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

NCT ID: NCT00982605

Last Updated: 2009-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-01-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Non Small Cell Lung Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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non small cell lung cancer

cancer patients

EBUS_TBNA

Intervention Type PROCEDURE

EBUS during bronchoscopy

Interventions

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EBUS_TBNA

EBUS during bronchoscopy

Intervention Type PROCEDURE

Other Intervention Names

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EBUS-TBNA scope, Olympus Medical

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Thoraxklinik Heidelberg

Principal Investigators

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Michael Kreuter, MD

Role: STUDY_DIRECTOR

Thoraxklinik Heidelberg, Germany

Locations

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Thoraxklinik Heidelberg, Dept. of Pneumology and Respiratory Critical care

Heidelberg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Michael Kreuter, MD

Role: CONTACT

49 / 6221 / 396 ext. 1201

Facility Contacts

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Michael Kreuter, MD

Role: primary

49 / 6221 / 396 ext. 1201

References

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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.

Reference Type BACKGROUND
PMID: 18519953 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17206430 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16807262 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16738038 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16417559 (View on PubMed)

Other Identifiers

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MK01

Identifier Type: -

Identifier Source: org_study_id

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