NCT01482572

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 20, 2015

Status Verified

October 1, 2015

Enrollment Period

3.8 years

First QC Date

November 28, 2011

Last Update Submit

November 17, 2015

Conditions

Lung Cancer

Keywords

biopsyneedle aspirationmutational analysis

Outcome Measures

Primary Outcomes (1)

  • Success rates for mutation analysis

    one year

Secondary Outcomes (1)

  • Technical success rate of biopsy procedure

    one year

Study Arms (1)

Gene profiling Success

Procedure: biopsy

Interventions

biopsyPROCEDURE

percutaneous lung biopsy and aspiration

Gene profiling Success

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

lung cancer patients

You may qualify if:

  • primary tumor or a metastatic lung lesion requested for mutational analysis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

lung tissue

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Ho Yun Lee, Dr.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2011

First Posted

November 30, 2011

Study Start

January 1, 2012

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

November 20, 2015

Record last verified: 2015-10

Locations

KR(1)