Clinical Impact of EUS in Staging NSCLC

Sponsor

Indiana University (Other)

Overall Status

Completed

CT.gov ID

NCT00577746

Collaborator

Richard L. Roudebush VA Medical Center (U.S. Fed)

110

Enrollment

Location

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung

Study Design

Study Type:

Observational

Actual Enrollment :

110 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Determine the accuracy of EUS in staging NSCLC [at the end of the study]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Medical Center; Clarian Health	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

Indiana University
Richard L. Roudebush VA Medical Center

Investigators

Principal Investigator: Julia LeBlanc, MD, MPH, Indiana University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Indiana University

ClinicalTrials.gov Identifier:

NCT00577746

Other Study ID Numbers:

0306-37
IRB # 0306-37

First Posted:

Dec 20, 2007

Last Update Posted:

Sep 5, 2014

Last Verified:

Sep 1, 2014

Keywords provided by Indiana University

Non Small Cell Lung

Study Results

No Results Posted as of Sep 5, 2014