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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00982605
Recruitment Status : Unknown
Verified October 2009 by Heidelberg University.
Recruitment status was:  Recruiting
First Posted : September 23, 2009
Last Update Posted : October 6, 2009
Information provided by:
Heidelberg University

Brief 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).

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Procedure: EBUS_TBNA

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: EBUS-guided TBNA for Molecular Diagnostic of Mediastinal Lymph Nodes
Study Start Date : October 2009
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
non small cell lung cancer
cancer patients
Procedure: EBUS_TBNA
EBUS during bronchoscopy
Other Name: EBUS-TBNA scope, Olympus Medical

Biospecimen Retention:   Samples With DNA
lymph nodes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with operable non-small cell lung cancer

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00982605

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Contact: Michael Kreuter, MD 49 / 6221 / 396 ext 1201

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Thoraxklinik Heidelberg, Dept. of Pneumology and Respiratory Critical care Recruiting
Heidelberg, Germany, 69126
Contact: Michael Kreuter, MD    49 / 6221 / 396 ext 1201   
Sponsors and Collaborators
Heidelberg University
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Study Director: Michael Kreuter, MD Thoraxklinik Heidelberg, Germany
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Responsible Party: Prof. Felix Herth, Thoraxklinik Heidelberg Identifier: NCT00982605    
Other Study ID Numbers: MK01
First Posted: September 23, 2009    Key Record Dates
Last Update Posted: October 6, 2009
Last Verified: October 2009
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases