NCT05049408已完成不适用
Verification of Saliva MMP-1 as a Strong Diagnostic Marker of Oral Cavity Cancer
S&T Biomed Co., Ltd.2 个研究点 分布在 1 个国家目标入组 1,160 人开始时间: 2011年2月17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
- 1,160
- 试验地点
- 2
- 主要终点
- Sensitivity and Specificity (both range from 0 to 1, the higher the better) of salivary MMP-1 levels as a diagnostic marker for OSCC
研究概览
简要总结
The study is designed to measure salivary matrix metalloproteinase-1 (MMP-1) using the enzyme-linked immunosorbent assay (ELISA) we developed previously in patients with oral potentially malignant disorders (OPMD), oral squamous cell carcinoma (OSCC), and healthy participants. The purpose of this study is to evaluate the potential of the newly developed salivary MMP-1 ELISA as an adjunctive tool to aid in diagnosis of OSCC.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group OSCC: patients with lesions of OSCC
- •Group OPMD: patients with lesions of OPMD
- •Group HC: healthy subjects who are not suffering from any oral lesions and having behaviors of smoking, and/or betel nut chewing
排除标准
- •Subjects having personal history of other cancers or severe diseases
结局指标
主要结局
Sensitivity and Specificity (both range from 0 to 1, the higher the better) of salivary MMP-1 levels as a diagnostic marker for OSCC
时间窗: 30 days from initial sample obtained for this study
次要结局
- ROC analysis of non-cancer group versus OSCC patients to find the optimal cutoff as the maximum of Youden's index (calculated as sensitivity + specificity - 1 and ranges from 0 to 1, the higher the better)(30 days from initial sample obtained for this study)
研究者
研究点 (2)
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