Feasibility of Mutational Analysis of Non-Small Cell Lung Cancer (NSCLC) Using Low-volume Lung Aspirates

This study is currently recruiting participants.

Verified June 2012 by Samsung Medical Center

Sponsor:

Information provided by (Responsible Party):

Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT01482572

First received: November 28, 2011

Last updated: June 7, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 28, 2011

Last Updated Date

June 7, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Success rates for mutation analysis [ Time Frame: one year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01482572 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Technical success rate of biopsy procedure [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Feasibility of Mutational Analysis of Non-Small Cell Lung Cancer (NSCLC) Using Low-volume Lung Aspirates

Official Title ^ICMJE

Feasibility of Gene Expression Profiling Using Low-volume Lung Aspirate

Brief Summary

The purpose of this study is to evaluate the feasibility of aspiration samples for mutational analysis in patients with a non-small cell lung cancer (NSCLC).

Detailed Description

The investigators will compare results of mutational analysis from a core needle biopsy and fine needle aspiration.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

lung tissue

Sampling Method

Non-Probability Sample

Study Population

lung cancer patients

Condition ^ICMJE

Lung Cancer

Intervention ^ICMJE

Procedure: biopsy

percutaneous lung biopsy and aspiration

Study Group/Cohort (s)

Gene profiling Success

Intervention: Procedure: biopsy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2014

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

primary tumor or a metastatic lung lesion requested for mutational analysis

Exclusion Criteria:

a) lesions located adjacent to the large central bronchi or vessels
b) peribronchovascular lesions with prominent internal CT air-bronchograms, which were considered difficult to be avoided by needle pass
c) lesions in patient with severe respiratory compromise

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ho Yun Lee, Dr.

hoyunlee96@gmail.com

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01482572

Other Study ID Numbers ^ICMJE

2011-10-078

Has Data Monitoring Committee

Yes

Responsible Party

Samsung Medical Center

Study Sponsor ^ICMJE

Samsung Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ho Yun Lee, Dr.

Samsung Medical Center

Information Provided By

Samsung Medical Center

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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