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Lung Cancer Location: a Repository

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ClinicalTrials.gov Identifier: NCT00578084
Recruitment Status : Terminated
First Posted : December 20, 2007
Last Update Posted : October 8, 2013
Sponsor:
Information provided by (Responsible Party):
Indiana University

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Lung Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lung Cancer Location: A Prospective Repository
Study Start Date : June 2006
Actual Primary Completion Date : July 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 [ Time Frame: ongoing-database ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00578084


Locations
United States, Indiana
Clarian/IUPUI: University Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Julia LeBlanc, MD, MPH Indiana University
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00578084     History of Changes
Other Study ID Numbers: 0604-76
IRB # 0604-76
First Posted: December 20, 2007    Key Record Dates
Last Update Posted: October 8, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases