Clinical Impact of EUS in Staging NSCLC

Study Overview
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Brief Summary
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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.

Official Title
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The Clinical Impact of Endoscopic Ultrasound (EUS) in Staging Non-small Cell Lung Cancer (NSCLC)

Conditions
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Non Small Cell Lung

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| surgery<br>Those subjects who went to surgery for treatment for their lung cancer. | |
| no surgery<br>The subjects who did not go to surgery for treatment of their lung cancer. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the accuracy of EUS in staging NSCLC |  | at the end of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure 5-year survival |  | 5 years | 
| Determine the cost benefit of EUS in staging NSCLC |  | at the end of the study | 
| Measure quality of life in patients that undergo surgery |  | at the end of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non Small Cell Lung