EBUS-guided TBNA for Molecular Diagnostic of Mediastinal... | NCT00982605

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

NCT00982605

Sponsor

Heidelberg University

Status

Unknown status

Last Update Posted

Oct 6, 2009Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Non Small Cell Lung Cancer

Interventions

EBUS_TBNA

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Oct 2010Estimated

Completion Date

Jan 2011Estimated

First Submitted Date

Sep 22, 2009

First Submission Date that Met QC Criteria

Sep 22, 2009

First Posted Date

Sep 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2009

Last Update Posted Date

Oct 6, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
non small cell lung cancer		cancer patients	Procedure: EBUS_TBNA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EBUS_TBNA	Procedure	EBUS during bronchoscopy	non small cell lung cancer

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with operable non-small cell lung cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael Kreuter, MD	Contact	49 / 6221 / 396	1201	michael.kreuter@thoraxklinik-heidelberg.de

Overall Officials

Name	Affiliation	Role
Michael Kreuter, MD	Thoraxklinik Heidelberg, Germany	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thoraxklinik Heidelberg, Dept. of Pneumology and Respiratory Critical care	Recruiting	Heidelberg		69126	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18519953	Background	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.
17206430	Background	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.

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms