Clinical Evaluation of Genetron IDH1 PCR Kit in Glioma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,192
- 试验地点
- 4
- 主要终点
- Efficacy of the Genetron IDH1 PCR Kit
研究概览
简要总结
The purpose of this trail is to evaluate the performance of Genetron IDH1 PCR Kit in Glioma patients using real-time PCR method.
详细描述
This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron IDH1 PCR Kit and Sanger sequencing method. The results were determined independently according to the cutoff values or interpretation requirements provided by each method. Combined with the results of clinicopathological classification, the incidence of IDH1 gene R132H mutation in different subtypes was counted to evaluate the clinical performance of the Genetron IDH1 PCR Kit.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enroll cases in strict accordance with the requirements of the study
- •The remaining samples after routine clinical testing
- •The collection and processing of samples meet the requirements of standard laboratory operations and product instructions
- •The relevant information of the sample is complete, including sample number, gender, age, and possible clinical diagnosis information
- •Each sample must have HE staining results (hematoxylin-eosin staining)
- •Pathological examination diagnosed as glioma, other brain tumors or normal tissues
- •Number of samples: 10 pieces of each sample with a thickness of 10μm, and the tumor content is not less than 50%
排除标准
- •Incomplete sample information
- •Severely contaminated samples
- •Samples that do not meet the requirements of sample collection and processing
结局指标
主要结局
Efficacy of the Genetron IDH1 PCR Kit
时间窗: 3 months
The main purpose of this study is: by evaluating the Genetron IDH1 PCR Kit to compare the results of the Sanger sequencing method, and to calculate the coincidence rate and consistency of the two methods.
次要结局
未报告次要终点