Clinical Impact of EUS in Staging NSCLC

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

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.

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Medical Center; Clarian Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Richard L. Roudebush VA Medical Center
• Investigators: Principal Investigator: Julia LeBlanc, MD, MPH, Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: December 19, 2007
• First Submitted That Met QC Criteria: December 19, 2007
• First Posted (Estimate): December 20, 2007

Study Record Updates

• Last Update Posted (Estimate): September 5, 2014
• Last Update Submitted That Met QC Criteria: September 3, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Non Small Cell Lung
• Other Study ID Numbers: 0306-37; IRB # 0306-37