跳至主要内容
临床试验/NCT03270670
NCT03270670已完成不适用

A Pilot Study Evaluating the Performance of 19-gauge Needles in Testing Molecular Markers in Samples Obtained Via Endobronchial Ultrasound Guided Needle Aspiration of Lymph Nodes in Patients With Lung Cancer

Duke University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年8月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Molecular marker test

研究概览

简要总结

The purpose of this study is to test whether the 19-gauge needle can collect more tissue and get better sampling during a bronchoscopy procedure.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects with known or suspected lung cancer with mediastinal adenopathy as defined by a mediastinal lymph node >0.5 cm in short axis on EBUS or any lymph node with uptake on FDG-PET scan that is higher than background PET activity.
  • Participants must lack bleeding disorders

排除标准

  • Subjects who lack fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure
  • Subjects with suspected sarcoidosis, lymphoma, or metastatic cancer from other sites (i.e. those without a known or suspected lung primary)
  • Subjects on anticoagulation (other than Aspirin) whom cannot have their anticoagulation held for the procedure due to other clinical reasons (i.e. recent cardiac stent placement).

结局指标

主要结局

Molecular marker test

时间窗: Day of Procedure

Descriptive statistics will be used to calculate the success rate of the procedure in successful performance of molecular marker testing

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验