Clinical Impact of EUS in Staging NSCLC

Completed

• Conditions: Non Small Cell Lung

• Registration Number: NCT00577746
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-20
• Primary Completion: 2013-07
• Study Completion: 2013-09
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-03
• Last Update Posted: 2014-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the accuracy of EUS in staging NSCLC	at the end of the study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Indiana University Medical Center; Clarian Health; 🇺🇸 Indianapolis, Indiana, United States