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

November 28, 2011
June 7, 2012
January 2012
December 2014   (final data collection date for primary outcome measure)
Success rates for mutation analysis [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01482572 on ClinicalTrials.gov Archive Site
Technical success rate of biopsy procedure [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Feasibility of Mutational Analysis of Non-Small Cell Lung Cancer (NSCLC) Using Low-volume Lung Aspirates
Feasibility of Gene Expression Profiling Using Low-volume Lung Aspirate

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).

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

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

lung tissue

Non-Probability Sample

lung cancer patients

Lung Cancer
Procedure: biopsy
percutaneous lung biopsy and aspiration
Gene profiling Success
Intervention: Procedure: biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact: Ho Yun Lee, Dr. hoyunlee96@gmail.com
Korea, Republic of
 
NCT01482572
2011-10-078
Yes
Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Ho Yun Lee, Dr. Samsung Medical Center
Samsung Medical Center
June 2012

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