NCT00578084

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

June 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 20, 2007

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

October 8, 2013

Status Verified

September 1, 2013

Enrollment Period

7.1 years

First QC Date

December 19, 2007

Last Update Submit

October 7, 2013

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clarian/IUPUI: University Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Julia LeBlanc, MD, MPH

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 20, 2007

Study Start

June 1, 2006

Primary Completion

July 1, 2013

Study Completion

September 1, 2013

Last Updated

October 8, 2013

Record last verified: 2013-09

Locations

US(1)