Clinical Impact of EUS in Staging NSCLC

NCT00577746 | Completed

• 2 other identifiers: 0306-37IRB # 0306-37
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung

Keywords

Non Small Cell Lung

Outcome Measures

Primary Outcomes (1)

• Determine the accuracy of EUS in staging NSCLC

  at the end of the study

Secondary Outcomes (3)

• 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

Study Arms (2)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Richard L. Roudebush VA Medical Center: collaborator

Study Sites (1)

Indiana University Medical Center; Clarian Health

Indianapolis, Indiana, 46202, United States

Location

Study Officials

• Julia LeBlanc, MD, MPH

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 20, 2007
• Study Start: June 1, 2006
• Primary Completion: July 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 5, 2014

Record last verified: 2014-09

Locations

US (1)