Skip to main content
OpenTrials
Completed

NCT Number: NCT00577746

Clinical Impact of EUS in Staging 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University Medical Center; Clarian Health

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Determine the accuracy of EUS in staging NSCLC

    Time frame: at the end of the study

Secondary outcomes

  1. Measure 5-year survival

    Time frame: 5 years

  2. Determine the cost benefit of EUS in staging NSCLC

    Time frame: at the end of the study

  3. Measure quality of life in patients that undergo surgery

    Time frame: at the end of the study

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Richard L. Roudebush VA Medical Center

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Dec 20, 2007
Registry last updated
Sep 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.