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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
  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:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

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.

  Eligibility

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

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

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

Locations
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
Investigators
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:
biopsy
needle aspiration
mutational analysis

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013