Establishing a Diagnosis of Lung Cancer Through a Fluid Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Clinical diagnosis of lung cancer
研究概览
简要总结
This trial collects and studies blood samples via fluid biopsy for the diagnosis of lung cancer. Studying blood samples in the laboratory may help doctors develop a blood test for lung cancer in the future and provide a better way to screen patients for lung cancer.
详细描述
PRIMARY OBJECTIVE:
I. To estimate the sensitivity and specificity of the fluid biopsy in establishing a diagnosis of bronchogenic carcinoma.
SECONDARY OBJECTIVES:
I. To determine the accuracy of determination of the histologic subtype of bronchogenic lung cancer.
II. To determine the relative contribution of cell based high definition circulating tumor cell assay (HD-CTC) and imaging mass cytometry (IMC) and plasma based circulating tumor deoxyribonucleic acid (ctDNA) assays in determination of diagnosis and histologic subtype.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo a diagnostic biopsy for possible lung cancer or
- •Completed a diagnostic lung cancer biopsy in the prior 2 weeks and has not yet undergone treatment or
- •Planning or completed in the last 2 weeks a CT lung cancer screen
- •Ability to understand and the willingness to sign a written informed consent
排除标准
- •Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
- •Known other solid tumor malignancy other than lung cancer requiring ongoing active treatment
结局指标
主要结局
Clinical diagnosis of lung cancer
时间窗: Within 90 days of tissue biopsy
Descriptive statistics including sensitivity, specificity, positive, and negative predictive value will be tabulated.
次要结局
未报告次要终点