Feasibility of Mutational Analysis of Non-Small Cell Lung... | NCT01482572

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

NCT01482572

Sponsor

Samsung Medical Center

Status

Withdrawn

Last Update Posted

Nov 20, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Lung Cancer

Interventions

biopsy

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Nov 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Nov 28, 2011

First Submission Date that Met QC Criteria

Nov 29, 2011

First Posted Date

Nov 30, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2015

Last Update Posted Date

Nov 20, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gene profiling Success			Procedure: biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biopsy	Procedure	percutaneous lung biopsy and aspiration	Gene profiling Success

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success rates for mutation analysis		one year

Secondary Outcomes

Measure	Description	Time Frame
Technical success rate of biopsy procedure		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

lung cancer patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ho Yun Lee, Dr.	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001706	Biopsy

Ancestor Terms

ID	Term
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided