跳至主要内容
临床试验/NCT04919460
NCT04919460Unknown早期 1 期

Research on Optimization and Evaluation of Oral Cancer Screening Methods

Hunan Cancer Hospital0 个研究点目标入组 10,000 人开始时间: 2021年6月最近更新:
适应症

试验速览

阶段
早期 1 期
入组人数
10,000
主要终点
The rate of participants being detected as positive

研究概览

简要总结

An evaluation and validation study on oral cancer screening methods will be carried out, and two different methods will be used for oral cancer screening among the population. The two different methods are: (1) clinical observation (including inspection and palpation) combined with pathological biopsy. (2) Clinical observation (including inspection and palpation), in vivo staining (toluidine blue) combined with pathological biopsy. By evaluating and comparing the sensitivity and specificity of the two screening methods, the more effective oral cancer screening method will be selected.

详细描述

An evaluation and validation study on oral cancer screening methods will be carried out, and two different methods will be used for oral cancer screening among the population. The two different methods are: (1) clinical observation (including inspection and palpation) combined with pathological biopsy. That is, inspecting and palpating the oral cavity and neck of the screened object. If positive lesions are found, then further pathological biopsy will be performed. This is also the commonly used screening method for oral cancer now; (2) Clinical observation (including inspection and palpation), in vivo staining (toluidine blue) combined with pathological biopsy. That is, toluidine blue staining is performed at the same time as the inspection and palpation of the oral cavity and neck of the screening object. As long as the screening subjects found positive lesions or abnormal living body staining, pathological biopsy was performed. By evaluating and comparing the sensitivity and specificity of the two screening methods, the more effective oral cancer screening method will be selected. Finally, we will carry out prospective controlled population studies in high-risk areas and non-high-risk areas to further evaluate the effectiveness and feasibility of screening method after selection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
40 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged 40-69 years old.

排除标准

  • 未提供

结局指标

主要结局

The rate of participants being detected as positive

时间窗: 1 year

Among all participants, the rate of being tested positive by two methods

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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