EBUS-guided TBNA for Molecular Diagnostic of Mediastinal Lymph Nodes (LN)
1 other identifier
observational
50
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2009
CompletedFirst Posted
Study publicly available on registry
September 23, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedOctober 6, 2009
October 1, 2009
1 year
September 22, 2009
October 5, 2009
Conditions
Study Arms (1)
non small cell lung cancer
cancer patients
Interventions
EBUS during bronchoscopy
Eligibility Criteria
Patients with operable non-small cell lung cancer
You may qualify if:
- 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)
You may not qualify if:
- Previous RT/CHT
- Previous or current cancer of other entity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thoraxklinik Heidelberg, Dept. of Pneumology and Respiratory Critical care
Heidelberg, 69126, Germany
Related Publications (5)
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.
PMID: 18519953BACKGROUNDHerth 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.
PMID: 17206430BACKGROUNDHerth 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.
PMID: 16807262BACKGROUNDHerth 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.
PMID: 16738038BACKGROUNDAl-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.
PMID: 16417559BACKGROUND
Biospecimen
lymph nodes
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael Kreuter, MD
Thoraxklinik Heidelberg, Germany
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 22, 2009
First Posted
September 23, 2009
Study Start
October 1, 2009
Primary Completion
October 1, 2010
Study Completion
January 1, 2011
Last Updated
October 6, 2009
Record last verified: 2009-10