Lung Cancer Location: a Repository | NCT00578084

Studies
Lung Cancer Location: a Repository

NCT00578084

Sponsor

Indiana University

Status

Terminated

Last Update Posted

Oct 8, 2013Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Lung Cancer

Interventions

Not provided

Countries

United States

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

ID	Type	Description	Link
IRB # 0604-76

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Jul 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Dec 19, 2007

First Submission Date that Met QC Criteria

Dec 19, 2007

First Posted Date

Dec 20, 2007Estimated

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

Oct 7, 2013

Last Update Posted Date

Oct 8, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 repository is to prospectively examine subjects with known or suspected lung cancer to determine the extent of mediastinal lymph node involvement with respect to primary lung cancer location. The data collected in this repository may be used to influence our current standard of care and streamline indications for EUS.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
surgery		those subjects who went to surgery to treat their lung cancer
no surgery		those subjects who did not go to surgery for their lung cancer
NSCLC		subjects with NSCLC
Small cell lung cancer		those with small cell lung cancer

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
examine subjects with known or suspected lung cancer to determine the extent of mediastinal lymph node involvement with respect to primary lung cancer location		ongoing-database

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects undergoing EUS evaluation of a mediastinal mass, or suspected/known lung cancer
Subjects with a prior history of lung cancer
Subjects referred to thoracic surgery for evaluation of a suspected/known lung cancer

Exclusion Criteria:

Altered mental status that would prohibit the giving and understanding of informed consent
Dementia
Psychiatric illness that would preclude adequate compliance with communication for this protocol
Prisoners

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects with known or suspected lung cancer will be identified by referral to the thoracic surgeon or ultrasonographer at the Veterans Affairs Hospital or Indiana University Medical Center.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julia LeBlanc, MD, MPH	Indiana University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clarian/IUPUI: University Hospital		Indianapolis	Indiana	46202	United States

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