Clinical Impact of EUS in Staging NSCLC

September 3, 2014 updated by: Indiana University

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

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 Time Frame: at the end of the study	at the end of the study

Secondary Outcome Measures

Outcome Measure	Time Frame
Measure 5-year survival Time Frame: 5 years	5 years
Determine the cost benefit of EUS in staging NSCLC Time Frame: at the end of the study	at the end of the study
Measure quality of life in patients that undergo surgery Time Frame: at the end of the study	at the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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