Endobronchial Ultrasound-transbronchial Needle Aspiration (EBUS-TBNA) Sample Division

Completed

• Conditions: Lung Cancer

• Registration Number: NCT02157194
• Lead Sponsor: University Hospital, Essen

Brief Summary

EBUS-TBNA specimen are used for lung cancer diagnosing and staging, as well for molecular analysis. The purpose of this study is to evaluate if samples from on lymph node site can be divided for diagnosis and molecular analysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2014-03
• Study First Submitted: 2014-06-01
• Study First Submitted QC: 2014-06-03
• Study First Posted: 2014-06-05
• Study Completion: 2015-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• clinical diagnosis of lung cancer
• enlarged mediastinal or hilar lymph nodes (>10 mm)

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of lung cancer diagnosis	6 month	We aim to evaluate if splitting the obtained specimen will have an impact on lung cancer diagnosis performed by histopathologic analysis

Secondary Outcome Measures

Name	Time	Method
Percentage of successful performed molecular RNA based analysis	3 month	We will analyse the second half of the sample regarding molecular analysis. RNA concentration and RNA integrity score will be assessed before a new RNA based test will be evaluated.

Trial Locations

Locations (1)

Ruhrlandklinik-UK Essen; 🇩🇪 Essen, Germany