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Clinical Impact of EUS in Staging NSCLC

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ClinicalTrials.gov Identifier: NCT00577746
Recruitment Status : Completed
First Posted : December 20, 2007
Last Update Posted : September 5, 2014
Sponsor:
Collaborator:
Richard L. Roudebush VA Medical Center
Information provided by (Responsible Party):
Indiana University

Brief Summary:
The goal of this prospective study is to determine the clinical and economic impact of endoscopic ultrasound (EUS) in staging NSCLC. Aims: 1) Determine the accuracy of EUS in staging NSCLC 2) Measure 5-year survival 3) Measure quality of life in patients that undergo surgery 4) Determine the cost benefit of EUS in staging NSCLC.

Condition or disease
Non Small Cell Lung

Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Clinical Impact of Endoscopic Ultrasound (EUS) in Staging Non-small Cell Lung Cancer (NSCLC)
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

U.S. FDA Resources

Group/Cohort
surgery
Those subjects who went to surgery for treatment for their lung cancer.
no surgery
The subjects who did not go to surgery for treatment of their lung cancer.



Primary Outcome Measures :
  1. Determine the accuracy of EUS in staging NSCLC [ Time Frame: at the end of the study ]

Secondary Outcome Measures :
  1. Measure 5-year survival [ Time Frame: 5 years ]
  2. Determine the cost benefit of EUS in staging NSCLC [ Time Frame: at the end of the study ]
  3. Measure quality of life in patients that undergo surgery [ Time Frame: at the end of the study ]


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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
Potentially resectable lung cancer subjects see at thoracic oncology clinics and gastroenterolgy lab.
Criteria

Inclusion Criteria:

  • Any subject with presumed or known potentially resectable NSCLC
  • Due to the nature of NSCLC, children (<18 year of age) will not be considered
  • Men, women, and minorities
  • Subjects must be able to safely undergo conscious sedation for the EUS procedure
  • Subjects must be surgical candidates
  • Subjects must not have an uncorrectable coagulopathy and must be able to refrain from the used of aspirin one week prior to the EUS
  • Patient must provide signed written informed consent

Exclusion Criteria:

  • Subjects with a history of previously treated lung, head & neck, or esophageal cancer are not eligible if the histologic cell type is determined to be the same as what is biopsied during the EUS-FNA
  • Uncorrectable coagulopathy
  • Significant co-morbidities such as uncontrolled heart failure, or severe chronic obstructive pulmonary disease (COPD) that would limit their survivability to surgery
  • Evidence of significant active infection (e.g. pneumonia, peritonitis, wound abscess)
  • Evidence of serious ongoing illness such as uncontrolled metabolic disease (diabetes mellitus, hypothyroidism, etc.) or cardiac condition
  • Evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric illness that would preclude adequate compliance with this protocol

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): NCT00577746


Locations
United States, Indiana
Indiana University Medical Center; Clarian Health
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Richard L. Roudebush VA Medical Center
Investigators
Principal Investigator: Julia LeBlanc, MD, MPH Indiana University School of Medicine

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00577746     History of Changes
Other Study ID Numbers: 0306-37
IRB # 0306-37
First Posted: December 20, 2007    Key Record Dates
Last Update Posted: September 5, 2014
Last Verified: September 2014

Keywords provided by Indiana University:
Non Small Cell Lung