Comparing the Test Characteristics of Three Oral Cancer Screening Techniques:1)Unaided Visual Examination 2)VelScope Examination and 3)Toluidine Blue Application, by Trained Primary Health Care Workers in Mumbai, India.
试验速览
- 阶段
- 3 期
- 入组人数
- 329
- 试验地点
- 2
- 主要终点
- To evaluate the feasibility and efficacy of performance of the three oral cancer screening tests viz. naked eye unaided examination , examination using VELScope and after application of Toluidine Blue by trained primary health workers.
研究概览
简要总结
A feasibility study to compare the test characteristics of three different oral cancer screening techniques performed by trained primary health care workers:1)Unaided Visual Inspection, 2)VelScope Assisted Examination, and 3) Examination after application of Toluidine Blue dye.
详细描述
Oral cancer is the most common cancer among men in India mainly due to the habit of using smokeless tobacco. Pre-cancerous lesions like leukoplakia, melanoplakia, erythroplakia,oral submucous fibrosis and indolent ulcers can be easily detected by periodic examination of the oral cavity of the at-risk populations. Several methods of oral cancer screening have been tried over the past three-four decades with varying success. This study investigates the feasibility of application and compares the test characteristics of three oral cancer screening techniques: Unaided Visual Inspection, VelScope assisted examination and examination after application of Toluidine blue dye by primary health care workers among tobacco users attending a cancer early detection clinic, in Mumbai, India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •The study participants will be apparently healthy males with tobacco habit ( present tobacco users and those who have quit within past six months),
- •above 18 years of age,
- •attending Preventive Oncology clinic.
排除标准
- •Participants with frank oral cancers will not be recruited in the study.
结局指标
主要结局
To evaluate the feasibility and efficacy of performance of the three oral cancer screening tests viz. naked eye unaided examination , examination using VELScope and after application of Toluidine Blue by trained primary health workers.
时间窗: six months
次要结局
- To estimate the test characteristics of each of the three oral cancer screening techniques.(Six months)