NCT02726633Unknown不适用
Evaluate the Utility of the ProLung China Test as Adjunctive to CT Scan in the Diagnosis of Lung Cancer
Chinese Alliance Against Lung Cancer3 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2015年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Safety and Efficacy of the ProLung China Test
研究概览
简要总结
A Study to evaluate the utility of the ProLung China Test as an adjunct to CT scan in the diagnosis of lung cancer.
详细描述
This Study will assess the stability of the ProLung China Test classification algorithm when used as an adjunct to CT scan. This Study will assess whether there are any potential safety concerns of the ProLung China Test when used to evaluate patients with a positive CT scan for lung cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is male or female, age 18 to
- •Subject has undergone CT scan of the lung(s) that indicates one or more nodules or lesions.
- •Subject's pulmonary nodule or lesion is greater than 4mm and smaller than 50mm. Size is determined by the largest nodule or lesion dimension identified from CT imaging.
- •Subject must be able to receive a ProLung China Test within 30 days of abnormal CT within 14 days prior to the tissue biopsy or surgical resection.
排除标准
- •Subject has an implanted electronic device in the chest. Subject receiving therapy for suspected chest infection such as fungal infection or tuberculosis.
- •Subject with diagnosed malignancy other than lung cancer who has 2 or more suspicious pulmonary nodules.
- •Subject has received an invasive medical or surgical procedure within the thoracic cavity within 30 days prior to the ProLung China Test or within the previous 14 days for a bronchoscopic procedure.
- •Subject presents with an anomalous physical or anatomical condition that precludes ProLung China Test measurement.
- •Subject will have undergone unusually strenuous exercise within 24 hours.
- •Subject who has significant systemic diseases such as uncontrolled diabetes, advanced heart failure, or a recent myocardial infarction, or other medical condition such as severe morbid obesity that in the judgment of the Principal Investigator would make him/her unsuitable for the Study.
结局指标
主要结局
Safety and Efficacy of the ProLung China Test
时间窗: The ProLung China Test will be performed within 30 days of a CT Scan that identifies a lung lesion suspicious for lung cancer and evaluated once a patient diagnosis is obtained.
Demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer.
次要结局
未报告次要终点
研究者
Bai Chunxue
Chair
Chinese Alliance Against Lung Cancer
研究点 (3)
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