Clinical Impact of EUS in Staging NSCLC

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00577746

Enrollment

110

Registered

2007-12-20

Start date

2006-06-30

Completion date

2013-09-30

Last updated

2014-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung

Keywords

Non Small Cell Lung

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Determine the accuracy of EUS in staging NSCLC	at the end of the study

Secondary

Measure	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

Countries

United States

Outcome results