NCT03116633已完成不适用
An Observational Multicenter Study to Evaluate the Performance and Utility of Inivata Liquid Biopsy Analysis Compared With Tissue Biopsy Analysis for Detection of Genomic Alterations in Patients With Lung Cancer
Inivata6 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2017年6月30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
- 34
- 试验地点
- 6
- 主要终点
- Concordance in the detection of molecular abnormalities using Inivata liquid biopsy panel with detection using standard of care tissue biopsy analysis.
研究概览
简要总结
This study aims to look at a comparison of liquid biopsy (blood sample) analysis compared with tissue biopsy in patients with advanced lung cancer
详细描述
The primary aim of this study is to investigate the concordance of Inivata liquid biopsy panel with standard tissue biopsy analysis for detecting genomic alterations in patients with advanced non-squamous non-small cell lung cancer (NSCLC).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Written, signed and dated informed consent
- •Male & female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC.
- •Patients intended to initiate first-line treatment (Arms A and B)
- •Patients who plan to have or have had a recent tumor tissue biopsy taken as part of their standard of care (Arm A)
- •Patient must understand and be able, willing and likely to fully comply with all study procedures and restrictions.
排除标准
- •Patients who have received any approved or experimental cancer therapy since their most recent NSCLC tissue biopsy
- •Any history of metastatic cancer.
- •Previous malignancy in the last 2 years (except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix).
- •Patient with a severe acute or chronic medical or psychiatric condition or laboratory abnormality
结局指标
主要结局
Concordance in the detection of molecular abnormalities using Inivata liquid biopsy panel with detection using standard of care tissue biopsy analysis.
时间窗: 12 months
The primary endpoint is concordance in detecting molecular abnormalities using Inivata liquid biopsy panel compared with detection using tissue biopsy analysis.
次要结局
- Sensitivity of Inivata liquid biopsy analysis relative to matched tissue analysis(12 months)
- Specificity of Inivata liquid biopsy analysis relative to matched tissue analysis(12 months)
- Description of the ctDNA profile of genomic alterations in patients where tumour tissue is limited versus that observed where tumour biopsy is achieved(12 months)
研究者
研究点 (6)
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