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NCT02157194 Clinical Trial

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

Lung Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02157194
Other study ID # RLK-EBUS-2
Secondary ID 11-4921-BO
Status Completed
Phase N/A
First received June 1, 2014
Last updated October 24, 2016
Start date February 2013
Est. completion date May 2015

Study information
Verified date October 2016
Source University Hospital, Essen
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 88
Est. completion date May 2015
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- clinical diagnosis of lung cancer

- enlarged mediastinal or hilar lymph nodes (>10 mm)

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Ruhrlandklinik-UK Essen Essen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity and Specificity of lung cancer diagnosis We aim to evaluate if splitting the obtained specimen will have an impact on lung cancer diagnosis performed by histopathologic analysis 6 month No
Secondary Percentage of successful performed molecular RNA based analysis 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. 3 month No
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