EBUS-guided TBNA for Molecular Diagnostic of Mediastinal Lymph Nodes (LN)
October 5, 2009 updated by: Heidelberg University
EBUS-guided TBNA for Molecular Diagnostic of Mediastinal Lymph Nodes
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).
Study Overview
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.
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michael Kreuter, MD
- Phone Number: 1201 49 / 6221 / 396
- Email: michael.kreuter@thoraxklinik-heidelberg.de
Study Locations
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Heidelberg, Germany, 69126
- Recruiting
- Thoraxklinik Heidelberg, Dept. of Pneumology and Respiratory Critical care
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Contact:
- Michael Kreuter, MD
- Phone Number: 1201 49 / 6221 / 396
- Email: michael.kreuter@thoraxklinik-heidelberg.de
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with operable non-small cell lung cancer
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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non small cell lung cancer
cancer patients
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EBUS during bronchoscopy
Other Names:
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Michael Kreuter, MD, Thoraxklinik Heidelberg, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Herth FJ, Eberhardt R. Actual role of endobronchial ultrasound (EBUS). Eur Radiol. 2007 Jul;17(7):1806-12. doi: 10.1007/s00330-006-0497-6. Epub 2007 Jan 6.
- 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. doi: 10.1183/09031936.06.00124905. Epub 2006 Jun 28.
- 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. doi: 10.1136/thx.2005.047829. Epub 2006 May 31.
- 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. doi: 10.1111/j.1365-2303.2006.00318.x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Anticipated)
October 1, 2010
Study Completion (Anticipated)
January 1, 2011
Study Registration Dates
First Submitted
September 22, 2009
First Submitted That Met QC Criteria
September 22, 2009
First Posted (Estimate)
September 23, 2009
Study Record Updates
Last Update Posted (Estimate)
October 6, 2009
Last Update Submitted That Met QC Criteria
October 5, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MK01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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