NCT05400018已完成不适用
Clinical Evaluation of Genetron D842V PCR Kit in GIST Patients
Genetron Health3 个研究点 分布在 1 个国家目标入组 1,041 人开始时间: 2020年11月20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
- 1,041
- 试验地点
- 3
- 主要终点
- Ct Value (Ct Values From PCR Reaction)
研究概览
简要总结
The purpose of this trail is to evaluate the performance of Genetron D842V PCR kit in GIST 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 D842V PCR Kit and Sanger sequencing method. The results were determined independently according to the cutoff values or interpretation requirements provided by each method. The safety and effectiveness of this kit are confirmed and evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paraffin-embedded tissue samples from patients clinically diagnosed with gastrointestinal stromal tumor (GIST), and a small number of other cancers or benign lesions in the gastrointestinal site were included as interference samples.
- •The sample should have corresponding basic clinical information, including: the patient's unique traceability number, age, gender, pathological diagnosis results, etc.
- •The sample is a formalin-fixed paraffin-embedded gastrointestinal stromal tumor tissue sample, and each sample can provide 5 paraffin sections or 5 paraffin rolls with a thickness of at least 5 µm.
- •The content of tumor cells meets the requirements of assessment reagents and comparison methods.
排除标准
- •The investigator considers that it is not appropriate to continue the clinical trial, such as the samples that are not prepared according to the required steps.
- •Samples that cannot complete the entire testing process.
- •Patients with incomplete sample information.
结局指标
主要结局
Ct Value (Ct Values From PCR Reaction)
时间窗: 3 months
the number of PCR cycles where the amplification signal starts to be observed
次要结局
- PPV(3 months)
- Consistency (the Overall Ratio of True Positive and True Negative)(3 months)
- Kappa coefficient(3 months)
- NPV(3 months)
研究者
研究点 (3)
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