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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Samsung Medical Center.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
First received: November 28, 2011
Last updated: June 7, 2012
Last verified: June 2012

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).

Condition Intervention
Lung Cancer
Procedure: biopsy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Feasibility of Gene Expression Profiling Using Low-volume Lung Aspirate

Further study details as provided by Samsung Medical Center:

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

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

Biospecimen Retention:   Samples With DNA

lung tissue

Estimated Enrollment: 50
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Gene profiling Success Procedure: biopsy
percutaneous lung biopsy and aspiration

Detailed Description:

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


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

lung cancer patients


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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01482572

Contact: Ho Yun Lee, Dr. hoyunlee96@gmail.com

Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Lee       hj0503.lee@samsung.com   
Principal Investigator: Ho Yun Lee         
Sponsors and Collaborators
Samsung Medical Center
Principal Investigator: Ho Yun Lee, Dr. Samsung Medical Center
  More Information

No publications provided

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01482572     History of Changes
Other Study ID Numbers: 2011-10-078
Study First Received: November 28, 2011
Last Updated: June 7, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
needle aspiration
mutational analysis

ClinicalTrials.gov processed this record on August 27, 2015