NCT03790735Unknown不适用
Targeted Chromosomal Aberrations Detection by FISH Analysis of Circulating Abnormal Cells to Differentiate of Benign and Malignant Pulmonary Nodules
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年5月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Early detection of lung cancer
研究概览
简要总结
- The purpose of the study is the identification of the efficacy of MDA Test to Differentiate of Benign and Malignant Pulmonary Nodules.
- In this study, the investigators are going to validate the efficacy of the MDA test for diagnosing early lung cancer by comparing results of the pre-surgery MDA test with the post-surgery pathology.
详细描述
- Current state-of-the-art lung cancer early screening utilizes low-dose CT scan to identify lung nodules smaller than 3 cm in diameter. However, it's still a clinical challenge to differentiate between malignant and benign nodules.
- This study is being conducted to evaluate the efficacy of the MDA TEST to detect Targeted chromosomal aberrations in circulating abnormal cells by FISH analysis that might be an early indicator of lung cancer. Approximately 200 Pre-surgery adult patients with single pulmonary nodule found by CT scan, will be enrolled in the study. The sample type of MDA test is Peripheral Blood. This study will compare the results of the pre-surgery MDA Test with the post-surgery pathology to determine if the test can detect lung cancer or the lack of lung cancer .
- The results of the test will not be provided to the subject, the investigator and will not be used to diagnose or treat the subject.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years old or above
- •single pulmonary nodule found by CT scan.
- •the diameter of the pulmonary nodule is between 5mm to 30mm.
- •plan to accept pneumonectomy due to the pulmonary nodule.
- •agree to sign informed consent
排除标准
- •fail to understand or agree to sign informed consent.
- •pregnant or lactating women.
- •the diameter of the pulmonary nodule is more than 30mm.
- •there are 2 or more pulmonary nodules in one single patient.
结局指标
主要结局
Early detection of lung cancer
时间窗: 6 months
The efficacy of the MDA TEST assay comparing with pathologic diagnosis(the gold standard), and CT/LDCT diagnosis, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).
次要结局
未报告次要终点
研究者
研究点 (1)
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