Clinical Impact of EUS in Staging NSCLC

Indiana University

Status: Completed

Conditions: Non Small Cell Lung

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00577746

IRB # 0306-37

0306-37

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

110 participants in 2 patient groups

surgery

Description:

Those subjects who went to surgery for treatment for their lung cancer.

no surgery

Description:

The subjects who did not go to surgery for treatment of their lung cancer.