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NCT00982605 Clinical Trial

EBUS-guided TBNA for Molecular Diagnostic of Mediastinal Lymph Nodes (LN)

Non Small Cell Lung Cancer Clinical Trial

Official title:
EBUS-guided TBNA for Molecular Diagnostic of Mediastinal Lymph Nodes

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00982605
Other study ID # MK01
Secondary ID
Status Recruiting
Phase N/A
First received September 22, 2009
Last updated October 5, 2009
Start date October 2009
Est. completion date January 2011

Study information
Verified date October 2009
Source Heidelberg University
Contact Michael Kreuter, MD
Phone 49 / 6221 / 396
Email michael.kreuter@thoraxklinik-heidelberg.de
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

The purpose of this study is to perform molecular diagnostic in mediastinal lymph nodes of non-small cell lung cancer patients sampled by endobronchial ultrasound guided finde needle aspiration (EBUS-TBNA).

Description:

NSCLC is a common cancer. Accurate and early staging has a significant impact on outcome. EBUS-TBNA of involved mediastinal lymph nodes is critical. Molecular markers could improve mediastinal staging.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date January 2011
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Age = 18 years

- Samples are collected before surgery or before any therapy

- ECOG 0 or 1

- Clinical stage I-II, T1-2, N0-1, M0)

- Surgically respectable

- Patient with enlarged med. lymphnodes (control group)

Exclusion Criteria:

- Previous RT/CHT

- Previous or current cancer of other entity

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• EBUS_TBNA
EBUS during bronchoscopy

Locations
Country Name City State
Germany Thoraxklinik Heidelberg, Dept. of Pneumology and Respiratory Critical care Heidelberg

Sponsors (1)
Lead Sponsor Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (5)

Al-Haddad M, Wallace MB. Molecular diagnostics of non-small cell lung cancer using mediastinal lymph nodes sampled by endoscopic ultrasound-guided needle aspiration. Cytopathology. 2006 Feb;17(1):3-9. Review. — View Citation

Herth FJ, Annema JT, Eberhardt R, Yasufuku K, Ernst A, Krasnik M, Rintoul RC. Endobronchial ultrasound with transbronchial needle aspiration for restaging the mediastinum in lung cancer. J Clin Oncol. 2008 Jul 10;26(20):3346-50. doi: 10.1200/JCO.2007.14.9229. Epub 2008 Jun 2. — View Citation

Herth FJ, Eberhardt R, Vilmann P, Krasnik M, Ernst A. Real-time endobronchial ultrasound guided transbronchial needle aspiration for sampling mediastinal lymph nodes. Thorax. 2006 Sep;61(9):795-8. Epub 2006 May 31. — View Citation

Herth FJ, Eberhardt R. Actual role of endobronchial ultrasound (EBUS). Eur Radiol. 2007 Jul;17(7):1806-12. Epub 2007 Jan 6. — View Citation

Herth FJ, Ernst A, Eberhardt R, Vilmann P, Dienemann H, Krasnik M. Endobronchial ultrasound-guided transbronchial needle aspiration of lymph nodes in the radiologically normal mediastinum. Eur Respir J. 2006 Nov;28(5):910-4. Epub 2006 Jun 28. — View Citation

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