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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01482572
Recruitment Status : Withdrawn
First Posted : November 30, 2011
Last Update Posted : November 20, 2015
Information provided by (Responsible Party):
Samsung Medical Center

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).

Condition or disease Intervention/treatment
Lung Cancer Procedure: biopsy

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

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Feasibility of Gene Expression Profiling Using Low-volume Lung Aspirate
Study Start Date : January 2012
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Lung Cancer

Group/Cohort Intervention/treatment
Gene profiling Success Procedure: biopsy
percutaneous lung biopsy and aspiration

Primary Outcome Measures :
  1. Success rates for mutation analysis [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Technical success rate of biopsy procedure [ Time Frame: one year ]

Biospecimen Retention:   Samples With DNA
lung tissue

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01482572

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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
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Principal Investigator: Ho Yun Lee, Dr. Samsung Medical Center

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Responsible Party: Samsung Medical Center Identifier: NCT01482572     History of Changes
Other Study ID Numbers: 2011-10-078
First Posted: November 30, 2011    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: October 2015
Keywords provided by Samsung Medical Center:
needle aspiration
mutational analysis
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases