Detection of Heterogeneity in Central Lung Cancer - Prospective Randomized Controlled Trial to Evaluate the Diagnostic Value of EBUS-TBNA and ctDNA Analysis Compared to Endobronchial Forceps Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of detected mutations
研究概览
简要总结
Study participants will be selected from clinical routine patients with endobronchial infiltration of a central lung cancer and indication for bronchoscopic sampling.
Consented patients will undergo bronchoscopy for tumor sampling applying two routine sampling methods during one single procedure (EBUS-TBNA and conventional forceps sampling). The sequence of both sampling methods will be randomized in advance.
The resulting tissue samples will be analyzed by a pathologist using multiplex PCR and FISH. The corresponding analysis results will be compared between sampling methods.
Assignment of a subject to a particular therapeutic strategy is not influenced by this protocol. Medicinal products will be used according to current practice and marketing authorisation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects eligible for enrolment in the study must meet all of the following criteria:
- •Informed consent: a signed and dated written informed consent prior to study participation.
- •Type of subject: inpatient
- •Age: subjects of more than 18 years and less than 85 years.
- •Central lesion in computed tomography highly suspicious of lung cancer with clinical indication for further diagnostic applying bronchoscopy.
- •Central lesion has to be accessible by the biopsy techniques under investigation
排除标准
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •Females who are pregnant or lactating , who decide not to undergo a bronchoscopy due to the risk for their child
- •Any contraindication for bronchoscopy and EBUS-TBNA (IBNLT: INR>2, thrombocytopenia <40/nl)
- •Drug/alcohol abuse impairing cognitive knowledge which is needed for a GCP conform informed consent.
- •Inability to read or inability of language: in the opinion of the investigator, any subject who is unable to read and/or would not be able to complete study related materials.
研究组 & 干预措施
EBUS-TBNA - Endobrochial Forceps Biopsy
In this arm, EBUS-TBNA will be done first, followed by endobronchial forceps biopsy
干预措施: EBUS-TBNA (Procedure)
EBUS-TBNA - Endobrochial Forceps Biopsy
In this arm, EBUS-TBNA will be done first, followed by endobronchial forceps biopsy
干预措施: Endobronchial forceps biopsy (Procedure)
Forceps - EBUS-TBNA
In this arm, endobronchial forceps biopsy will be done first, followed by EBUS-TBNA
干预措施: EBUS-TBNA (Procedure)
Forceps - EBUS-TBNA
In this arm, endobronchial forceps biopsy will be done first, followed by EBUS-TBNA
干预措施: Endobronchial forceps biopsy (Procedure)
结局指标
主要结局
Number of detected mutations
时间窗: within 7 days after biopsy
The number of different mutations detected based on each biopsy method as well as ctDNA analysis is determined
次要结局
未报告次要终点