Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- sensitivity and specificity of serum and salivary CYFRA21-1 as a diagnostic marker in oral cancer
研究概览
简要总结
The study is designed to measure serum and salivary CYFRA21-1 levels using enzyme linked immunosorbent assay (ELISA) in patients with oral malignancy, oral potentially malignant lesions, and control subjects to evaluate the potential of CYFRA21-1 as a diagnostic marker for malignant transformation in potentially malignant oral mucosal lesions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •participants will be divided into 3 groups:
- •Group I: patients suffering from oral potentially malignant lesions (PML) as defined by World Health Organization.
- •Group II: patients suffering from diagnosed oral malignant lesions
- •Group III: healthy subjects who are systemically free, non-smokers, and not suffering from any oral mucosal lesions.
排除标准
- •Subjects taking any drugs inducing any changes that could affect the salivary flow.
- •Pregnant females.
- •Subjects have any allergies, infectious diseases or active dental abscesses during one month before saliva sampling.
- •Patients receiving any drugs related to the oral lesions in the past 6 month prior to sample collection.
结局指标
主要结局
sensitivity and specificity of serum and salivary CYFRA21-1 as a diagnostic marker in oral cancer
时间窗: one year
diagnostic accuracy in terms of sensitivity and specificity of serum and salivary CYFRA21-1 in differentiating between oral malignancy and oral potential malignant lesions in order to be able to early diagnose malignant changes in oral lesions.
次要结局
未报告次要终点
研究者
Salsabeel Ali Mahmoud
PHD postgraduate student
Cairo University