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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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 ] [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014