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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01482572
First Posted: November 30, 2011
Last Update Posted: November 20, 2015
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.
Information provided by (Responsible Party):
Samsung Medical Center
  Purpose
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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

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

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

Biospecimen Retention:   Samples With DNA
lung tissue

Enrollment: 0
Study Start Date: January 2012
Study Completion Date: November 2015
Primary Completion Date: November 2015 (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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
lung cancer patients
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01482572


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

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01482572     History of Changes
Other Study ID Numbers: 2011-10-078
First Submitted: November 28, 2011
First Posted: November 30, 2011
Last Update Posted: November 20, 2015
Last Verified: October 2015

Keywords provided by Samsung Medical Center:
biopsy
needle aspiration
mutational analysis

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases