Clinical Impact of EUS in Staging NSCLC

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Richard L. Roudebush VA Medical Center
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00577746
First received: December 19, 2007
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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
Non Small Cell Lung

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Clinical Impact of Endoscopic Ultrasound (EUS) in Staging Non-small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Determine the accuracy of EUS in staging NSCLC [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure 5-year survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Determine the cost benefit of EUS in staging NSCLC [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
  • Measure quality of life in patients that undergo surgery [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: June 2006
Estimated Study Completion Date: December 2014
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577746

Locations
United States, Indiana
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
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00577746     History of Changes
Other Study ID Numbers: 0306-37, IRB # 0306-37
Study First Received: December 19, 2007
Last Updated: September 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Non Small Cell Lung

ClinicalTrials.gov processed this record on July 22, 2014