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Tis, T1a and T1b glottic squamous cell carcinomas according to the TNM 7th edition classification in long-term survivors.
排除标准
- 未提供
研究组 & 干预措施
Surgery
Radiotherapy
结局指标
主要结局
Voice Handicap Index
时间窗: 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.
次要结局
- Maximum Phonation Time(At 5 years)
- Grade, Roughness, Breathiness, Asthenia, Strain, Instability SCORE (GRBASI Score)(At 5 years)
- Acoustic Analysis by Vocalab software(At 5 years)
研究者
研究点 (2)
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