- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01482572
Feasibility of Mutational Analysis of Non-Small Cell Lung Cancer (NSCLC) Using Low-volume Lung Aspirates
November 17, 2015 updated by: Samsung Medical Center
Feasibility of Gene Expression Profiling Using Low-volume Lung Aspirate
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).
Study Overview
Detailed Description
The investigators will compare results of mutational analysis from a core needle biopsy and fine needle aspiration.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of
- Samsung Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
lung cancer patients
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Gene profiling Success
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percutaneous lung biopsy and aspiration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Success rates for mutation analysis
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Technical success rate of biopsy procedure
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ho Yun Lee, Dr., Samsung Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
November 28, 2011
First Submitted That Met QC Criteria
November 29, 2011
First Posted (Estimate)
November 30, 2011
Study Record Updates
Last Update Posted (Estimate)
November 20, 2015
Last Update Submitted That Met QC Criteria
November 17, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-10-078
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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