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

Lung Cancer Clinical Trial

Official title:

Feasibility of Gene Expression Profiling Using Low-volume Lung Aspirate

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01482572
• Other study ID #: 2011-10-078
• Status: Withdrawn
• Phase: N/A
• First received: November 28, 2011
• Last updated: November 17, 2015
• Start date: January 2012
• Est. completion date: November 2015

Study information

• Verified date: October 2015
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Procedure:
• biopsy
percutaneous lung biopsy and aspiration

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rates for mutation analysis		one year	No
Secondary	Technical success rate of biopsy procedure		one year	Yes